92 Jobs für Drug Regulatory Affairs
Stellenangebote Drug Regulatory Affairs Jobs
Job am 15.04.2026 bei Neuvoo.com gefunden
Hochschule Kaiserslautern University of Applied Sciences
• Rhineland- Palatinate Pirmasens
[. .. ] für die Herstellung benötigt die Pharmaindustrie qualifiziertes, pharmazeutisches Personal. Die Haupttätigkeitsfelder eines Industriepharmazeuten können somit den folgenden Bereichen zugeordnet werden:Arzneimittelherstellung-Manufacturing Science Technology Forschung und Entwicklung-Research and Development [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] Arzneimittelzulassung-Drug Regulatory Affairs Arzneimittelsicherheit-Drug Safety Qualitätsmanagement-Quality Management Ein Studium der Industriepharmazie eröffnet den Absolventinnen und Absolventen die Möglichkeit, in all den verschiedenen pharmazeutischen sowie verwandten Bereichen wie z. B. in der Kosmetik oder Nahrungsmittelindustrie zu arbeiten. Alternativ kann im Anschluss die erworbene Expertise durch ein Masterstudium erweitert werden, etwa mit einem [. .. ]
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 Natur [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] indem wir die Erkenntnisse der traditionellen Arzneipflanzen-Therapie mit den zukunftsweisenden Ergebnissen der naturwissenschaftlichen Forschung vereinen. Phytoneering heißt die Formel [. .. ]
Job vor 5 Tagen bei Jobleads gefunden
• Grenzach, Baden- Württemberg
Führungs-/ Leitungspositionen Abgeschlossenes Studium
Die Position Als Head of
Drug Regulatory Affairs (d/f/m) gestaltest Du die Brücke zwischen pharmazeutischer Entwicklung und der sicheren Versorgung von Patient:innen, indem Du die Konformität unseres Portfolios in einem [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] dynamischen regulatorischen Umfeld sicherstellst. In dieser Schlüsselposition verbindest Du strategisches Handeln mit wissenschaftlicher Präzision, damit unsere Medikamente unter Einhaltung höchster Standards die Menschen erreichen, die sie [. .. ]
Job vor 5 Tagen bei Jobleads gefunden
Head of Drug Regulatory Affairs (m/w/d)
• Grenzach- Wyhlen, Baden- Württemberg
Führungs-/ Leitungspositionen Abgeschlossenes Studium
Kopfbereich Angebotsart: Arbeit Arbeitgeber: Roche Diagnostics Gmb H Beginn ab 01.07.2026 Anstellungsart: Vollzeit Befristung: unbefristet Berufsbezeichnung: Head of
Drug Regulatory Affairs (d/f/m) Stellenbeschreibung Als Head of Drug Regulatory Affairs (d/f/m) [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] gestaltest Du die Brücke zwischen pharmazeutischer Entwicklung und der sicheren Versorgung von Patient:innen, indem Du die Konformität unseres Portfolios in einem dynamischen regulatorischen Umfeld sicherstellst. In dieser Schlüsselposition verbindest Du strategisches Handeln mit wissenschaftlicher Präzision, damit unsere [. .. ]
Job am 05.04.2026 bei Jobleads gefunden
• Aachen, Nordrhein- Westfalen
[. .. ] Entwicklung und Umsetzung regulatorischer Strategien im Hinblick auf die Unternehmensziele Leitung der Pflege von IB, PBRER, DSUR, CCDS und anderen Dokumenten SOP-Management Qualifikation Mindestens 5 Jahre Erfahrung [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] im Bereich (Drug) Regulatory Affairs Kenntnisse des EU-Regulierungsrahmens Regulatorisches Lebenszyklusmanagement im Hinblick auf geschäftliche Anforderungen (CP, DCP, MRP, NP) Idealerweise Kenntnisse der EU-Verordnung (CTR) 536/ 2014 und mit CTIS Fähigkeit zur Zusammenarbeit mit internen Abteilungen und externen Partnern Englisch fließend, Deutsch von Vorteil Ihr Kontakt Für detailliertere Informationen zum Unternehmen, der Position und [. .. ]
Job am 05.03.2026 bei Jobleads gefunden
Regional Regulatory Lead GI Inflammation (EUCAN)
• Zürich
Führungs-/ Leitungspositionen
[. .. ] Zurich, Switzerland. This role involves leading regional regulatory strategies for assigned assets, ensuring timely submissions and approvals throughout product development. The ideal candidate will have at least [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] eight years of drug regulatory affairs experience and the ability to manage complex regulatory issues. Excellent communication skills and a collaborative approach are essential for success in this position. #J-18808-Ljbffr 82940632 [. .. ]
Job am 05.03.2026 bei Jobleads gefunden
• Zürich
Führungs-/ Leitungspositionen
[. .. ] Lead or support preparation activities for meetings with Health Authorities. Education, Competencies Skills BSc. Advanced scientific related degree preferred; BA accepted based on experience. Minimum eight years [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] of experience in drug regulatory affairs, preferably within the EU/ GEM region. Solid regulatory experience, including knowledge of regulations and guidance applicable in the region across all phases of development and ability to orient project teams in the interpretation of guidelines. An understanding of basic regulatory requirements in other regions globally (US, EU, emerging markets) is [. .. ]
Job vor 2 Tagen bei Mindmatch.ai gefunden
Jazz Pharmaceuticals
Senior Director, Biostatistics
