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Regulatory Affairs Manager Pharma/Biotech – (m|f|d)

Your role

At Miltenyi Biotec, 3000 employees worldwide develop pioneering solutions for biomedical science and the clinical application of cell therapies. Our multidisciplinary team combines excellence in research with the development of innovative products for the treatment of serious diseases. In the newly created Miltenyi Biomedicine GmbH, a daughter company of Miltenyi Biotec focusing on pharma, we bundle our activities for the development and marketing of cell therapeutics.

  • In your role as a Regulatory Affairs Manager you support and maintain the EU-submissions with focus on Clinical Trial Authorization Application.
  • This means you prepare, review and submit regulatory documents to national competent authorities (e.g. IMPD, ERA, eCTD etc.).
  • In collaboration with internal and external experts you will generate and submit the responses to question for health authorities.
  • In cross-functional project teams you will represent the Regulatory Affairs Department and work closely with your colleagues to ensure timely approval of new drug products and maintain marketing authorizations.

Your profile

  • You hold a Master Degree in biology, chemistry or a similar field. A Ph.D. is a plus but not mandatory.
  • You have at least 5 years of experience in regulatory affairs, product development and submission management with a focus on biologics. ATMP experience would be a plus.
  • A profound knowledge in the compilation of documents and submission management for EU CTAs in multiple EU Member States/other European States (knowledge of country-specific requirements) round off your profile.
  • Experiences with eCTD should be available, further experiences with IND, BLA/NDA are welcome.
  • Sound business judgment and collaboration skills, with a demonstrated ability to interact and influence at all levels round off your profile.
  • You have excellent organizational skills, work independently and have strong communication skills (oral and written) in English.

What we offer

  • A modern workplace and 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 training academy
  • Diverse corporate benefits with regard to employee health, sport, and staff events

Contact us

If you have the skills and qualifications for this position, please use the link to send us your details (application letter, curriculum vitae, references and certificates). Please give us some idea of when you can start and the kind of salary you are looking for.

Ihr Ansprechpartner

Nadia Boutari
Tel.: +49 2204 8306-2440

Miltenyi Biotec B.V. & Co. KG
Human Resources
Friedrich-Ebert-Strasse 68
51429 Bergisch Gladbach Germany