177 Jobs für Drug Regulatory Manager
Stellenangebote Drug Regulatory Manager Jobs
Job vor 6 Tagen bei StepStone gefunden
Miltenyi Biotec B. V. Co. KG
• Bergisch Gladbach
Homeoffice möglich
[. .. ] T cell product, is currently undergoing pivotal clinical trials on a global scale. Join our highly professional team in bringing new medicines to the market. Job Description [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] As Senior Project Manager, you will support global drug development programs from early development through to worldwide regulatory approval. In this role, you will lead the cross-functional project management effort, ensuring that timelines, interdependencies, and critical deliverables are aligned across all contributing functions. You will serve as the central operational driver to keep the project team coordinated, on track, and focused on achieving key development milestones. Key [. .. ]
Job am 13.09.2025 bei Jobleads gefunden
Medical Director Multiple Sclerosis
• Basel, Basel- Stadt
Führungs-/ Leitungspositionen
[. .. ] and/or support cross-functional teams to design and execute clinical development plans from Phase 1 through Phase 2 (proof-of-concept) Coach Clinical Scientists in a line-or functional-
manager status Closely [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] interface with project team leaders as well as safety, clinical pharmacology, clinical operations, biostatistics, regulatory, research and biomarker groups and other members of project teams Lead and/or support internal stakeholder management and governance interactions around project plans and therapeutic area strategy Lead and/or support external engagements with advisory boards, site investigators, health authorities, and other key stakeholders Provide clinical input to programs in [. .. ] a similar field. Board certification and fellowship training or research experience in relevant areas is preferred You bring at least 5 years of experience in longitudinal clinical research, preferably in drug development or clinical trials You hold a strong track record of scientific excellence in the field, evidenced by substantial achievement in designing and implementing clinical trials and/or a high level of scholarship in industry or academia You have experience in clinical drug development within the industry, ideally in the [. .. ]
Job am 10.09.2025 bei Jobleads gefunden
• Basel, Basel- Stadt
Führungs-/ Leitungspositionen
[. .. ] and/or support cross-functional teams to design and execute clinical development plans from Phase 1 through Phase 2 (proof-of-concept) Coach Clinical Scientists in a line-or functional-
manager status Closely [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] interface with project team leaders as well as safety, clinical pharmacology, clinical operations, biostatistics, regulatory, research and biomarker groups and other members of project teams Lead and/or support internal stakeholder management and governance interactions around project plans and therapeutic area strategy Lead and/or support external engagements with advisory boards, site investigators, health authorities, and other key stakeholders Provide clinical input to programs in [. .. ] a similar field. Board certification and fellowship training or research experience in relevant areas is preferred. You bring at least 5 years of experience in longitudinal clinical research, preferably in drug development or clinical trials. You hold a strong track record of scientific excellence in the field, evidenced by substantial achievement in designing and implementing clinical trials and/or a high level of scholarship in industry or academia. You have experience in clinical drug development within the industry, ideally in the [. .. ]
Job gestern bei Jobleads gefunden
Senior MSAT Process Manager-Biopharma Manufacturing Leader
• Basel, Basel- Stadt
Führungs-/ Leitungspositionen
A leading biopharmaceutical company is seeking a Senior Process
Manager MSAT to oversee the compliant and reliable manufacturing of clinical and commercial products. This role involves leading MSAT projects, optimizing [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] manufacturing processes, and ensuring compliance with regulatory guidelines. The ideal candidate has over 5 years of experience in drug product manufacturing, a strong scientific background, and excellent collaboration skills. Join us to make a meaningful impact in the lives of patients with rare diseases. #J-18808-Ljbffr 73332942 [. .. ]
Job vor 3 Tagen bei Jobleads gefunden
Senior Business Development
