Associate Manager Regulatory Affairs

  • Medicine, Pharmacy, Laboratory
  • Fulltime
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Formycon is a leading, independent developer of high-quality biopharmaceutical medicines, especially biosimilars.
With an experienced team comprised of more than 170 professionals, the company is able to span the entire value chain of biosimilar drug development, from market analysis and protein analytics, to the development of production processes, to clinical trials and the regulatory approval process.

Formycon is making a major contribution towards providing as many patients as possible with access to vital and affordable medicines. Based on its extensive experience in the development of biopharmaceutical drugs, the company is also working on the development of a COVID-19 fusion protein.

To support our team in Martinsried near Munich, we are looking for suitable candidates for this full-time and permanent position, to begin work as soon as possible.

Your responsibilities

  • Support compilation of documents for scientific advice requests, IMPDs, dossiers other regulatory documents
  • Support RA Team by providing document templates and support in document formatting and rendition
  • Coordinate review and approval of regulatory documents
  • Handover of regulatory documents to external partner, e.g. publishing company or license partner
  • Maintain tracking lists for dossiers and country submission status
  • Processing of source documents and data for adapting it for regulatory documents
  • