Regulatory Affairs Specialist
vor 2 Wochen
About Miltenyi Biomedicine
Miltenyi Biomedicine is a biopharmaceutical company dedicated to advancing personalized cell and gene therapies. Our mission is to improve and extend patients' lives by pioneering groundbreaking therapies for serious life-threatening diseases.
Job Summary
We are seeking a highly skilled Regulatory Affairs representative to manage investigational and approved advanced medicinal therapy products on a national or international basis. The successful candidate will be responsible for operational management, regional regulatory strategy, and planning in line with the global regulatory strategy.
Key Responsibilities
- Manage investigational and approved products on a national or international basis, including operational responsibility and regional regulatory strategy.
- Coordinate and communicate with health authorities to manage regulatory interactions.
- Contribute to product safety and quality aspects regarding pharmacovigilance and regulatory requirements.
- Develop and maintain prescribing information and risk management plans.
Requirements
- M.D., Ph.D., or other degree in pharmacy, biology, chemistry, or a related field. An advanced degree or certificate in regulatory science is preferred.
- Several years of relevant experience in EU regulatory affairs, drug development, and/or submission management with a focus on ATMPs and biologics.
- Sound business judgment and collaborative skills, as well as proven ability to interact and influence at all levels of a dynamic organization.
- Ability to build and maintain strong cross-functional relationships and present cases in a professional and respectful manner.
- Excellent organizational and communication skills in English, basic skills in German are preferred.
What We Offer
- A modern workplace in Bergisch Gladbach with opportunity for some mobile work.
- Exciting opportunities in the development of technologies with a secure future.
- Cross-border intercultural cooperation and short communication channels.
- A collegial corporate culture and flexible working hours enable time management on your own terms.
- Personalized employee development program: specialist and personal training courses provided by our own Miltenyi University.
- Diverse corporate benefits with regard to employee health, sport, and staff events.
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