Manager, TIDES Senior Business Development Manager, TIDES Direct message the job poster from Wu Xi Chemistry Busy hiring outstanding Scientific, Sales and Operations professionals for Wu Xi [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] App Tec. Come join us on our journey to realize every drug can be Overview: The incumbent will uncover and cultivate business relationships and opportunities to generate revenue with prospective and existing clients for Wu Xi TIDES in the EU, a Wu Xi App Tec company. To support the growth of emerging oligo and peptide CMC development and Manufacturing (CDMO) business. The [. .. ] sales and marketing campaigns. Increase awareness of Wu Xi TIDES marketing initiatives including scheduling meetings at tradeshows and promoting registrations for webinars and seminars. Maintains knowledge of industry trends, funding, regulatory influence, mergers and acquisitions, in-out licensing of products/ technologies, government/ private grants and contacts, new drug development and approvals, related patent grants and notifications, market growth of small, med, and large cap companies. Develops a social network of industry related contacts via Linked In and other social networking platforms. [. .. ]
Job vor 3 Tagen bei Jobleads gefunden
Technical Drug Product Manufacturing Manager Sterile
• Zug
A leading biopharmaceutical company is seeking a Technical Manufacturing
Manager to oversee the
drug product manufacturing process. The role includes managing technical operations, ensuring compliance with
regulatory [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] standards, and optimizing manufacturing processes. Candidates should have over 5 years of experience in pharmaceutical manufacturing, strong problem-solving skills, and the ability to work in cross-functional teams. A degree in life sciences or engineering is required, and this position is based in Zug, Switzerland. #J-18808-Ljbffr [. .. ]
Job vor 3 Tagen bei Jobleads gefunden
• Zug
Senior
Manager,
Drug Substance MSAT Apellis Pharmaceuticals Location: Zug, Switzerland (requires 23 days office presence per week) Employment type: Fulltime, Mid Senior level Job Function: Other Summary As [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] part of the MSAT team, the Senior Manager of Drug Substance (DS) Manufacturing Science and Technology (MSAT) will lead tech transfer, process qualification, and validation [. .. ] issues within scope. Ensure qualification/ validation of processes, facilities, equipment, raw materials, and cleaning methods per GMP and global health regulations. Collaborate with crossfunctional teams (PM, QC, QA, Supply Chain, Regulatory) for tech transfer, scaleup, and PPQ. Build strong relationships with development and manufacturing partners; coordinate with internal teams. Confirm equipment qualification as part of process validation (installation, operation, performance) . Identify opportunities for continuous process improvement via trend analysis, technology advances, and industry standards. Support evaluation of major deviations, root [. .. ]
Job vor 3 Tagen bei Jobleads gefunden
Senior DP Process Lead, MSAT
• Basel, Basel- Stadt
A global biopharmaceutical company is looking for a Senior Process
Manager MSAT in Basel, Switzerland. In this role, you will oversee
drug product manufacturing processes, lead MSAT projects, [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] and ensure compliance with regulatory standards. You should have over 5 years of experience in aseptic drug product manufacturing and a relevant university degree. The position emphasizes cross-functional collaboration and a commitment to innovative solutions for treating rare diseases. Competitive benefits and a collaborative environment are offered. #J-18808-Ljbffr 73203889 [. .. ]
Job vor 3 Tagen bei Jobleads gefunden
• Zug
Manager, Manufacturing Technical
Drug Product Opportunity awaits those up to the challenge of developing transformative therapies across a broad range of debilitating diseases. At Apellis, we are driven [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] by science and inspired by patients. We are looking for a skilled and proactive Technical Manufacturing Manager Drug Product to join our Technical Operations team. This [. .. ] Coordinate manufacturing schedules with CMOs to ensure timely availability of materials, especially for long lead-time items. Review batch production records and manufacturing instructions to ensure compliance with c GMP and regulatory standards. Collaborate with QA to assess deviations, investigations, CAPAs, and supplier risk mitigation strategies. Monitor and evaluate CMO performance, identifying risks and opportunities, and initiating corrective actions when needed. Apply risk management and root cause analysis to identify and address compliance risks. Drive process optimization, using datadriven insights (e. g. [. .. ]
Job vor 3 Tagen bei Jobleads gefunden
Senior Process Manager MS T
• Basel, Basel- Stadt
Job Description About the role As Senior Process
