26 Jobs für Pharmaceutical Regulatory Affairs Specialist
Stellenangebote Pharmaceutical Regulatory Affairs Specialist Jobs
Job vor 6 Tagen bei Jobleads gefunden
Führungs-/ Leitungspositionen
Recruitment
Specialist-Regulatory and Quality DACH region Role Overview We are representing our client in the search for a Vice President, Regulatory
Affairs, based in Germany (remote) . This role provides [...]
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[...] executive-level responsibility for leading the regulatory function and shaping regulatory strategy across Germany and Europe within a growing pharmaceutical organisation. You will define and execute regulatory strategies covering clinical development, marketing authorisations, and lifecycle management of pharmaceutical products. Acting as the primary interface with regulatory authorities. You will ensure regulatory considerations are embedded across R D, Clinical Development, Quality, and Commercial functions to support efficient development timelines and successful [. .. ]
Job gestern bei Jobleads gefunden
Senior Logistics Compliance Specialist
• Barmelweid, Aargau
Homeoffice möglich
[. .. ] of all logistics and supply chain processes related to goods receipt, sampling, storage, and distribution within a GMP-regulated environment. Establish and maintain logistics SOPs in alignment with [...]
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[...] corporate and regulatory requirements. Lead local and cross-functional projects as Subject Matter Expert (SME) - from conceptual design through execution to successful completion. Represent the logistics function during regulatory inspections, customer audits, and client visits and presentations. Support deviation management and change control : act as second-level responsible for deviation investigations, [. .. ] operational excellence within the team. What were looking for : Bachelors or Masters degree in Supply Chain Management, Logistics, Business Administration, or equivalent qualification. Extensive professional experience in GMP-controlled pharmaceutical or biotech logistics, covering inbound, sampling, storage, and distribution processes. Proven expertise in process design, improvement, and implementation of logistics workflows. Strong project management skills with the ability to translate complex challenges into structured, actionable solutions. Advanced knowledge of SAP MM and EWM, particularly in inbound, warehouse management integration, picking, [. .. ]
Job gestern bei Jobleads gefunden
• Visp, Wallis
[. .. ] compliance with Good Distribution Practice (GDP) . Collaborate with stakeholders across the company to understand processes outside of QA to determine the best path forward. Verify that [...]
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[...] manufacturers of imported pharmaceutical products hold a valid GMP manufacturing license. Ensure the traceability of all purchases and sales of pharmaceutical products and record the necessary information. Confirm that documentation proving the quality of traded batches of drug substance, intermediate drug product, and bulk product is complete. Independently decide on distribution stops and batch [. .. ] quality complaints. Report quality issues to Swiss Medic according to requirements and within established deadlines. Address quality issues with the responsible Supplier/ Manufacturing site. Stay up-to-date with Swiss regulatory requirements, authority organisations, processes, and the overall environment. Ensure awareness and implementation of applicable regulations and disseminate this information to relevant internal and external stakeholders. Act as the primary contact for all quality issues for Swiss Medic, the Cantonal Health Authority, and Third-Party Manufacturers. Plan and perform internal audits. [. .. ] education and experience of the Deputy Fv P and delegate tasks as appropriate. Qualifications Degree in Chemistry, Pharmacy, or Biology. 5+ years of experience exclusive in quality assurance, operations, or regulatory affairs. Supervisory or management experience is preferred. Strong knowledge of QA systems and Gx P compliance requirements, including regulations and standards for devices, biologics, and pharmaceutical products. Excellent written and verbal communication skills in both English and German. Demonstrated ability to think strategically to meet or exceed compliance and business needs. Strong [. .. ] Full-time Job Function Quality Assurance Industries Biotechnology Research and Pharmaceutical Manufacturing Referrals increase your chances of interviewing at CTC Resourcing Solutions by 2x Get notified about new Quality Assurance Specialist jobs in Visp, Valais, Switzerland. #J-18808-Ljbffr 73438832 [. .. ]
Job gestern bei Jobleads gefunden
Senior Logistics Compliance Specialist
• Mönthal, Aargau
Homeoffice möglich
[. .. ] of all logistics and supply chain processes related to goods receipt, sampling, storage, and distribution within a GMP-regulated environment. Establish and maintain logistics SOPs in alignment with [...]
