69 Jobs für Drug Regulatory Manager
Stellenangebote Drug Regulatory Manager Jobs
Job am 25.04.2026 bei Neuvoo.com gefunden
Disability Solutions
• Bavaria Penzberg
Führungs-/ Leitungspositionen
[. .. ] appropriately. Engage partners in face to face customer meetings at conferences, FMI and partner locations. Identify and establish relationships with precision medicine decision makers and influencers in [...]
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[...] all stages of drug and diagnostic development. Partnership Management Responsible and accountable for end-to-end management and growth of key Bio Pharma accounts, meeting OKRs linked to success of the Bio Pharma customer, planned timelines, and milestones. Responsible for managing profiling forecasting activities with external partners. Support cross-functional team members in Diagnostic Development, Regulatory, Bio Pharma, and other departments in managing partner relationships, including serving as a point of escalation and leveraging governance bodies to advance partnership growth. Accountable for partner satisfaction and account health through sustained engagement, AHC survey, and continued feedback. Team Leadership Serve as a matrix manager and mentor to team members, including Alliance Management and Business Development colleagues. Travel domestically and internationally up to 30 of the time, in line with quarterly customer engagement expectations. Ability to flex work schedule to meet global customer needs Other duties as assigned. Qualifications: Basic Qualifications: Bachelors degree in a [. .. ]
Neu Job vor 4 Std. bei Mindmatch.ai gefunden
Amplity
Clinical Trial Liaison, Oncology
• AT- 9 Wien
Join Amplity, the full-service go-to partner of biopharma companies that delivers flexible + specialized medical + commercial services. No matter where a
drug is in its lifecycle, we scale with [...]
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[...] ease to maximize resources + improve impact for all our clients. Through strategic partnerships + deep therapeutic expertise, Amplity transforms how breakthrough treatments reach the people who need them. Business Unit Global Patient and Site Engagement (GPSE) Reports to Program Director, Amplity Health Location Home based anywhere in Germany or Austria Territory DACH, Israel, Turkey, 60 travel Therapeutic Areas Oncology and Neurology Individual or Manager Individual We are seeking an experienced Clinical Trial Liaison (CTL) to lead site engagement strategies and patient-focused initiatives. Join a dynamic team dedicated to improving operational excellence and inclusivity in clinical trials, while building strong relationships with healthcare providers and key opinion leaders (KOLs) . Key Responsibilities Develop peer-[. .. ] airport. Fluent in English and German. Preferred Solid tumor/ targeted therapy experience and a proven track record of success. Knowledge of healthcare environments and external experts in academia. Familiarity with regulatory requirements for field-based personnel. About Us Amplity powers biopharma innovation through expert-led teams that deliver. Whether you knew us in the 80s as Physician Detailing Inc. , or in the 00s as part of Publicis Health, the companies that came together in 2019 to form Amplity have delivered [. .. ]
Neu Job vor 4 Std. bei Mindmatch.ai gefunden
IQVIA LLC
• AT- 9 Wien
Clinical Associate
Regulatory Submissions, Austria, IQVIA Biotech page is loaded # # Clinical Associate Regulatory Submissions, Austria, IQVIA Biotechlocations: Vienna, Austriatime type: Full timeposted on: Posted Todayjob requisition id: R1522611 [...]
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[...] Clinical Associate Submissions Regulatory Homebased Austria IQVIA Biotech partners exclusively with biotech and emerging biopharma companies to support clinical development across all phases [. .. ] Functions As Regulatory Start-Up Specialist, you will work and lead complex projects under general supervision, serve as Single Point of Contact in assigned studies for investigative sites, Site Activation Manager, Project Management team, and other departments as necessary. You will also ensure adherence to standard operating procedures (SOPs) , Work Instructions, quality of designated deliverables and project timelines. You will prepare submission documents and submit to regulatory bodies. You will perform feasibility, site ID, start up and site activation activities [. .. ] and to effectively prioritize tasks. Ability to manage multiple projects. Knowledge and ability to apply GCP/ ICH and applicable regulatory guidelines. Understanding of regulated clinical trial environment and knowledge of drug development process. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at IQVIA [. .. ]
Job am 23.04.2026 bei Mindmatch.ai gefunden
Vesta, Inc.
Case Manager-SEVERN, MD
• AT- 4 Berg
[. .. ] clients in Maryland. We provide comprehensive behavioral healthcare services, including clinic facilities, day programs, and residential homes, to support individuals grappling with mental health disorders. Were currently [...]
