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Regulatory Affairs Manager
vor 1 Monat
Company Overview
Miltenyi Biomedicine is a biopharmaceutical company dedicated to developing personalized chimeric antigen receptor (CAR) T-cell therapies for serious life-threatening diseases. Our mission is to improve and prolong patients' lives by bringing innovative treatments to market.
Job Summary
We are seeking a highly skilled Regulatory Affairs Manager to lead our regional teams in the EU and EMEA for new and approved products. The successful candidate will coordinate strategic regulatory activities, work closely with health authorities, and oversee product safety and quality.
Key Responsibilities
- Manage and lead regional teams of regulatory affairs professionals in the EU and EMEA.
- Coordinate strategic regulatory activities with full staff and product management authority.
- Develop and maintain regional regulatory strategy and planning in line with the global regulatory strategy.
- Work closely with health authorities to coordinate, communicate, and manage all regulatory interactions.
- Oversee relevant aspects of product safety and quality regarding pharmacovigilance and regulatory requirements.
- Lead the development and maintenance of prescribing information and risk management plans.
Requirements
- M.D., Ph.D., or Master's degree in pharmacy, biology, chemistry, or a related field.
- 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, to challenge traditional views while respecting best practices, and to present and argue cases in a professional and respectful manner.
- Proven track record of successfully leading and developing a team.
- Excellent organizational and communication skills in English, basic skills in German are preferred, but not required.
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.