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[...] corporate and regulatory requirements. Lead local and cross-functional projects as Subject Matter Expert (SME) - from conceptual design through execution to successful completion. Represent the logistics function during regulatory inspections, customer audits, and client visits and presentations. Support deviation management and change control : act as second-level responsible for deviation investigations, [. .. ] operational excellence within the team. What were looking for : Bachelors or Masters degree in Supply Chain Management, Logistics, Business Administration, or equivalent qualification. Extensive professional experience in GMP-controlled pharmaceutical or biotech logistics, covering inbound, sampling, storage, and distribution processes. Proven expertise in process design, improvement, and implementation of logistics workflows. Strong project management skills with the ability to translate complex challenges into structured, actionable solutions. Advanced knowledge of SAP MM and EWM, particularly in inbound, warehouse management integration, picking, [. .. ]
Job vor 3 Tagen bei Jobleads gefunden
[. .. ] or task assignee (as needed) . Support implementation of Field Action. Support training planning and carry out reporting. Support the maintenance and management of the document retention [...]
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[...] system. Participate in Regulatory Affairs activities as needed. Education, Experience and Skills: Bachelors or Masters degree in a relevant scientific discipline. Prior experience within Quality Assurance within the pharmaceutical or healthcare environment. Basic knowledge of local regulations. Scientific knowledge. Administrative and project management skills. Ability to multitask and prioritise. Interpersonal and communication skills. Technical system skills, including word processing, spreadsheets, databases and online research. Fluent in English and French. Preferably with Dutch and German. The Application Process Once you [. .. ] come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it. Key words: Quality Assurance Officer, QA Officer, Quality Officer, Quality Assurance Specialist, QA Specialist, Quality Management System, QMS, Freelance, Temporary #J-18808-Ljbffr 73333771 [. .. ]
Job vor 6 Tagen bei Jobleads gefunden
Med Tech Customer Relationship Success Manager
• Berlin
[. .. ] Tech Customer Relationship Success Manager Location Berlin Paris Type Full-time Summary about the role We are looking for a dedicated Customer Relationship Success Manager with experience in [...]
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[...] quality and regulatory compliance in Med Tech to join our team in Paris, Berlin, or Vienna. This role focuses on ensuring the success and satisfaction of our large and mid-size medical device manufacturer clients. As a key member of our customer success team, you will build long-term relationships, drive customer happiness, [. .. ] to travel up to twice a month to meet with customers and attend industry events. What you need to be successful: Proven experience in Customer Success roles or medical or pharmaceutical compliance-related roles, such as Clinical or Regulatory Affairs Management Fluency in German and English, both written and verbal, additional languages are a plus Strong communication skills and the ability to build relationships with diverse stakeholders. Willingness to travel up to twice a month. Ability to work independently and manage multiple priorities in a dynamic environment. Knowledge of medical [. .. ] us. We are committed to supporting you in your professional and personal development, no matter whether you aim to become a great leader, renowned expert, successful entrepreneur, or high performing specialist. Staying healthy is a top priority. We help each other to reflect, stay in balance, and free up company budget to support healthy activities (food, subscriptions, team activities etc. ) . Competitive compensation, including the most employee friendly stock options. Such as fair leaver vesting terms, secondary exit participation and [. .. ]
Job vor 12 Tagen bei Jobleads gefunden
• Zürich
Führungs-/ Leitungspositionen
Global Medical
Affairs Director, Rare Haemato-Renal Disorders Category: Medical Affairs Location: Zurich, Switzerland, CH Are you looking for an exciting and leading role in supporting Novo Nordisk Rare Disease by [...]
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[...] extending our commitment and leadership in rare haemato-renal disorders? Are you looking to work in a fast-paced dynamic and international [. .. ] implementation of defined tactical projects Act as a strategic partner, providing expert medical leadership to guide development, submission, and launch planning for the asset. Provide medical input across product development, regulatory, pharmacoeconomic, marketing, and safety Lead development of the Integrated Evidence Planning (IEP) and execute relevant projects within evidence generation Develop educational materials, provide guidance and support to key affiliates in conjunction with the medical excellence team in the scientific dialogue and launch preparation activities for the asset Bringing the outside perspective, especially the patient and HCP (Health Care Professional) voice and network, to our organisation As a medical affairs specialist, you will play an important role in representing the Company interacting with external scientific leaders, study centres, patient advocacy groups and health authorities as needed This is an office-based position. International travel of approximately 10 per year can be expected. Qualifications You are motivated to improve the lives of [. .. ] are Medical Doctor/ Ph d/Pharm D with experience in immunology, rare bleeding or rare renal disorders. In addition: You bring more than 5 years of related work experience in the clinical/ pharmaceutical industry, including experience in global or regional medical affairs You have an established active network within the complement disorders field You have the ability to bring scientific and medical leadership in the communication with external KOLs and societies with credibility You have strong communications skills and experience working in cross-[. .. ]
Job vor 12 Tagen bei Jobleads gefunden
Global Medical Affairs Director, Rare Haemato-Renal Disorders
• Zürich
Führungs-/ Leitungspositionen
[. .. ] and international environment where you can innovate, drive change and improve patient care on a larger scale? If yes, then we have the perfect opportunity for you [...]