Manager MSAT, you will play a pivotal role in ensuring the compliant, reliable, and sustainable manufacturing of Sobis clinical and commercial [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] products. You will be part of the Manufacturing Science and Technology (MSAT) team within the Global CMC, Science Technology Department (GCSAT) , contributing your expertise to optimize and manage manufacturing [. .. ] at our Global Headquarters in Stockholm, Sweden or Global hub in Basel, Switzerland, reporting directly to Group Head Aseptics DP. Key Responsibilities Serve as the subject matter expert (SME) for drug product (DP) manufacturing and validation. Lead and execute MSAT projects focused on process and cost improvements as part of lifecycle management. Participate in activities related to internal and external manufacturing, including process changes, major deviations, risk assessments, and CAPAs. Issue, review, and approve internal and external SOPs and manufacturing instructions. [. .. ] product manufacturing. Recognized as an expert in aseptic drug product manufacturing. Demonstrated experience working in crossfunctional teams, with the ability to multitask, prioritize, and make effective decisions. Strong knowledge of regulatory guidelines, experience in communication with regulatory authorities, and proficiency in preparing regulatory documentation. Fluent in English, with excellent oral and written communication skills. How to apply We have an ongoing selection process in this recruitment and ask you to send your application as soon as possible. Click apply and include [. .. ]
Job vor 3 Tagen bei Jobleads gefunden
• Basel, Basel- Stadt
Führungs-/ Leitungspositionen
[. .. ] to give stakeholders a clear and datadriven view of pipeline status and progress. Ensure consistency of portfolio information for internal decisionmakers and for external reporting requirements (e. [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] g. annual reports regulatory filings) . Governance Decision Support: Contribute insights to inform portfolio governance decisionmaking on project tradeoffs and investment decisions (e. g. internal pipeline projects vs. external Business Development Licensing opportunities) . Prepare project assessments and portfolio positioning analyses in partnership with Strategy Growth (S G) and other key stakeholders to support [. .. ] portfolio analytics and benchmarks for senior leadership supporting strategic decisionmaking and effective resource allocation within specific therapeutic or development units. Integrator Relationship Management: Act as an integrator and key relationship manager for the pipeline. Serve as a key partner to Biomedical Research Development Commercial and S G units by providing strategic and financial insights and acting as a liaison for all pipelinerelated matters. Tools Capabilities Development: Establish and drive innovative portfolio analytics tools and systems to standardize data inputs (such as [. .. ] English required spoken written Industry Experience Significant pharmaceutical industry experience with exposure to development/ or processespn3Cross Functional Leadershipdepth crossfunctional team experience (e. g. project management or similar leadership roles in drug development) . Experience in a major consultancy with work on international multidisciplinary drug development teams can be considered equivalent. Analytical Skills Proven experience in handling and modeling complex financial and commercial data with indepth knowledge of forecasting and valuation methodologies. Familiarity or direct experience with applied decision analysis R D [. .. ]
Job vor 4 Tagen bei Jobleads gefunden
Medical Affairs Manager
• Düsseldorf, Nordrhein- Westfalen Duesseldorf
Medical Affairs
Manager (m/f/D) Tasks Provide recommendation on Patient-Reported Outcomes (PRO) endpoints, instruments and assessment schedule based upon trial population, comparator and DS strategic objectives Contribute to Patient Experience [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] Data (PED) / PRO-specific aspects of protocol profile, clinical trial protocol and informed consent form development Work with PRO implementation [. .. ] provide Senior Review) Respond to study team queries related to PED Respond to PRO-specific questions received in Requests for Information (RFIs) as part of EU CTR submissions Contribute to regulatory briefing documents as needed Contribute to HTA interactions as needed Consult the HEOR Asset Lead upon request of additional evidence generation to refine the selected PRO strategy for a given trial Review externally-sponsored and real-world study protocols when PED are included Perform the activities described above for ongoing [. .. ] of PROs with key external stakeholders such as FDA, EMA and relevant HTAs Knowledge and experience of Oncology therapy areas is strongly preferred Demonstrates understanding and (advanced) knowledge of key drug development processes, plans, studies, and strategies including any aspects of drug development. Uses knowledge to the organizations advantage; generates new ideas and enables the organization to improve business performance. Demonstrates understanding and (advanced) knowledge of PRO methods and instruments, and the issues and challenges of applying these alongside clinical studies [. .. ]