• München Muenchen
Führungs-/ Leitungspositionen
[. .. ] headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit for more information. Brief [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] Description: The Medical Affairs and Value Statistics (MAVS) team at Jazz is a pivotal part of the Evidence and Value Generation function. This team partners with Medical Affairs and HEOR to design best-in-class studies and analyses to further characterize safety, efficacy, and effectiveness of our products to the medical, payer and patient [. .. ] to both the Global Medical Affairs community and the HEOR community. They will represent Jazz as an internal and external stakeholder in various forums and conferences and may interact with regulatory agencies on matters related to Jazzs products. The Senior Director will be asked to think outside the box to innovate, collaborate, and enhance the medical affairs and the value statistics organizations. Finally, they must commit to continuing to make Jazz a great place to work by delivering on our purpose [. .. ] Manage a team of biostatisticians Work with the Evidence and Value Generation leadership team and MAVS team members to develop, implement, and maintain department standards and practices Provide statistical and drug development expertise in collaboration with researchers and thought leaders, in the planning of the IEGP, and the studies that support them Support statisticians in ensuring timely delivery of quality analysis results using internal resources and CRO vendors Attend clinical meetings to present data supporting our products, learn other relevant analytical [. .. ]
Neu Job vor 4 Std. bei Mindmatch.ai gefunden
Jazz Pharmaceuticals
• Karlsfeld, BY
Führungs-/ Leitungspositionen
[. .. ] headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit for more information. Brief [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] Description: The Medical Affairs and Value Statistics (MAVS) team at Jazz is a pivotal part of the Evidence and Value Generation function. This team partners with Medical Affairs and HEOR to design best-in-class studies and analyses to further characterize safety, efficacy, and effectiveness of our products to the medical, payer and patient [. .. ] to both the Global Medical Affairs community and the HEOR community. They will represent Jazz as an internal and external stakeholder in various forums and conferences and may interact with regulatory agencies on matters related to Jazzs products. The Senior Director will be asked to think outside the box to innovate, collaborate, and enhance the medical affairs and the value statistics organizations. Finally, they must commit to continuing to make Jazz a great place to work by delivering on our purpose [. .. ] Manage a team of biostatisticians Work with the Evidence and Value Generation leadership team and MAVS team members to develop, implement, and maintain department standards and practices Provide statistical and drug development expertise in collaboration with researchers and thought leaders, in the planning of the IEGP, and the studies that support them Support statisticians in ensuring timely delivery of quality analysis results using internal resources and CRO vendors Attend clinical meetings to present data supporting our products, learn other relevant analytical [. .. ]
Job gestern bei Mindmatch.ai gefunden
Jazz Pharmaceuticals
Senior Director, Biostatistics
• Unterföhring, BY Unterfoehring
Führungs-/ Leitungspositionen
[. .. ] headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit for more information. Brief [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] Description: The Medical Affairs and Value Statistics (MAVS) team at Jazz is a pivotal part of the Evidence and Value Generation function. This team partners with Medical Affairs and HEOR to design best-in-class studies and analyses to further characterize safety, efficacy, and effectiveness of our products to the medical, payer and patient [. .. ] to both the Global Medical Affairs community and the HEOR community. They will represent Jazz as an internal and external stakeholder in various forums and conferences and may interact with regulatory agencies on matters related to Jazzs products. The Senior Director will be asked to think outside the box to innovate, collaborate, and enhance the medical affairs and the value statistics organizations. Finally, they must commit to continuing to make Jazz a great place to work by delivering on our purpose [. .. ] Manage a team of biostatisticians Work with the Evidence and Value Generation leadership team and MAVS team members to develop, implement, and maintain department standards and practices Provide statistical and drug development expertise in collaboration with researchers and thought leaders, in the planning of the IEGP, and the studies that support them Support statisticians in ensuring timely delivery of quality analysis results using internal resources and CRO vendors Attend clinical meetings to present data supporting our products, learn other relevant analytical [. .. ]
Job vor 2 Tagen bei Neuvoo.com gefunden
Jazz Pharmaceuticals
Senior Director, Biostatistics
• Bavaria Munich
Führungs-/ Leitungspositionen
[. .. ] headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit for more information. Brief [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] Description: The Medical Affairs and Value Statistics (MAVS) team at Jazz is a pivotal part of the Evidence and Value Generation function. This team partners with Medical Affairs and HEOR to design best-in-class studies and analyses to further characterize safety, efficacy, and effectiveness of our products to the medical, payer and patient [. .. ] to both the Global Medical Affairs community and the HEOR community. They will represent Jazz as an internal and external stakeholder in various forums and conferences and may interact with regulatory agencies on matters related to Jazzs products. The Senior Director will be asked to think outside the box to innovate, collaborate, and enhance the medical affairs and the value statistics organizations. Finally, they must commit to continuing to make Jazz a great place to work by delivering on our purpose [. .. ] Manage a team of biostatisticians Work with the Evidence and Value Generation leadership team and MAVS team members to develop, implement, and maintain department standards and practices Provide statistical and drug development expertise in collaboration with researchers and thought leaders, in the planning of the IEGP, and the studies that support them Support statisticians in ensuring timely delivery of quality analysis results using internal resources and CRO vendors Attend clinical meetings to present data supporting our products, learn other relevant analytical [. .. ]
Job vor 6 Tagen bei JobMESH gefunden
Jazz Pharmaceuticals
Senior Director, Biostatistics-Vollzeit
• Bavaria Munich
Führungs-/ Leitungspositionen
[. .. ] headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit for more information. Brief [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] Description: The Medical Affairs and Value Statistics (MAVS) team at Jazz is a pivotal part of the Evidence and Value Generation function. This team partners with Medical Affairs and HEOR to design best-in-class studies and analyses to further characterize safety, efficacy, and effectiveness of our products to the medical, payer and patient [. .. ] to both the Global Medical Affairs community and the HEOR community. They will represent Jazz as an internal and external stakeholder in various forums and conferences and may interact with regulatory agencies on matters related to Jazz s products. The Senior Director will be asked to think outside the box to innovate, collaborate, and enhance the medical affairs and the value statistics organizations. Finally, they must commit to continuing to make Jazz a great place to work by delivering on our [. .. ] Manage a team of biostatisticians Work with the Evidence and Value Generation leadership team and MAVS team members to develop, implement, and maintain department standards and practices Provide statistical and drug development expertise in collaboration with researchers and thought leaders, in the planning of the IEGP, and the studies that support them Support statisticians in ensuring timely delivery of quality analysis results using internal resources and CRO vendors Attend clinical meetings to present data supporting our products, learn other relevant analytical [. .. ]
Job vor 5 Tagen bei Stellen-Online.de gefunden
Berlin Institute of Health (BIH)
• Berlin, 10115, 10178
Teilzeit Homeoffice möglich
[. .. ] d) in full-time or part-time (min. 30h/ week) limited until 28.02.2029, starting as soon as possible. This position is funded by the ERC Starting Grant Gen
MEHR INFOS ZUM STELLENANGEBOT
[...] class=highlight_text>Drug, which aims to integrate large-scale genomic and real-world clinical data to discover new drug targets. We are seeking a dedicated and rigorous researcher with a demonstrable track record in population-level multi-omics analysis, statistical genomics, and pharmacoepidemiology. The successful candidate will lead the development and publication of [. .. ] Prof. Dr. Maik Pietzner (Email: maik. pietznerbih-charite. de) . For questions regarding the application process, please contact Biologie Biomedizin Postdoc Wissenschaftlicher Mitarbeiter, wissenschaftliche Mitarbeiterin Lehre Forschung, Wissenschaft Klinische Forschung,
Regulatory Affairs Medizin, Heilkunde Forschungseinrichtung Teilzeit Vollzeit-gefunden bei stellenonline. de 90657850 [. .. ]
▶ Zur Stellenanzeige
Job am 04.04.2026 bei Mindmatch.ai gefunden
Octapharma
Senior Global Medical Advisor (m/w/d) - temporary
• AT- 9 Wien
Senior Global Medical Advisor (m/w/d) - temporary Job ID: 62961 Location: Wien, AT Job Level: Professionals Job Category: Medical