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[...] as Global Medical Affairs Director in the Rare Haemato-Renal Disorders Medical Affairs Team. The Global Medical Affairs Director will report to the Senior Global Medical Director, Rare Endocrine Haemato-Renal Disorders, Rare Disease Medical Affairs. This position is based at our office in Zurich, Switzerland. The Position As Global Medical Affairs Director, you [. .. ] implementation of defined tactical projects Act as a strategic partner, providing expert medical leadership to guide development, submission, and launch planning for the asset. Provide medical input across product development, regulatory, pharmacoeconomic, marketing, and safety Lead development of the Integrated Evidence Planning (IEP) and execute relevant projects within evidence generation Develop educational materials, provide guidance and support to key affiliates in conjunction with the medical excellence team in the scientific dialogue and launch preparation activities for the asset Bringing the outside perspective, especially the patient and HCP (Health Care Professional) voice and network, to our organisation As a medical affairs specialist, you will play an important role in representing the Company interacting with external scientific leaders, study centres, patient advocacy groups and health authorities as needed This is an office-based position. International travel of approximately 10 per year can be expected. Qualifications You are motivated to improve the lives of [. .. ] are Medical Doctor/ Ph d/Pharm D with experience in immunology, rare bleeding or rare renal disorders. In addition: You bring more than 5 years of related work experience in the clinical/ pharmaceutical industry, including experience in global or regional medical affairs You have an established active network within the complement disorders field You have the ability to bring scientific and medical leadership in the communication with external KOLs and societies with credibility You have strong communications skills and experience working in cross-[. .. ]
Job am 09.12.2025 bei Jobleads gefunden
[. .. ] overpayment depending on professional qualification and experience. Responsibilities In this role you will carry out the responsibilities within the framework of contribution to multidisciplinary teams including outcomes [...]
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[...] research, clinical research, regulatory affairs and marketing staff to support product development, launch, marketing, patient access acceleration, reimbursement and formulary acceptance. Deliver relevant data and tools to meet country Health Technology Assessment (HTA) / reimbursement/ funding and access needs within the region. Identify and pursue opportunities to obtain reimbursement and provide support in HTAs and [. .. ] Postgraduate degree in Economics, Health Economics or Life Science. Min 5 years experience in Reimbursement, Health economics, HTA and funding applications in a healthcare environment at a medical device or pharmaceutical or biotechnology or a specialist R HE in consulting company. Track record of developing and delivering reimbursement/ market access strategy in Germany is a must. Experience with strategic value story development and in conducting outcomes research project. Good understanding of the application, development and value assessment of health economic modelling. Excellent oral and written communication [. .. ]
Job am 26.11.2025 bei Jobleads gefunden
Senior Medical Affairs Specialist (German Speaking) (Hybrid)
• München, Bayern
Job Title: Sr. Medical
Affairs Specialist, Global Medical Communications Our Company Insulet Corporation is an innovative medical device company dedicated to simplifying the lives of people living with diabetes. Founded [...]
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[...] in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom, and healthier lives using our Omnipod product platform. In the [. .. ] industry guidelines on a global scale. Strategize and inform the development of evidence generation plans to provide meaningful data and impact innovation, support expansion of claims and indications, and satisfy regulatory requirements. Coordinate the implementation of data management systems with external vendors to ensure compliance standards are met and functionality is optimized. Develop and execute data dissemination plans to effectively communicate the clinical value of Insulets line of products to both internal and external audiences, including healthcare providers, people with diabetes, [. .. ] Relevant experience in a clinical, industry, or research setting is required (doctoratelevel education in lieu of some years of experience is acceptable) . Global experience in the Medical Affairs industry (pharmaceutical/ medical device) is preferred. Clinical or scientific background related to diabetes disease state and diabetes technologies (e. g. insulin pumps, continuous glucose monitors) is desirable. Fluency in English and German is required. Additional Information This position requires some travel up to 15 of the time (domestic and international) , but [. .. ]
Job am 25.11.2025 bei Jobleads gefunden
• München, Bayern
# # # Job Title: Sr. Medical
Affairs Specialist, Global Medical Communications # # # # # # Our Company # # # Insulet Corporation is an innovative medical device [...]