Job vor 4 Tagen bei Jobleads gefunden
• Dortmund, Nordrhein- Westfalen
Medical Affairs
Manager (m/f/D) Tasks Provide recommendation on Patient-Reported Outcomes (PRO) endpoints, instruments and assessment schedule based upon trial population, comparator and DS strategic objectives Contribute to Patient Experience [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] Data (PED) / PRO-specific aspects of protocol profile, clinical trial protocol and informed consent form development Work with PRO implementation [. .. ] provide Senior Review) Respond to study team queries related to PED Respond to PRO-specific questions received in Requests for Information (RFIs) as part of EU CTR submissions Contribute to regulatory briefing documents as needed Contribute to HTA interactions as needed Consult the HEOR Asset Lead upon request of additional evidence generation to refine the selected PRO strategy for a given trial Review externally-sponsored and real-world study protocols when PED are included Perform the activities described above for ongoing [. .. ] of PROs with key external stakeholders such as FDA, EMA and relevant HTAs Knowledge and experience of Oncology therapy areas is strongly preferred Demonstrates understanding and (advanced) knowledge of key drug development processes, plans, studies, and strategies including any aspects of drug development. Uses knowledge to the organizations advantage; generates new ideas and enables the organization to improve business performance. Demonstrates understanding and (advanced) knowledge of PRO methods and instruments, and the issues and challenges of applying these alongside clinical studies [. .. ]
Job vor 4 Tagen bei Jobleads gefunden
Medical Affairs Manager
• Hamburg
Medical Affairs
Manager (m/f/D) Tasks Provide recommendation on Patient-Reported Outcomes (PRO) endpoints, instruments and assessment schedule based upon trial population, comparator and DS strategic objectives Contribute to Patient Experience [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] Data (PED) / PRO-specific aspects of protocol profile, clinical trial protocol and informed consent form development Work with PRO implementation [. .. ] provide Senior Review) Respond to study team queries related to PED Respond to PRO-specific questions received in Requests for Information (RFIs) as part of EU CTR submissions Contribute to regulatory briefing documents as needed Contribute to HTA interactions as needed Consult the HEOR Asset Lead upon request of additional evidence generation to refine the selected PRO strategy for a given trial Review externally-sponsored and real-world study protocols when PED are included Perform the activities described above for ongoing [. .. ] of PROs with key external stakeholders such as FDA, EMA and relevant HTAs Knowledge and experience of Oncology therapy areas is strongly preferred Demonstrates understanding and (advanced) knowledge of key drug development processes, plans, studies, and strategies including any aspects of drug development. Uses knowledge to the organizations advantage; generates new ideas and enables the organization to improve business performance. Demonstrates understanding and (advanced) knowledge of PRO methods and instruments, and the issues and challenges of applying these alongside clinical studies [. .. ]
Job vor 4 Tagen bei Jobleads gefunden
• München, Bayern
[. .. ] Bridge preclinical data with clinical study design and execution Provide scientific leadership across translational, biomarker and early development activities Act as a key cross-functional partner to research, [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] clinical and regulatory teams Lead and develop a small, established translational science team (4 members) Experience Ph D or MD in Translational Medicine, Oncology, Pharmacology or related field 10+ years experience in translational sciences within oncology drug development Demonstrated success advancing at least programs from preclinical to IND and Phase I Strong background in solid tumours Experience relevant to radiopharmaceutical or targeted oncology therapies Proven cross-functional leadership in early development settings Comfortable operating both strategically and hands on with scientific data Ideal Profile Senior scientific leader, not just a big company manager Able to guide teams while remaining close to the science Pragmatic, decisive, and data driven Clear communicator with strong stakeholder influence Whats Offered Senior leadership position with meaningful impact on early oncology programs Opportunity to shape translational strategy at a pivotal stage of development Competitive compensation including base salary, bonus [. .. ]
Job vor 4 Tagen bei Jobleads gefunden
Medical Affairs Manager
• Leipzig, Sachsen
Medical Affairs