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[...] seeking a Case Manager to join our Anne Arundel County Regions PRP program. In this vital role, youll provide crucial support through service coordination, outreach efforts, and sourcing additional resources for social, health, and medical needs. With a hands-on approach, youll ensure that clients achieve their goals, address somatic health concerns, and receive [. .. ] years of experience in Case Management Experience working with clients with mental health disorders Valid drivers license, reliable transportation, and willingness to transport clients Ability to pass background check and drug screening Responsibilities Provide supportive counseling and advocacy for clients Assist with client assessments and provide necessary information on various aspects of life Facilitate clients access to educational and job training opportunities Maintain accurate and complete case records in compliance with policy, procedure, and regulatory requirements Refer clients to appropriate services and support groups Conduct on and off-site meetings and groups with clients as required Act as a liaison for hospitalized clients and follow up on somatic care referrals Join us at Vesta, Inc. and be part of a team dedicated to making a [. .. ]
Job am 22.04.2026 bei Mindmatch.ai gefunden
Novartis
• AT- 7 Langkampfen
Role Purpose The Supply Chain
Manager (SCM) is responsible for Demand and Supply Planning from Clinical Finished Good (CFG) to
Drug Substance (DS) and Booklet labels, ensuring demand fulfillment for [...]
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[...] assigned projects. The SCM acts as a key contributor to the Clinical Supply Operations Planning (CS OP) process in TRd/GCS and provides transparency on supply constraints and manages related aspects accordingly within TRD. Summary Location: Schaftenau, Austria #onsite About [. .. ] supply strategy of CHAd/PHAd/Biologics. Participates in the GPMM along with the CSPL and CTSM ensuring alignment between demand and supply. Ensures demand fulfillment and coverage of supply and regulatory aspects by contributing to GCS agenda at TRD Sub team CMC meeting. Represents GCS at TRD Subteam on supply chain aspects. Actively contributes to the portfolio manufacturing schedule alignment (from DS to CFG) and defines most costefficient ordering levels from CFG to DS, minimizing waste and allowing flexibility to accommodate [. .. ]
Job am 14.04.2026 bei Mindmatch.ai gefunden
Vesta, Inc.
Case Manager, Lanham, MD
• AT- 4 Berg
[. .. ] clients in Maryland. We provide comprehensive behavioral healthcare services, including clinic facilities, day programs, and residential homes, to support individuals grappling with mental health disorders. Were currently [...]
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[...] seeking a Case Manager to join our Lanham Regions PRP program. In this vital role, youll provide crucial support through service coordination, outreach efforts, and sourcing additional resources for social, health, and medical needs. With a handson approach, youll ensure that clients achieve their goals, address somatic health concerns, and receive the necessary support [. .. ] years of experience in Case Management-Experience working with clients with mental health disorders-Valid drivers license, reliable transportation, and willingness to transport clients-Ability to pass background check and drug screening Responsibilities:-Provide supportive counseling and advocacy for clients-Assist with client assessments and provide necessary information on various aspects of life-Facilitate clients access to educational and job training opportunities-Maintain accurate and complete case records in compliance with policy, procedure, and regulatory requirements-Refer clients to appropriate services and support groups-Conduct on and offsite meetings and groups with clients as required-Act as a liaison for hospitalized clients and follow up on somatic care referrals Join us at Vesta, Inc. and be part of a team dedicated to making a meaningful [. .. ]
Job am 15.03.2026 bei Mindmatch.ai gefunden
Tetra Science
• AT- 9 Wien
[. .. ] to company and team building. If you join us, you will be expected to embody its contents each day. Who You Are Tetra Science is seeking an [...]