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[...] company dedicated to simplifying the lives of people living with diabetes. Founded in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom, [. .. ] global scale. # # # Strategize and inform the development of evidence generation plans to provide meaningful data and impact innovation, support expansion of claims and indications, and satisfy regulatory requirements. # # # Coordinate the implementation of data management systems with external vendors to ensure compliance standards are met and functionality is optimized. # # # Develop and execute data dissemination plans to effectively communicate the clinical value of Insulets line of products to both internal and [. .. ] industry, or research setting is required (doctorate-level education in lieu of some years of experience is acceptable) . # # # Global experience in the Medical Affairs industry (pharmaceutical/ medical #J-18808-Ljbffr 70490873 [. .. ]
Job am 23.11.2025 bei Jobleads gefunden
Regulatory And Clinical Start Up Specialist (Biotech)
• München, Bayern
Regulatory And Clinical Start Up
Specialist (Biotech) Join to apply for the Regulatory And Clinical Start Up Specialist (Biotech) role at Progressive Direct message the job poster from [...]
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[...] Progressive Regulatory and Start up Associate/ Specialist Responsible for oversight of assigned global clinical trials Review of regulatory submission documents and packages Support study teams as RA representative Preparation of responses to regulatory requests Support of regulatory interactions as applicable Negotiation of Budgets Contract Management Experience Requirements University degree or professional education e. g. Pharmaceutical/ Medical Technical Assistant with a minimum of 1-2 years professional experience preferably in pharmaceutical industry (an academic degree in natural sciences e. g. Bachelor would be an advantage) Fluent in written and verbal English Advanced knowledge and on-hands experience in using office software-e. g. MS Office Programs, [. .. ]
Job am 16.11.2025 bei Jobleads gefunden
• Allschwil, Basel- Landschaft
Führungs-/ Leitungspositionen
[. .. ] strategy, planning, and execution of the clinical development plan, including Phase 1 to 4 clinical studies in collaboration with cross-functional project team members, including clinical operations, clinical [...]
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[...] pharmacology, biometrics, regulatory, drug safety/ pharmacovigilance. The Executive Medical Director will also partner with medical affairs, HEOR, and commercial to provide guidance on publication strategy, data generation needs, and label expansion opportunities for marketed products. Your Contributions (include, but are not limited to) : Oversight of the clinical development strategy in the endocrinology therapeutic area Oversight of the design of clinical trials across early to late-[. .. ] of data and identification of evidence generation needs Adhere to Neurocrine Europe quality assurance system and compliance with the relevant SOPs Requirements: The appointed candidate will be a physician with specialist experience/ qualifications in endocrinology and/or a proven track record of clinical development in endocrinology products. MD qualified, ideally with specialist medical qualification in Endocrinology and previous experience in patient care At least 8 years experience in early or late stage clinical development in the pharmaceutical industry, ideally including experience with development of endocrinology products Excellent understanding of clinical trial design, execution, and regulatory requirements, including experience with regulatory agencies in the US and UK/ Europe Excellent communication and presentation skills, with the ability to effectively convey complex scientific information to internal and external stakeholders Strong [. .. ]
Job am 14.11.2025 bei Jobleads gefunden
Senior Reimbursement Analyst (m/f/d) - EMEA
• Wien
[. .. ] the following and other duties may be assigned:In this role you will carry out the responsibilities within the framework of contribution to multi-disciplinary teams including outcomes research, [...]
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[...] clinical research, regulatory affairs and marketing staff to support product development, launch, marketing, patient access acceleration, reimbursement and formulary acceptance. Deliver relevant data and tools to meet country Health Technology Assessment (HTA) / reimbursement/ funding and access needs within the region. Identify and pursue opportunities to obtain reimbursement and provide support in HTAs and [. .. ] Postgraduate degree in Economics, Health Economics or Life Science. Min 5 years experience in Reimbursement, Health economics, HTA and funding applications in a healthcare environment at a medical device or pharmaceutical or biotechnology or a specialist R HE in consulting company. Track record of developing and delivering reimbursement/ market access strategy in Germany is a must. Experience with strategic value story development and in conducting outcomes research project. Good understanding of the application, development and value assessment of health economic modelling. Excellent oral and written communication [. .. ]
Job am 06.11.2025 bei Jobleads gefunden
• Brandenburg
Führungs-/ Leitungspositionen
Direct message the job poster from Mantell Associates Mantell Associates is partnered with an established and growing CDMO specialised in solid dosage
pharmaceutical manufacturing, who is seeking a decisive [...]