Manager (m/f/D) Tasks Provide recommendation on Patient-Reported Outcomes (PRO) endpoints, instruments and assessment schedule based upon trial population, comparator and DS strategic objectives Contribute to Patient Experience [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] Data (PED) / PRO-specific aspects of protocol profile, clinical trial protocol and informed consent form development Work with PRO implementation [. .. ] provide Senior Review) Respond to study team queries related to PED Respond to PRO-specific questions received in Requests for Information (RFIs) as part of EU CTR submissions Contribute to regulatory briefing documents as needed Contribute to HTA interactions as needed Consult the HEOR Asset Lead upon request of additional evidence generation to refine the selected PRO strategy for a given trial Review externally-sponsored and real-world study protocols when PED are included Perform the activities described above for ongoing [. .. ] of PROs with key external stakeholders such as FDA, EMA and relevant HTAs Knowledge and experience of Oncology therapy areas is strongly preferred Demonstrates understanding and (advanced) knowledge of key drug development processes, plans, studies, and strategies including any aspects of drug development. Uses knowledge to the organizations advantage; generates new ideas and enables the organization to improve business performance. Demonstrates understanding and (advanced) knowledge of PRO methods and instruments, and the issues and challenges of applying these alongside clinical studies [. .. ]
Job vor 4 Tagen bei Jobleads gefunden
• München, Bayern
[. .. ] the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5, 000 people across 40+ countries. Why Medpace? When you join Medpace, you become part of a team dedicated to supporting the [. .. ] size Companies in 2021 Medpace ranks amongst top CROs for site ratings across all 10 important attributes including CRA training, preparation organization, accessibility of staff, open communication, and ensuring timely drug availability Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A member of our recruitment team will review your qualifications and, if interested, you will be contacted for an interview. #J-18808-Ljbffr 73157696 [. .. ]
Job vor 4 Tagen bei Jobleads gefunden
Medical Affairs Manager
• Essen, Nordrhein- Westfalen
Medical Affairs
Manager (m/f/D) Tasks Provide recommendation on Patient-Reported Outcomes (PRO) endpoints, instruments and assessment schedule based upon trial population, comparator and DS strategic objectives Contribute to Patient Experience [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] Data (PED) / PRO-specific aspects of protocol profile, clinical trial protocol and informed consent form development Work with PRO implementation [. .. ] provide Senior Review) Respond to study team queries related to PED Respond to PRO-specific questions received in Requests for Information (RFIs) as part of EU CTR submissions Contribute to regulatory briefing documents as needed Contribute to HTA interactions as needed Consult the HEOR Asset Lead upon request of additional evidence generation to refine the selected PRO strategy for a given trial Review externally-sponsored and real-world study protocols when PED are included Perform the activities described above for ongoing [. .. ] of PROs with key external stakeholders such as FDA, EMA and relevant HTAs Knowledge and experience of Oncology therapy areas is strongly preferred Demonstrates understanding and (advanced) knowledge of key drug development processes, plans, studies, and strategies including any aspects of drug development. Uses knowledge to the organizations advantage; generates new ideas and enables the organization to improve business performance. Demonstrates understanding and (advanced) knowledge of PRO methods and instruments, and the issues and challenges of applying these alongside clinical studies [. .. ]
Job vor 5 Tagen bei Jobleads gefunden
[. .. ] School Diploma or GED (accredited) and four (4) years of relevant work experience. Experience: Two (2) years of relevant work experience (in addition to education requirement) . [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] RCRA and DOT regulatory compliance experience required. OSHA 24-Hour HAZWOPER Certification required. Pre-assignment and/or pre-hire customerspecific drug and/or alcohol testing may be required by certain customercontract requirements. Such testing may include urinalysis, oral swab, drug hair follicle testing and/or alcohol testing. Plans and directs all onsite activities at client location in relation to the storage, transportation and disposal of hazardous and nonhazardous wastes and other [. .. ]
Job vor 5 Tagen bei Jobleads gefunden
Technical Leader Civil Structural Engineering (Remote Eligible, U. S. )
Führungs-/ Leitungspositionen
