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Regulatory Affairs Manager (m|f|d)

Regulatory Affairs – Bergisch Gladbach

Miltenyi Biomedicine is a newly established international biopharmaceutical company that develops innovative cell and gene therapies. We are focused on bringing cancer treatments and regenerative therapies to patients. Our initial focus is on difficult to treat hematological cancers using CAR-T technology whilst exploring treatments for solid tumors.  We are currently in discussion with the FDA, EMA and Japanese health authorities regarding initiating pivotal Phase II trials. We strongly believe that despite promising developments, there is significant room to improve on current cancer therapies.

Your role

 

  • In your role as a Regulatory Affairs Manager, you support and maintain the RoW countries such as CH, CA, South Korea, TW, AUS (and others) as well as EU and US submissions.
  • In doing so, your tasks are to organize, prepare and review regulatory documents for these countries.
  • In collaboration with internal and external experts, you will generate the responses to questions 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 pharmacy, 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/or 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 the RoW countries as listed above or similar regions are mandatory. Experiences with eCTD should be available.
  • Sound business judgment and collaboration skills, with a demonstrated ability to interact and influence at all business levels round off your profile.
  • You work independently and have excellent organization and communication skills, both in English and German (verbal and written).
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

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.

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