Manager - Global Regulatory Affairs - ATMP (m|f|d)

Company Description

Miltenyi Biomedicine is a biopharmaceutical company developing personalized chimeric antigen receptor (CAR) T-cell therapies.

We are developing innovative treatments for serious life-threatening diseases and are reshaping their accessibility to patients worldwide with the goal of improving and prolonging patients' lives.

We are currently focusing on difficult-to-treat hematological cancers using CAR-T and other technologies, while also exploring treatments for other diseases.

Our lead candidate, currently in pivotal clinical trials globally, is a tandem CAR T-cell product.

Join our highly professional team in bringing new medicines to market and ensuring the safety of our pharmacological developments at all stages.

Job Description

• You will be responsible for managing and leading regional teams of regulatory affairs professionals in the EU and EMEA for new and approved products on a national or international basis.
• This includes coordinating strategic regulatory activities with full staff and product management authority, as well as regional regulatory strategy and planning in line with the global regulatory strategy.
• Working closely with health authorities to coordinate, communicate and manage all regulatory interactions is another essential part of this position.
• You will also oversee relevant aspects of product safety and quality regarding pharmacovigilance and regulatory requirements.
• Leading the development and maintenance of prescribing information and risk management plans completes the diverse range of responsibilities.

Qualifications

• M.D., Ph.D., or Master's degree in pharmacy, biology, chemistry, or a related field. An advanced degree or certificate in regulatory science is preferred, but not required.
• 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.
• You have a proven track record of successfully leading and developing a team.
• You are a self-starter with excellent organizational and communication skills in English, basic skills in German are preferred, but not required.

Willingness to travel internationally (%)

Additional Information

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

We look forward to your application

If you would like to work in an open, creative and helpful team, we offer you the right environment here. We look forward to receiving your application - with your salary expectations and availability.