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[...] elite Technical Program Manager dedicated to a single, high-profile account in Vienna, Austria. In this role, you will drive urgency and focus across both Tetra Science and our customer partnereveryday matters as you lead a first-of-its-kind program to productize scientific data and use cases. You are a customer-obsessed leader [. .. ] end goal of leveraging AI/ ML for improved scientific outcomes. An understanding of how scientific data underpins AI/ ML model training and deployment. Working knowledge of Gx P compliance and related regulatory frameworks (e. g. , GMP, GLP) . Ability to distill and communicate complex technical and scientific information to audiences ranging from delivery teams to VP-and C-level stakeholders. Demonstrated capability to effectively engage in customer-facing leadership conversations, influencing outcomes and maintaining alignment with strategic objectives. 5+ years of [. .. ] how the worlds largest pharmaceutical companies will operate in the AI era. This is more than just program management; it is industrial transformation with the potential to accelerate life-saving drug development for billions of people. 100 employer-paid benefits for all eligible employees and immediate family members Unlimited paid time off (PTO) 401K Company paid Life Insurance, LTd/STD We are not currently providing visa sponsorship for this position J-18808-Ljbffr 84542439 [. .. ]
Job am 29.03.2026 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 [...]
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[...] Closely 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 vor 2 Tagen bei Jooble gefunden
Veeva Systems
• Berlin
Beratungs-/ Consultingtätigkeiten
[. .. ] consulting working together. We expect significant growth in Business Consulting as we look towards 2030, and are looking for great people to make it happen. The Role [...]
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[...] As an Engagement Manager in our R D Business Consulting practice, you will help customers bring treatments to patients faster by transforming how they work with Technology, Data, and AI. You will focus on reshaping operating models, driving organizational change, and measuring tangible business value. R D Business Consulting supports biopharma, medtech, animal and consumer health customers with solving business problems across the R D value chain but also specifically within Clinical, Pharmacovigilance and Regulatory domains. You will be part of a global team delivering meaningful and high-impact projects with a variety of organisations from Top 20 Pharma to small/ mid-sized organisations. What You ll Do Strategic Delivery: Act as the end-to-end lead on Veevas most complex, large-scale, and global [. .. ] Sciences Consulting (Business or Management Consulting preferred) Leadership: Proven track record of managing large project teams and 1M+ engagements Domain Knowledge: Proven expertise in Clinical Data/ Operations, Regulatory or Pharmacovigilance/ Drug Safety and the broader Life Sciences industry Mindset: A highly analytical approach to problem-solving with the ability to influence C-suite stakeholders Education: Bachelors degree or higher Nice to Have Deep knowledge of Veeva products Experience delivering Saa S or Tech-enabled consulting solutions The Process Our process is different [. .. ]
Job vor 2 Tagen bei Jooble gefunden
Senior CRA Germany Oncology
• Region München, Bayern; Regierungsbezirk Oberbayern; Bayern
Senior CRA Germany Oncology Syneos Health is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the
drug [...]
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[...] development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress. Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape. Whether you join us in [. .. ] are currently looking for a senior CRA to join the team. Performs site qualification, site initiation, interim monitoring, site management and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/ escalates serious issues to the project team and develops action plans. Maintains a working knowledge of [. .. ] off visits for junior CRA staff, as assigned. May be mentored and assigned clinical operations lead tasks under supervision of an experienced Clinical Operations Lead (COL) , or operational line manager. Qualifications: Bachelors degree or RN in a related field or equivalent combination of education, training and experience Experience as a CRA in oncology trials. Knowledge of Good Clinical Practice/ ICH Guidelines and other applicable regulatory requirements Must demonstrate good computer skills and be able to embrace new technologies Excellent communication, [. .. ]
Job vor 13 Tagen bei Jooble gefunden
Sartorius Corporate Administration GmbH
• Württemberg Regierungsbezirk Freiburg, DE
Abgeschlossenes Studium
Betriebliche Altersvorsorge 30+ Urlaubstage
Für den Bereich Quality suchen wir einen
Manager Quality Control (x w m) für die Sartorius Cell Genix Gmb H. In dieser Position übernehmen Sie die fachliche und disziplinarische [...]