Affairs Employment Type: Temporary employment This position is temporary until [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] 30.04.2028. Become part of a vital chain and contribute to our common goal of making peoples lives better. Octapharma is one of the largest human protein manufacturers in the world, developing and producing medicines sourced from human plasma and [. .. ] Responsible for project management of phase IV programs Your expertise and ideal skill set Completed academic degree, ideally in a medical or scientific background (MD or Ph D) Experience in critical care, regulatory, clinical development or drug safety would be an advantage Advanced skills in scientific writing and researching in medical databases Fluent English, additional languages beneficial Excellent organizational skills Strong interpersonal communication skills Readiness to travel Your department where you make an impact We, the GMSA, turn scientific knowledge into meaningful impact by bridging clinical research [. .. ]
Neu Job vor 4 Std. bei Jobleads gefunden
Senior Director, Biostatistics
• Wien
Führungs-/ Leitungspositionen
[. .. ] Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit for more [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] information. The Medical Affairs and Value Statistics (MAVS) team at Jazz is a pivotal part of the Evidence and Value Generation function. This team partners with Medical Affairs and HEOR to design best-in-class studies and analyses to further characterize safety, efficacy, and effectiveness of our products to the medical, payer and patient [. .. ] to both the Global Medical Affairs community and the HEOR community. They will represent Jazz as an internal and external stakeholder in various forums and conferences and may interact with regulatory agencies on matters related to Jazzs products. The Senior Director will be asked to think outside the box to innovate, collaborate, and enhance the medical affairs and the value statistics organizations. Finally, they must commit to continuing to make Jazz a great place to work by delivering on our purpose [. .. ] Manage a team of biostatisticians Work with the Evidence and Value Generation leadership team and MAVS team members to develop, implement, and maintain department standards and practices Provide statistical and drug development expertise in collaboration with researchers and thought leaders, in the planning of the IEGP, and the studies that support them Support statisticians in ensuring timely delivery of quality analysis results using internal resources and CRO vendors Attend clinical meetings to present data supporting our products, learn other relevant analytical [. .. ]
Job vor 3 Tagen bei Jobleads gefunden
Senior Director, Biostatistics
• München, Bayern
Führungs-/ Leitungspositionen
Brief Description The Medical
Affairs and Value Statistics (MAVS) team at Jazz is a pivotal part of the Evidence and Value Generation function. This team partners with Medical Affairs [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] and HEOR to design best-in-class studies and analyses to further characterize safety, efficacy, and effectiveness of our products to the medical, payer and patient [. .. ] to both the Global Medical Affairs community and the HEOR community. They will represent Jazz as an internal and external stakeholder in various forums and conferences and may interact with regulatory agencies on matters related to Jazzs products. The Senior Director will be asked to think outside the box to innovate, collaborate, and enhance the medical affairs and the value statistics organizations. Finally, they must commit to continuing to make Jazz a great place to work by delivering on our purpose [. .. ] Manage a team of biostatisticians Work with the Evidence and Value Generation leadership team and MAVS team members to develop, implement, and maintain department standards and practices Provide statistical and drug development expertise in collaboration with researchers and thought leaders, in the planning of the IEGP, and the studies that support them Support statisticians in ensuring timely delivery of quality analysis results using internal resources and CRO vendors Attend clinical meetings to present data supporting our products, learn other relevant analytical [. .. ]
Job am 14.02.2026 bei Jobleads gefunden
• Ulm, Baden- Württemberg
Führungs-/ Leitungspositionen
[. .. ] asset. Provides guidance, direction and oversight for the scientific/ medical leadership and partnership for late-stage development compounds and commercialized products. In partnership with head of neuroscience, represents [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] Global Medical Affairs in strategic discussions regarding medical launch preparation, lifecycle management, business development, clinical research, and health economics and outcomes research planning. Acts as a strategic partner for business and clinical development. Develops AOP, LRP and manages budget effectively and proactively. Your experience and qualifications KNOWLEDGE: MD and specialty training and clinical, [. .. ] years pharmaceutical industry experience. Pharmaceutical industry experience in neurology. Experience in successfully developing strategy and executing medical plans, and in building professional external expert networks. Broad and good knowledge of drug development, clinical trial design, regulatory requirements, business development and life cycle management etc. SKILLS/ QUALIFICATIONS: Able to work in a changing and flexible environment with a strong patient focus and enterprise mindset. Experienced and adept at working collaboratively across different cross-functional teams such as commercial, R D, health outcomes, regulatory, pharmacovigilance and compliance and [. .. ]