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[...] and experienced Head of Supply Chain to lead its supply chain operations in Brandenburg. In this leadership role, youll ensure supply continuity, drive operational efficiency, and build a resilient, scalable supply chain capability. Head of Supply Chain-Responsibilities Lead the full supply chain function [. .. ] Manage and mentor a supply chain team, fostering a culture of reliability, continuous improvement, and operational excellence Oversee supplier selection, qualification, performance monitoring, and vendor management practices-ensuring contractual and regulatory alignment with pharmaceutical manufacturing standards Collaborate with Manufacturing, Quality Assurance, Regulatory Affairs, and Commercial teams to support material availability, process transfers, tech-scale-up, and new client onboarding Drive data-driven supply chain decision making by monitoring KPIs (inventory turnover, OTIF, cost savings, supplier performance) , identifying bottlenecks and initiating corrective actions Ensure compliance with GMP, GDP, regulatory guidelines and internal processes [. .. ] skills-able to navigate internal and external relationships effectively Based in Germany (Brandenburg region preferred) or willing to relocate; legal eligibility to work in Germany required Mantell Associates is a specialist Pharmaceutical and Life Science headhunting firm. For more information on this opportunity, contact us at +44 (0) 20 3854 7700. Job Details Seniority level: Director Employment type: Full-time Job function: Supply Chain, Manufacturing, and Distribution Industries: Biotechnology Research, Pharmaceutical Manufacturing, and Chemical Manufacturing Brandenburg, Germany #J-18808-Ljbffr [. .. ]
Job am 04.11.2025 bei Jobleads gefunden
Quality Regulatory Dossier Compliance Specialist (m/f/d)
• München, Bayern
Your profile Bachelors degree in scientific discipline (
Pharmaceutical Sciences, Chemistry, Biology, or related field) . Minimum of 45 years of experience in
Regulatory Affairs within the pharmaceutical industry. Solid [...]
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[...] understanding of pharmaceutical legislation and regulatory frameworks. Proven experience with EU registration procedures (MRP/ DCP MAAs, variations, extensions, and renewals) . Previous experience with non EU registrations is an advantage. Strong organizational and planning skills. Ability to interpret and effectively communicate regulatory requirements. Proactive, detailoriented, and [. .. ] products, it employs over 100 employees, and is recognized as a European leader in the manufacture and supply of clinical trial medications. Adragos Jura is seeking a Regulatory Dossier Compliance Specialist to support regulatory compliance and contribute to the submission and maintenance of national and international authorizations for our customers. The role will operate under the guidance of a Quality Compliance Systems Team Leader and will involve collaboration with crossfunctional teams both internally and with customers to ensure timely and accurate [. .. ]
Job am 01.11.2025 bei Jobleads gefunden
• Hannover, Niedersachsen
Senior Scientific Communications
Specialist English (Medical Writer/ Promo Review) Location: Fully Remote Europe Essentials Degree: Advanced degree in Pharmacy (Pharm D preferred) , advanced healthcare degree, or equivalent clinical [...]
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[...] experience. Experience: 24 years in scientific content creation within the pharmaceutical industry, medical education, or academia. Languages: Fluent in English and German (C1/ C2) . Position Summary The Senior Scientific Communications Specialist provides scientific and medical writing support across multiple therapeutic areas. This role ensures the delivery of accurate, balanced, and compliant content for internal stakeholders, healthcare professionals, and consumers. The position supports client needs, aligns with Medical Affairs and brand strategies, and may lead team members or client projects. Key Responsibilities Develop, review, and edit scientific and medical materials (e. g. , standard/custom responses, slide decks, manuscripts, dossiers, and promotional materials) . Ensure content accuracy, scientific integrity, and compliance with regulatory standards. Apply and maintain approved content and style guidelines in content management systems. Respond to medical information requests via email, web, or calls; conduct scientific exchanges as needed. Participate in scientific and brand training to maintain expertise. Meet quality and turnaround targets while adhering to legal, regulatory, and compliance policies. [. .. ]
Job am 06.10.2025 bei Jobleads gefunden
Senior Process Quality Specialist 1
• Mettmann, Nordrhein- Westfalen
Make your mark for patients We are looking for a Process Quality Excellence
Specialist who is detail-oriented collaborative and proactive to join us in our Global Clinical Sciences and [...]