[. .. ] other nuclear regulator) design certification requirements Establish and maintain technical oversight of the applicable regulations (e. g. , US, other national, or global region) Have other duties [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] as assigned by Manager Interface with internal and external customers, suppliers, partners, licensing, the NRC and international regulatory authorities on technical issues Incorporate design requirements into analyses and design documents Support GE Vernova Hitachi Nuclear Energy (GVH) quality requirements, including participation in design reviews, initiating and Manage the design, analysis, or evaluation of assigned systems using sound engineering principles and adhering to business standards, practices, procedures, and product/ [. .. ] Vernova will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable) . Relocation Assistance Provided: No #LI-Remote-This is a remote position Application Deadline: January 23, 2026 For candidates applying to a U. S. based position, the pay range for this position is between 111, 200.00 and 185, 400.00. The Company pays a geographic [. .. ]
Job vor 6 Tagen bei Jobleads gefunden
Clinical Quality Manager (m/f/d) - Cell Therapy
• Hamburg
[. .. ] With us, every single employee puts patients first. Make an impact in advancing Cell Therapy by ensuring the highest standards of quality and compliance. We are seeking [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] a Clinical Quality Manager (CQM) (m/f/d) - Cell Therapy to join our Cell Therapy Clinical Operations (CTCO) team. In this role, you will collaborate with the Business Processes, Quality Learning (BPQL) team to provide expert guidance and coaching, enabling the successful delivery of Cell Therapy studies by the Site Management and Monitoring [. .. ] this role, you will provide guidance and advice to Site Management and Monitoring (SMM) teams on applying GCP principles, ensuring their work meets the highest quality standards. You will use regulatory guidance, global standards, and SOPs to offer compliance advice and identify opportunities for improvement. When needed, you will recommend and communicate these improvements to Business Process System Owners (BPOs) . Additionally, you will support SMM management by consulting on compliance learning needs and facilitating training delivery. While overall accountability for [. .. ] experience in clinical operations. Ideally, you have: A Bachelor of Science in a relevant discipline or equivalent professional experience. At least 4 years of operational and/or quality experience in drug development within a pharmaceutical or clinical setting. Solid understanding of business processes, technology, and clinical study information systems. Proven time management skills and the ability to deliver timely responses and support to internal and external stakeholders. Experience working successfully and collaboratively with both internal teams and external partners. Excellent written [. .. ]
Job vor 8 Tagen bei Jobleads gefunden
Senior CMC Manager
• München, Bayern
The Senior CMC
Manager will play a key leadership role in defining and delivering CMC strategy across the companys gene therapy pipeline. You will oversee internal and external activities [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] spanning process development, GMP manufacturing, analytical development, and regulatory documentation. This position requires strong technical depth, exceptional cross-functional collaboration, and the ability to drive complex programmes toward clinical milestones. Key Responsibilities Lead the end-to-end CMC strategy for AAV gene therapy programmes from research handover through Phase I/ II clinical studies. Manage CDMOs for both drug substance (AAV vector manufacturing) and drug product (fill-finish) , ensuring adherence to timelines, budgets, and quality expectations. Oversee process development activities, including upstream/downstream optimisation (HEK293 or suspension-based systems) , scale-up, and tech transfer to GMP facilities. Drive analytical method development and qualification, including potency assays, q PCR/ [. .. ]
Job vor 8 Tagen bei Jobleads gefunden
Clinical Safety Manager-Pharmacovigilance/ Drug Safety
• München, Bayern
Job Summary Our European activities are growing rapidly, and we are currently seeking a full-time, office-based Clinical Safety
Manager to join our team in Munich. This position plays a [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] key role in the pharmacovigilance process at Medpace, working in a team to accomplish tasks and projects that are instrumental to the companys success. If you want an exciting career where you can use your previous expertise and develop and [. .. ] multiple programs. Experience in writing departmental SOPs and Work Instructions. Experience in PSMF generation and maintenance. Experience in CCDS/ RMP/ Sm PC writing and maintenance. Comprehensive knowledge of global clinical safety regulatory requirements. Excellent verbal and written communication skills. Strong leadership, mentoring, and motivational skills. Exceptional teamwork skills. Ability to work independently. We kindly ask to submit applications in English. Medpace Overview Medpace is a full-service clinical contract research organization (CRO) . We provide Phase I-IV clinical development services to [. .. ]