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[...] Führung der Abteilung Quality Control. Sie definieren strategische Ziele, sichern deren Umsetzung und steuern Projekte ganzheitlich, einschließlich Budgetplanung und Kostenkontrolle. Die Qualitätskontrolle besteht aus 4 Teams mit insgesamt 23 Mitarbeitenden, [. .. ] uns-Ihre Aufgaben Sie führen und entwickeln Ihr Team und schaffen ein Umfeld, das Zusammenarbeit, Wissenstransfer und Eigenverantwortung stärkt Sicherstellung und Optimierung von Qualitätsfreigabeprozessen, Prüfstandards und Dokumentationen und Unterstützung des Regulatory Affairs-Bereichs bei der Erstellung von regulatorischen Dokumenten wie Drug Master Files Erfassen und Berichten von Kennzahlen (KPI, PI) für den Bereich Qualitätskontrolle Durchführung interner wie externer Audits sowie die Begleitung von Zertifizierungen Sie sind Ansprechpartner für qualitätsrelevante Kundenanfragen und koordinieren deren Bearbeitung Aktualisierte Qualitätsrichtlinien, Standards und Verfahrensanweisungen obliegen Ihnen und stellen sicher, dass interne wie externe Anforderungen jederzeit erfüllt [. .. ]
Job am 25.04.2026 bei Jooble gefunden
Bionorica
Drug Regulatory Affairs Manager (m/w/d)
• Landkreis Neumarkt in der Oberpfalz; Region Regensburg, Bayern; Regierungsbezirk Oberpfalz; Bayern Neumarkt in der Oberpfalz, DE
Flexible Arbeitszeiten Betriebliche Altersvorsorge
Drug Regulatory Affairs
Manager (m/w/d) Neumarkt Bionorica ist, mit ca. 2.200 Mitarbeitern weltweit, der deutsche Marktführer für apothekenpflichtige pflanzliche Arzneimittel. Seit über 85 Jahren entschlüsseln wir die Geheimnisse der [...]
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[...] Natur indem wir die Erkenntnisse der traditionellen Arzneipflanzen-Therapie mit den zukunftsweisenden Ergebnissen der naturwissenschaftlichen Forschung vereinen. Phytoneering heißt die Formel unseres [. .. ]
Job am 25.04.2026 bei Jooble gefunden
• Region München, Bayern; Regierungsbezirk Oberbayern; Bayern München, DE
Clinical Trial
Manager Syneos Health is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the
drug [...]
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[...] development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress. Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape. Whether you join us in [. .. ] for customers and defining the pace of patient progress. Job Responsibilities Responsible for site management oversight, clinical monitoring and central monitoring deliverables with a focus on patient safety, protocol/ GCP/ regulatory compliance and data integrity. Oversees site interactions post activation through site closeout. This may include patient recruitment, investigator payments or other related activities. May be responsible for identification of critical data and process, protocol execution risks and risk mitigations related to completion of the Risk Assessment and Categorization Tool (RACT) [. .. ]
Job am 24.04.2026 bei Jooble gefunden
Global Study Manager ( Project Manager) - Sponsor-dedicated, in EMEA
• Region München, Bayern; Regierungsbezirk Oberbayern; Bayern München, DE
Global Study
Manager ( Project Manager) - Sponsor-dedicated, in EMEA Syneos Health is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators [...]
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[...] at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress. Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape. Whether you join us in [. .. ] pace of patient progress. Job Responsibilities Project Leadership and Delivery. Manages a project as a project manager overseeing interdisciplinary clinical research studies and ensures compliance with GCP, relevant SOPs, and regulatory requirements. Acts as a primary liaison between the Company and the Customer to ensure timely study launch, conduct, and closeout according to the Customers and the Companys contractual agreement. Lead project team to ensure quality, timelines and budget management. Accountable for the financial performance of each project. Coordinate activities and [. .. ]
Job am 18.04.2026 bei Jooble gefunden
• Region München, Bayern; Regierungsbezirk Oberbayern; Bayern München, DE
Clinical Trial
Manager (Sponsor Dedicated) Homebased, Germany Syneos Health is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress. Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape. Whether you join us in [. .. ] join the team. Develop and coordinate Phase 1 clinical research studies, ensuring all aspects of the study are meticulously planned and executed Implement clinical research protocols and ensure compliance with regulatory requirements, including Good Clinical Practice (GCP) guidelines Collaborate with principal investigators, research subjects, client teams, and clinic operations teams to facilitate smooth communication and coordination Plan and manage logistics and resource usage for clinical trials, including scheduling, budgeting, and resource allocation Track study progress and ensure alignment with project milestones, [. .. ]
Job am 15.04.2026 bei Jooble gefunden
Sr CRA Oncology Germany
• Region München, Bayern; Regierungsbezirk Oberbayern; Bayern München, DE
Sr CRA Oncology Germany Syneos Health is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the
drug [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress. Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape. Whether you join us in [. .. ] for customers and defining the pace of patient progress. Job Responsibilities Performs site qualification, site initiation, interim monitoring, site management and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/ escalates serious issues to the project team and develops action plans. Maintains a working knowledge of [. .. ] off visits for junior CRA staff, as assigned. May be mentored and assigned clinical operations lead tasks under supervision of an experienced Clinical Operations Lead (COL) , or operational line manager. Qualifications: Bachelors degree or RN in a related field or equivalent combination of education, training and experience Knowledge of Good Clinical Practice/ ICH Guidelines and other applicable regulatory requirements Three years monitoring experience Experience in monitoring oncology trials Must demonstrate good computer skills and be able to embrace new technologies [. .. ]
Job am 08.04.2026 bei Jooble gefunden
ISG International Service Group
• Hamburg Hamburg, DE
Homeoffice möglich
Flexible Arbeitszeiten
Standort: Hamburg Für ein international erfolgreiches Pharmaunternehmen mit Schwerpunkt auf der Entwicklung generischer Arzneimittel suchen wir am Standort Hamburg eine erfahrene Persönlichkeit im Bereich
Drug Development und CMC-Management. Das [...]