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[...] Operations team based in our office in Slough UK; Brussels Belgium; or Monheim Germany. About the role You will be working in a team that ensures the highest standards of quality and compliance in [. .. ] in line with international regulations and best practices. Who youll work with You will be working in a diverse global team that collaborates closely with colleagues in Quality Patient Safety Regulatory Affairs and strategic partners. Together you will drive and continuous improvement across Global Clinical Sciences and Operations. What youll do Support the development and maintenance of quality and compliance infrastructure including policies procedures and best practices. Collaborate with cross-functional teams to ensure compliance with international regulations. Lead and coordinate audit [. .. ] looking for the following education experience and skills Bachelors degree or higher in a relevant field (e. g. life sciences pharmacy medicine or law) . Or significant experience in the pharmaceutical industry preferably in quality management or clinical development. In-depth knowledge of international clinical quality standards and regulatory guidelines. Strong analytical problem-solving and project management skills. Excellent communication and interpersonal skills with fluency in English. Experience in writing and maintaining standard operating procedures is essential. Are you ready to [. .. ]
Job am 03.10.2025 bei Jobleads gefunden
• Bonn, Nordrhein- Westfalen
Führungs-/ Leitungspositionen Freiberuflich
To support our global IT initiatives within a regulated
pharmaceutical environment we are looking for an experienced IT Service Now Compliance Validation Lead. In this role you will be [...]
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[...] responsible for ensuring that the Service Now platform is qualified, validated and maintained in a Gx Pcompliant manner while acting as the bridge between IT Quality Assurance and business stakeholders. Frame [. .. ] . Define and enforce Gx P controls audit trails and data integrity principles (ALCOA) . Support system reviews revalidation activities and change control processes. Act as IT lead during audits and regulatory inspections. Collaborate closely with QA IT Security Business Process Owners and Service Now developers. Provide training and ensure SOPs and Work Instructions are up to date. Requirements 5 years of IT compliance/ validation experience in the pharmaceutical or life sciences industry. 3 years working with Service Now in a regulated [. .. ] stakeholder management skills. Experience with validated Saa S platforms and vendor qualification processes is a plus. Fluency in English required. Preferred Certifications (nice-to-have) Service Now Certified System Administrator/ Implementation Specialist GAMP 5 or CSV-related certifications ITIL Foundation Certification Project Management Certification (PMP or PRINCE2) Employment Type : Full Time Experience : years Vacancy : 1 #J-18808-Ljbffr 64372232 [. .. ]
Job am 07.09.2025 bei Jobleads gefunden
Director of CMC
Führungs-/ Leitungspositionen
Director/ Senior Director, CMC role description and overview is provided below. Senior Business Manager-Global CDMO
Specialist Overview Senior-level position leading all CMC responsibilities in Germany within a cutting-edge CDMO [...]
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[...] company specializing in Small and Large Molecules and advanced therapies. This role offers the opportunity to contribute to the development of the CMC team across three verticals and participate in groundbreaking medical innovations. Responsibilities Lead [. .. ] department, managing a team of scientists and technical experts. Oversee method development, qualification, validation, and transfer for raw materials, intermediates, APIs, and finished products. Collaborate cross-functionally with Quality Control, Regulatory Affairs, and Manufacturing teams. Ensure analytical strategies align with ICH guidelines, EU GMP, and client-specific requirements. Drive technology innovation, including implementation of advanced analytical platforms (e. g. , LC-MS, q PCR, spectroscopy) . Serve as the technical lead during client audits, regulatory inspections, and project meetings. Develop and manage departmental [. .. ] submissions, and CTD sections for INd/IMPD filings. Stay abreast of industry trends, regulatory changes, and emerging technologies in analytical sciences. Requirements Ph D or MSc in Analytical Chemistry, Biochemistry, or Pharmaceutical Sciences 10+ years in analytical development, ideally within a CDMO or pharma/ biotech setting 4+ years in process development, ideally within a CDMO setting Proven leadership and team-building experience Deep expertise in GMP, ICH guidelines, and regulatory expectations Strong communication skills in German and English Desired Competencies Hands-on [. .. ]
Job am 29.08.2025 bei Jobleads gefunden
Global Anti-Infectives Marketing Lead (m/f/d)
• Holzkirchen, Bayern
Führungs-/ Leitungspositionen
[. .. ] scope) Develop and execute data-driven and customer-centric omnichannel strategies that enhance patient HPC engagement across digital and traditional channels Ensure Anti-Infectives marketing strategies fully comply with any [...]
