Miltenyi Biotec continues to grow. Our corporate culture encourages you to shape your own ideas and to create a new dynamic. Welcome to a team that thrives on innovation.

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

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.

Your role

  • In your role as a Junior Regulatory Affairs Manager you support the RA department for the EU-submissions for our products in cell and gene therapy with focus on clinical trials
  • Using your passion for organization, you help us building up necessary path structures and processes to optimize our workflow and organize meetings.
  • You support the team in providing regulatory assessment of changes, such as manufacturing process changes (change control). This includes the determination of the impact of the change on regulatory filings and the assistance in preparation of appropriate documents.
  • In addition, you support the preparation and review of regulatory documents. Together with your team, you take care of the submission of those documents to the responsible national and international competent authorities using eCTD (electronic common technical documents).

Your profile

  • You have successfully completed your PhD in biology, chemistry or a similar field.

  • You are interested in regulatory affairs und product development with a focus on biologics.

  • Experiences with eCTD should be available, further experiences with IND, BLA/NDA are welcome.
  • You have a passion for organization and regulations, and have a good knowledge of the relevant laws and guidelines.
  • You love to 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 your salary expectations.

Your contact

Annette Weis
+49 151 40258212

Apply Now

Miltenyi Biotec B.V. & Co. KG
Human Resources
Friedrich-Ebert-Strasse 68
51429 Bergisch Gladbach Germany
www.miltenyibiotec.com/jobs