Job vor 4 Tagen bei Jooble gefunden
Jazz Pharmaceuticals
Senior Director, Biostatistics
• Region München, Bayern; Regierungsbezirk Oberbayern; Bayern
Führungs-/ Leitungspositionen
[. .. ] headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit for more information. Brief [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] Description: The Medical Affairs and Value Statistics (MAVS) team at Jazz is a pivotal part of the Evidence and Value Generation function. This team partners with Medical Affairs and HEOR to design best-in-class studies and analyses to further characterize safety, efficacy, and effectiveness of our products to the medical, payer and patient [. .. ] to both the Global Medical Affairs community and the HEOR community. They will represent Jazz as an internal and external stakeholder in various forums and conferences and may interact with regulatory agencies on matters related to Jazzs products. The Senior Director will be asked to think outside the box to innovate, collaborate, and enhance the medical affairs and the value statistics organizations. Finally, they must commit to continuing to make Jazz a great place to work by delivering on our purpose [. .. ] Manage a team of biostatisticians Work with the Evidence and Value Generation leadership team and MAVS team members to develop, implement, and maintain department standards and practices Provide statistical and drug development expertise in collaboration with researchers and thought leaders, in the planning of the IEGP, and the studies that support them Support statisticians in ensuring timely delivery of quality analysis results using internal resources and CRO vendors Attend clinical meetings to present data supporting our products, learn other relevant analytical [. .. ]
Job vor 13 Tagen bei Jooble gefunden
Sartorius Corporate Administration GmbH
• Württemberg Regierungsbezirk Freiburg, DE
Abgeschlossenes Studium
Betriebliche Altersvorsorge 30+ Urlaubstage
[. .. ] 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 [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] 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 16.04.2026 bei Jooble gefunden
Abb Vie
Analytical Lead-Protein Analytics in Early Analytical Development R D (all genders) (full-or parttime, permanent)
• Regierungsbezirk Rheinhessen- Pfalz; Rheinland- Pfalz Ludwigshafen am Rhein, DE
Teilzeit
Work-Life-Balance
[. .. ] Protein Analytics in Early Analytical Development R D (all genders) Abb Vie is seeking a seasoned analytical scientist with expert experience in the quality control strategy and [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] characterization of biological drug products to serve as Analytical Lead on global Product Development Strategy Teams that are charged with the pharmaceutical development of pipeline biological drug products. The incumbent will represent the analytical function and serve as single point of contact for the CMC Product Development Director (Product Development Strategy Team leader) and external partners for all analytical topics and will work closely with cross-functional subject matter experts from formulation, manufacturing process and device development, Quality Assurance and CMC Regulatory Affairs. Experience with late-stage development products and/or product CMC life cycle management is highly advantageous. Your tasks and responsibilities: You represent the Early Bio CMC Analytical Function as single point of contact in global Product Development Strategy Teams and are responsible for the analytical development and analytical control strategy [. .. ]
Job am 08.04.2026 bei Jooble gefunden
ISG International Service Group
Senior Manager Drug Development CMC-Generika (m/w/d)
• 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 [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] 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 EU-[. .. ]
Job am 08.04.2026 bei Jooble gefunden
Abb Vie
Biologics Drug Product Lead (R D) (all genders) (full-time, permanent)
• Regierungsbezirk Rheinhessen- Pfalz; Rheinland- Pfalz Ludwigshafen am Rhein, DE
Führungs-/ Leitungspositionen
Work-Life-Balance