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[...] regulatory and other compliance requirements Partner with Marketing Analytics Business Insights teams to evaluate the effectiveness of marketing strategies Prioritize activities and manage global marketing budget for Anti-Infectives brands products in scope Provide strategic leadership on commercial topics to cross-functional Global Program Team members (i. e. , Regulatory Affairs, Clinical, Technical Development, STO, Medical, Finance, etc. ) Actively engage and ensure effective pro-active communication with key stakeholders in Global, Regions and Countries Monitor competitive environment, customer insights and brand performance to quickly identify and implement plan changes if needed Present to senior management on strategy and action plans [. .. ] advance as a note on your CV. #Sandoz Seniority level Seniority level Mid-Senior level Employment type Employment type Full-time Job function Job function Marketing and Sales Industries Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Sandoz in Deutschland by 2x Sign in to set job alerts for Global Marketing Specialist roles. Marketing Manager (f/m/d) - Germany Pure Players Nordics Product Marketing Manager (m/f/d) - hybrid Content Social Media Marketing Managerin (m/w/d) Product Marketing Manager-Travel, Auto and Finance-DACH Digital Brand Marketing Manager (m/w/d) Senior e Mobility Marketing Manager-Munich Consumer Marketing Manager [. .. ]
Job am 26.08.2025 bei Jobleads gefunden
Senior Manager (m/w/d) IT System Operations Regulatory Affairs CMC
• Pfaffenhofen an der Ilm, Bayern
Abgeschlossenes Studium
Work-Life-Balance
Senior Manager (m/w/d) IT System Operations
Regulatory Affairs CMC Join to apply for the Senior Manager (m/w/d) IT System Operations Regulatory Affairs CMC role at Daiichi Sankyo Europe Gmb [...]
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[...] H Senior Manager (m/w/d) IT System Operations Regulatory Affairs CMC 1 day ago Be among the first 25 applicants Join to apply for the Senior Manager [. .. ] Benefits Work-Life-Balance Growth and Development Health and Wellbeing Support Seniority level Seniority level Mid-Senior level Employment type Employment type Full-time Job function Job function Other Industries Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Daiichi Sankyo Europe Gmb H by 2x Get notified about new Senior Manager (m/w/d) IT System Operations Regulatory Affairs CMC jobs in Pfaffenhofen an der Ilm, Bavaria, Germany. Regional Risk and Quality Assurance Manager (f/m/d) Finance Manager/ Senior Finance Professional (m/w/d) Interimprojekte Engagement Manager (m/f/d) - Allianz Consulting-Finance Transformation Customer Success Operations Manager (m/w/d) Experte (m/w/d) IT-Governance/ IT-Compliance Specialist Data and AI Strategy and Compliance (all genders) Praktikant/ Werkstudent (m/w/d) Compliance Were unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr 59958892 [. .. ]
Job am 03.07.2025 bei Jobleads gefunden
Head of Engineering
• Hamburg
Führungs-/ Leitungspositionen
[. .. ] smooth handoffs from R d/development labs into GMP manufacturing Oversee technical troubleshooting, deviations, and root cause investigations; proactively address performance bottlenecks, equipment or facility constraints, and process [...]
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[...] drift Maintain regulatory and GMP compliance (EU GMP, EMA, German regulatory bodies) in all operational and technical activities; ensure site readiness for audits and inspections Collaborate closely with Supply Chain, Quality Assurance, Regulatory Affairs, and Commercial teams to support product launch readiness and client commitments Head of Engineering-Requirements Deep experience having worked in a CDMO environment, ideally leading technical operations or similar senior operational roles for drug product manufacturing Strong background in drug product (finished dosage forms-sterile or non-sterile) manufacturing operations, [. .. ] metrics, and ensuring throughput, quality, GMP compliance, and cost performance Based in or able to relocate to Hamburg, Germany, with willingness for hybrid on-site presence Mantell Associates is a specialist Pharmaceutical and Life Science headhunting firm. For more information on this opportunity, contact us at +44 (0) 20 3854 7700. #J-18808-Ljbffr 54039943 [. .. ]
Job vor 11 Tagen bei Neuvoo gefunden
West Pharmaceutical Services
Senior Specialist, Fill Finish Process
• Berlin
Job Summary In this role Senior
Specialist, Fill Finish Process, you will join our growing team, and support customers with technical questions related to our Integrated Systems portfolio, mainly [...]