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[...] wird Ihnen geboten Unbefristete Festanstellung in einem wirtschaftlich stabilen Pharmaunternehmen Verantwortungsvolle Senior-Position im Bereich Pharmaentwicklung CMC Internationale Projektverantwortung im Generika-Umfeld Flache Hierarchien und kurze Entscheidungswege Flexible Arbeitszeiten und Homeoffice-Option Weiterbildungs- und Entwicklungsmöglichkeiten Attraktives Gehaltspaket inklusive Zusatzleistungen Ihre Verantwortung (Pharmaentwicklung CMC) Sie steuern [. .. ] Arzneimittel von der Strategie bis zur Markteinführung und agieren als Schnittstelle zwischen internen Teams und externen Partnern. Entwicklung und Umsetzung von CMC-Strategien für Drug Products Koordination interdisziplinärer Teams (Entwicklung, Regulatory Affairs, Einkauf, Qualität) Auswahl und Steuerung internationaler API- und FDF-Partner Bewertung von ASMF-, CMC- und Zulassungsdokumentationen Unterstützung internationaler Zulassungsverfahren (EU, FDA) Bearbeitung regulatorischer Rückfragen (Deficiency Letters) Technische Unterstützung bei Due-Diligence-Prozessen Ihr Profil Studium: Pharmazie, Chemie oder vergleichbar Mehrjährige Erfahrung in der pharmazeutischen Entwicklung (idealerweise Generika) Kenntnisse [. .. ]
Job am 08.04.2026 bei Jooble gefunden
HARMAN International
Software Architect, Connectivity (m/f/d)
• Region Donau- Iller, Württemberg; Regierungsbezirk Tübingen; Württemberg Ulm, DE
Work-Life-Balance
[. .. ] and address architecturally relevant non-functional requirements Ensure traceability and consistency with the system architecture and the software requirements Recommend implementation standards and design patterns that support information [...]
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[...] security and regulatory compliance objectives Document key technical requirements for our Telematic Software Customer contact for identifying and understanding architectural requirements Contribute to the Cybersecurity project efforts Support the Cybersecurity Manager in developing different technical work products Represent the project for Threat Analysis and Risk Assessment (TARA) Make risk treatment decisions Derive security requirements from TARA, and maintain the requirements specification for the cybersecurity concept Support RFI/ RFQ response on cybersecurity activities What You Need Master s or Bachelor s degree [. .. ] necessities Be willing to work in an office, with hybrid model of remote and onsite office in one of our major software development sites Successfully complete a background investigation and drug screen as a condition of employment What We Offer HARMAN offers a diverse and inclusive work environment that fosters and encourages career development opportunities, professional training and competitive market base compensation You will also receive top-notch employee discounts on Harmans Consumer Audio (JBL, AKG, HARMAN Kardon) and Samsung products [. .. ]
Job am 08.04.2026 bei Jooble gefunden
IQVIA
• Regierungsbezirk Darmstadt; Hessen Frankfurt am Main, DE
Führungs-/ Leitungspositionen
The Sr. CDM will lead and contribute to data management activities in support of Client s studies across all stages of clinical
drug development. Summary of Key Responsibilities Contribute [...]