Job vor 9 Tagen bei Jobleads gefunden
Customer Experience Manager, South Germany Munich, Germany; Nuremberg, Germany; Stuttgart, Germany
• München, Bayern
Customer Experience
Manager, South Germany Level of position: Associate Director Position type: 60 field-based, 40 (home-) office based How will your role help us transform hope into reality? We [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] are looking for a highly motivated and visionary personality who is interested in shaping the treatment of people suffering from a serious [. .. ] AI, IVA Strong commercial business acumen, strategic and innovative thinking Digital and analytical capabilities to analyze, transform data and feedback into insights Adhering to compliance, achieving and maintaining all applicable regulatory, legal and operational rules and procedures Strong communication skills in German English, both written and oral Commitment to our Core Values: Patients First, Thoughtfulness, Urgency, Trust, Optimism Why Blueprint? At Blueprint Medicines, we achieve impactful results because of our global crew of compassionate innovators the Blue Crew. Through authentic relationships [. .. ] problems, with a focus on allergy/ inflammation and oncology/ hematology. Our approach begins by targeting the root causes of disease, using deep scientific knowledge in our core focus areas and drug discovery expertise across multiple therapeutic modalities. We have a track record of success, leveraging our established research, development, and commercial capability and infrastructure, we aim to significantly scale our impact by advancing a broad pipeline of programs ranging from early science to advanced clinical trials in mast cell diseases and [. .. ]
Job vor 9 Tagen bei Jobleads gefunden
Clinical Oversight Manager (COM) - Germany
Clinical Oversight
Manager (COM) - Germany Join to apply for the Clinical Oversight Manager (COM) - Germany role at kps life The primary responsibility of the (Clinical) Oversight Manager [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] (C) OM) is to ensure adequate Sponsor oversight of the conduct, monitoring and management of one or more clinical studies and assigned monitors at [. .. ] management and monitoring. Ensures high quality conduct and execution of clinical studies at sites according to the protocol and study team and governance requirements in compliance with quality, regional and regulatory (GCP) standards. Addresses issues identified with study conduct, monitoring and site management with Sponsors management, are appropriately communicated/escalated and follows up through resolution. May conduct oversight monitoring visits, co-monitoring visits, monitoring visit report reviews and other Sponsor oversight activities per applicable study plans, as needed. Reviews the submission [. .. ] relevant clinical research (or related) experience. 6+ years experience in monitoring and site management of industry sponsored clinical research (CRA, Clinical Trial Monitor, or equivalent) . Thorough understanding of the drug development and clinical trial process. Ability to assess selected CROs monitoring performance and provide constructive feedback and remediation as necessary. Ability to participate in preparation, conduct and follow up of audits and site inspections. Active management experience of countries and sites in a region. Thorough knowledge of ICH guidelines/ GCP [. .. ]
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Häufig gestellte Fragen
Wieviel verdient man als Drug Regulatory Manager pro Jahr?
Als Drug Regulatory Manager verdient man zwischen EUR 60.000,- bis EUR 90.000,- im Jahr.
Wieviele offene Stellenangebote gibt es für Drug Regulatory Manager Jobs bei unserer Jobsuche?
Aktuell gibt es auf JobRobot 177 offene Stellenanzeigen für Drug Regulatory Manager Jobs.
Wieviele Unternehmen suchen nach Bewerbern für Drug Regulatory Manager Jobs?
Aktuell suchen 21 Unternehmen nach Bewerbern für Drug Regulatory Manager Jobs.
Welche Unternehmen suchen nach Bewerbern für Drug Regulatory Manager Stellenangebote?
Aktuell suchen zum Beispiel folgende Unternehmen nach Bewerbern für Drug Regulatory Manager Stellenangebote:
- Cpl Life Sciences (11 Jobs)
- Veeda Lifesciences (11 Jobs)
- wax. (11 Jobs)
- Tubulis GmbH (11 Jobs)
- Pfizer (2 Jobs)
- Discover International (2 Jobs)
In welchen Bundesländern werden die meisten Drug Regulatory Manager Jobs angeboten?
Die meisten Stellenanzeigen für Drug Regulatory Manager Jobs werden derzeit in Bayern (35 Jobs), Nordrhein-Westfalen (26 Jobs) und Baden-Württemberg (18 Jobs) angeboten.
Zu welchem Berufsfeld gehören Drug Regulatory Manager Jobs?
Drug Regulatory Manager Jobs gehören zum Berufsfeld Regulatory Affairs & Management.