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[...] focusing on fill/ finish topics, such as glass handling, rubber component transportation, plunger setting, outer packaging. Youll bring hands-on experience and deep fill/ finish process knowledge, you [. .. ] Prepare and manage process documentation (protocols, change controls) Other duties as assigned Education Bachelors degree in Engineering or equivalent experience Work Experience Minimum 5 years of hands-on experience in pharmaceutical processing and packaging technology, working with multiple different fill/ finish lines, aseptic filling, and isolator technology Preferred Knowledge, Skills and Abilities Profound knowledge in filling line technology Ability to handle scientific technical content with legal and regulatory understanding, Ability to make sound and independent judgments, Ability to clearly and concisely communicate and comprehend complex ideas and concepts Sound knowledge of scientific terminology, medical, pharmaceutical, and research concepts Sound skills in scientific writing, grammar, and spelling in English Must be able to multi-task, work under time constraints, [. .. ] accuracy, and overall quality of work Adept in word processing, spreadsheets, tables, presentations, and graph generation Capability to work well in a matrix environment with R D, QA, Legal, Regulatory Affairs, Product Management, Technical Customer Support, Sales, Marketing, Product Technology Service, and Global Communications Ability to analyze research data and review experimental protocols Entrepreneurial problem solver with strong troubleshooting skills Additional Requirements Must be able to travel up to 40 of the time, both domestically and internationally, and sometimes on short [. .. ]
Job am 05.12.2025 bei Neuvoo gefunden
Merz Aesthetics GmbH
Medical Education Editor (m/f/d) , Global Medical Education, Medical Education Editor (m/f/d) , Global Medical Education at Merz Aesthetics GmbH softgarden
• Frankfurt, Hessen
[. .. ] standards, guidelines and scientific insights, while developed and published education content is of high accuracy. In order to maintain familiarity with current health care industry trends, aesthetics [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] and cosmetic medicine, pharmaceutical practices you conduct information gathering through our company-led learning platforms and networks, and independently through literature research, congress participations and KOL exchange. You maintain close collaboration and exchange internally with our global and regional Medical Affairs Teams, R D, marketing, regulatory, legal, and externally, with international thought leaders and vendors to ensure strategic alignment and market need is met. You work in close collaboration with the medical team and external thought leaders/ health care professionals on content creation events and schedules (e. g. filming activities of injection demonstrations, cadaver dissections, talks, [. .. ] training : Your personal and professional development is the key to success for us. To foster this, we conduct regular development discussions and facilitate a wide range of management and specialist training courses, soft skills courses, e-learning courses, language courses and coaching sessions. Find out more about our benefits at https:/ / careers. merz-aesthetics. com. We look forward to your application Apply Online View more jobs Imprint Privacy Policy Powered by softgarden 71737564 [. .. ]
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Häufig gestellte Fragen
Wieviel verdient man als Pharmaceutical Regulatory Affairs Specialist pro Jahr?
Als Pharmaceutical Regulatory Affairs Specialist verdient man zwischen EUR 60.000,- bis EUR 100.000,- im Jahr.
Wieviele offene Stellenangebote gibt es für Pharmaceutical Regulatory Affairs Specialist Jobs bei unserer Jobsuche?
Aktuell gibt es auf JobRobot 26 offene Stellenanzeigen für Pharmaceutical Regulatory Affairs Specialist Jobs.
In welchen Bundesländern werden die meisten Pharmaceutical Regulatory Affairs Specialist Jobs angeboten?
Die meisten Stellenanzeigen für Pharmaceutical Regulatory Affairs Specialist Jobs werden derzeit in Bayern (6 Jobs), Berlin (2 Jobs) und Nordrhein-Westfalen (2 Jobs) angeboten.
Zu welchem Berufsfeld gehören Pharmaceutical Regulatory Affairs Specialist Jobs?
Pharmaceutical Regulatory Affairs Specialist Jobs gehören zum Berufsfeld Regulatory Affairs & Management.