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[...] to data management activities as a lead study data manager in support of Client s clinical studies Lead database build activities including leading cross-functional review of e CRF content, review of edit check specifications, and perform user acceptance testing Monitor data collection, coding, and cleaning by vendors through tracking of study metrics and targeted data reviews Oversight of database lock activities and ultimate archiving of study data Collaborate with internal and external partners, including Biostatistics, Statistical Programming, Clinical Operations, Medical, Quality Assurance, Global Patient Safety and Risk Management, and Regulatory Affairs; CROs, central and local laboratories, and other vendors Establish cross-functional, internal data review plans, coordinate data cuts/ transfers, and conduct data reviews Review CRO data management plans, CRF completion guidelines, external data transfer specifications and other study documentation Contribute to development and implementation of department workflows and infrastructure [. .. ]
Job am 08.04.2026 bei Jooble gefunden
Manufacturing and Supply Where the miracles of science are made a reality for patients
• Ausland China, DE
[. .. ] resume with your application. About the job Be part of a once-in-a-generation project thats shaping the future of insulin. Sanofi is building cutting-edge, fully automated insulin
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[...] class=highlight_text>drug substance facilities in Frankfurt and Beijing a bold investment that builds on our legacy of excellence in insulin manufacturing. This sustainable, next-gen biologics sites will support the entire portfolio of insulins. Join us at the forefront of this global transformation. As part of a cross-functional program team, youll [. .. ] reality for millions living with diabetes. Meet Katrin, our Global Insulin Program Leader, and see how were reimagining insulin production. Watch now We are seeking a highly skilled and experienced
Regulatory Site Officer for our Insu LINK program. This senior leadership position is vital in ensuring the highest standards of regulatory compliance throughout our state-of-the-art insulin manufacturing facilities in Europe and China. The role involves leading all quality regulatory activities (RSO) for both sites, with a focus on regulatory [. .. ] delivery of all quality regulatory affairs aspects within allocated budget, schedule, and quality objectives while providing regular reporting to the Global Program Quality Head Insu LINK and dotted line reporting to
Manager Regulatory CMC. Ensure compliance of Insu LINK insulin API products with all relevant product registrations, laws, regulations, standards, and guidelines in markets where IFF (Germany) and IFB (China) sites are licensed. Author and manage CTD dossiers, variations, renewals, and all technical regulatory documentation for Insu LINK product registrations in compliance with applicable [. .. ]
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Job am 08.04.2026 bei Jooble gefunden
Infosys Consulting- Europe
Sr. Principal Consultant, Regulatory Strategy and Advisory
• Region München, Bayern; Regierungsbezirk Oberbayern; Bayern München, DE
Beratungs-/ Consultingtätigkeiten
[. .. ] with our clients. Additional skills that are highly desirable include value realization, process re-engineering, design thinking and agile delivery experienced Role Summary, Core Expectations In depth knowledge [...]
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[...] of Pharma Regulatory Operations and Regulatory IT Systems aligned to core Functional and Technical competencies Expert in Regulatory and Clinical area with ability to drive futuristic IT solutions and experience in client facing and agency thought leadership. Understanding and knowledge of processes related to health authority submissions, content authoring, labeling, lifecycle management of [. .. ] trends, needs and business requirements expected from clients Able to strategize and advise on the product roadmap and should work closely with the client in delivering solutions. An empathic people manager responsible to mentor and guide a team for progressive outcomes Technical Credentials: Should have masters degree in a Life Science, Medical or Related discipline. Masters in Business Administration would be an added advantage. Minimum 12-15 years experience in Drug development, Regulatory, Clinical Operation and Medical Devices. Deep understanding of RIM systems i. e. , Veeva Vault, PARAXEL/ LIQUENT In Sight, CSC Regulatory Tracker, Aris Global Register, Open Text, Share Point, Documentum, First Doc/ First Point, Next Docs, CARA, Extedo e CTD Manager, Trackwise, or other regulatory information management systems Submission [. .. ]
Job am 08.04.2026 bei Jooble gefunden
Veeva Systems
Engagement Manager-R D (Remote)
• Berlin Berlin, DE
[. .. ] our leading R D consulting practice is a strategic priority for Veeva, with high visibility within the company and to leaders of the wider Life Sciences industry. [...]