[. .. ] a challenging work environment that offers opportunities of developing and increasing your own skills? Youve come to the right place Moving mountains together as Principal Research Scientist [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] I/ II/ Biologics Drug Product Lead (R D) (all genders) (full-time, permanent) Within R D Biologics Drug Product Development Germany, the Early Strategic and Technical Development group is seeking an experienced scientist with expert knowledge in Biologics drug product development who aims at taking a lead in developing innovative and patient centric Biological [. .. ] quality risk management and analytical development. Solid experience with various molecule types, working in a global team and strategic as well as scientific thinking is a must. Experience with CMC regulatory submission documents and working in a GMP regulated environment is required. Experience working in a matrix leadership is beneficial, as well as analytical experience in e. g. quality control and characterization of biological drug products, and knowledge in device development. . Your tasks and responsibilities The candidate will serve as [. .. ] Development Strategy Team leader) for all Drug Product Development topics and will work closely with cross-functional subject matter experts from Discovery, analytical, and device development, Quality Assurance, CMC Regulatory Affairs, parental Product Development Science Technology (Operations) and external partners You represent Biologics Drug Product Development Germany as single point of contact in global Product Development Strategy Teams and are responsible for the formulation, manufacturing process and container closure system development of early-stage biological assets up to clinical phase III. [. .. ]
Job am 08.04.2026 bei Jooble gefunden
IQVIA
Senior Clinical Data Team Lead (Senior DTL) - FSP
• 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 [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] 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 [. .. ] 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 strategy [. .. ]
Job am 08.04.2026 bei Jooble gefunden
Biontech
Director Statistical Programming (Oncology)
• Region München, Bayern; Regierungsbezirk Oberbayern; Bayern München, DE
Führungs-/ Leitungspositionen
[. .. ] programmers or vendor CROs to ensure timely, high-quality delivery of analysis datasets, tables, listings, and figures (TLFs) across multiple clinical trials Align programming strategies with compound/platform objectives [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] and regulatory requirements (e. g. , CDISC standards, FDA/ EMA guidelines) Drive the creation, review, and validation of SAS/ R programs for clinical data analysis, including SDTm/ADa M datasets, efficacy/ safety outputs, and integrated summaries Ensure adherence to SOPs, regulatory standards, and reproducibility Partner with Biostatistics, Clinical Development, Data Management, and Regulatory Affairs to shape clinical study designs, statistical analysis plans (SAPs) , and submission strategies to meet project deliverables and timelines for statistical data analysis and reporting Represent programming in clinical study team and other key meetings (e. g. , protocol reviews, submission readiness) Lead the programming contribution to global regulatory submissions [. .. ] FDA, EMA, ICH, and global regulations and guidelines Solid understanding of industry standards applicable to clinical study data and reporting on clinical trials, including CDISC standards Solid understanding of the drug development process from early to late-stage development and submission Expertise in the requirements and technology to support electronic submissions Strong interpersonal skills in addition to exceptional written and oral communication skills commensurate with the need to work closely with CROs, investigators, consultants, and team members across functions Strong analytical, [. .. ]
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
MEHR INFOS ZUM STELLENANGEBOT
[...] 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 [. .. ] in a complex, cutting-edge environment, we encourage you to apply for this exciting opportunity. Main Responsibilities: Lead and manage the Insu LINK RSO team, ensuring 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 [. .. ]
▶ Zur Stellenanzeige
1 von 4Weiter » Weitere Suchergebnisse laden »
Häufig gestellte Fragen
Wieviel verdient man als Drug Regulatory Affairs pro Jahr?
Als Drug Regulatory Affairs verdient man zwischen EUR 60.000,- bis EUR 90.000,- im Jahr.
Wieviele offene Stellenangebote gibt es für Drug Regulatory Affairs Jobs bei unserer Jobsuche?
Aktuell gibt es auf JobRobot 92 offene Stellenanzeigen für Drug Regulatory Affairs Jobs.
Wieviele Unternehmen suchen nach Bewerbern für Drug Regulatory Affairs Jobs?
Aktuell suchen 13 Unternehmen nach Bewerbern für Drug Regulatory Affairs Jobs.
Welche Unternehmen suchen nach Bewerbern für Drug Regulatory Affairs Stellenangebote?
Aktuell suchen zum Beispiel folgende Unternehmen nach Bewerbern für Drug Regulatory Affairs Stellenangebote:
- Jazz Pharmaceuticals (7 Jobs)
- Abb Vie (2 Jobs)
- Biontech (2 Jobs)
- Hochschule Kaiserslautern University of Applied Sciences (1 Job)
- Octapharma (1 Job)
In welchen Bundesländern werden die meisten Drug Regulatory Affairs Jobs angeboten?
Die meisten Stellenanzeigen für Drug Regulatory Affairs Jobs werden derzeit in Bayern (21 Jobs), Baden-Württemberg (6 Jobs) und Rheinland-Pfalz (6 Jobs) angeboten.
Zu welchem Berufsfeld gehören Drug Regulatory Affairs Jobs?
Drug Regulatory Affairs Jobs gehören zum Berufsfeld Regulatory Affairs & Management.