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[...] As an Engagement Manager, you will manage complex and novel consulting projects for Veeva customers in the research and development (R D) space managing teams and planning, organizing, and tracking all aspects of delivery. You will support building our brand in the market, developing our customer network, and identifying and acquiring new projects to support our customers to deliver on their complex business challenges. As part of the team, you will focus on one or more critical areas such as Clinical Development, Regulatory Affairs, Pharmacovigilance/ Drug Safety, and Quality Management. What You ll Do Lead multiple project engagement teams empowering the team to plan and manage all aspects of delivery, from scope to quality assurance Be responsible for the end-to-end design, build, and delivery of deliverables that meet overall project goals and objectives Proactively [. .. ]
Job am 08.04.2026 bei Jooble gefunden
Local Clinical Trial Manager-Single Sponsor
• Region München, Bayern; Regierungsbezirk Oberbayern; Bayern München, DE
Local Clinical Trial
Manager-Single Sponsor Syneos Health is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the [...]
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[...] drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress. Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape. Whether you join us in [. .. ] we are looking for CTM to cover phase II/ III trials. Responsible for site management oversight, clinical monitoring and central monitoring deliverables with a focus on patient safety, protocol/ GCP/ regulatory compliance and data integrity. Oversees site interactions post activation through site closeout. This may include patient recruitment, investigator payments or other related activities. May be responsible for identification of critical data and process, protocol execution risks and risk mitigations related to completion of the Risk Assessment and Categorization Tool (RACT) [. .. ]
Job gestern bei Jobleads gefunden
Clinical Trial Associate (6-Month Contract)
• Zug
[. .. ] wholly-owned U. S. subsidiary, CRISPR Therapeutics, Inc. , and R D operations based in Boston, Massachusetts and San Francisco, California Position Summary Working closely with the Associate [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] Clinical Trial Manager and Clinical Operations Team, the Clinical Trial Associate (CTA) contract position will assist with daily clinical trial execution activities including the coordination of documents associated with the conduct of investigational clinical studies in accordance with applicable regulations, Good Clinical Practice (GCP) , and CRISPR Therapeutics standard operating procedures (SOPs) . [. .. ] orders in financial system Coordinate version control of clinical documents, prioritize multiple tasks and/or projects Assist in coordination and tracking of clinical supply shipments, including review and approval of Regulatory Documentation Packages Support Clinical Operations team with specific projects Effectively communicate with study team members and work closely to address challenges Minimum Qualifications BS/ BA degree or equivalent and at least 1-3 years experience in clinical operations in Sponsor company Knowledge of drug development, clinical operation processes and documentation including study start up procedures, maintenance phase, and study close out procedures Knowledge and implementation of the processes involved in clinical studies following Good Clinical Practice (GCP) and the Code of Federal Regulations Experience with e TMF; ability to directly apply essential document knowledge to [. .. ]
Job vor 2 Tagen bei Jobleads gefunden
Regulatory Affairs Manager
• Basel, Basel- Stadt
EU Senior Global
Regulatory Affairs Project Leader (m/w/d) The Role Drive EU regulatory strategy and lifecycle management for innovative medicinal products. You will serve as the primary strategic lead [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] and interface with the EMA and National Competent Authorities to ensure rapid, compliant market access. Key Responsibilities Strategy Interface: Define EU regulatory pathways and lead all formal interactions with the EMA and NCAs. Submissions: Oversee the end-to-end delivery of IMPDs, PIPs, Orphan Drug Applications, MAAs, and variations. Scientific Advice: Lead the preparation and execution of regulatory meetings and briefing packages. Compliance Labeling: Ensure EU labeling aligns with the Company Core Data Sheet (CCDS) and regional requirements. Global Leadership: (When applicable) Own global regulatory functional plans, maintain the CCDS, and lead crossfunctional regulatory subteams. [. .. ]
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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.
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Wieviele Unternehmen suchen nach Bewerbern für Drug Regulatory Manager Jobs?
Aktuell suchen 15 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:
- Veeva Systems (2 Jobs)
- Pro Pharma Group (2 Jobs)
- Disability Solutions (1 Job)
- Amplity (1 Job)
- IQVIA LLC (1 Job)
In welchen Bundesländern werden die meisten Drug Regulatory Manager Jobs angeboten?
Die meisten Stellenanzeigen für Drug Regulatory Manager Jobs werden derzeit in Bayern (20 Jobs), Baden-Württemberg (8 Jobs) und Hamburg (5 Jobs) angeboten.
Zu welchem Berufsfeld gehören Drug Regulatory Manager Jobs?
Drug Regulatory Manager Jobs gehören zum Berufsfeld Regulatory Affairs & Management.
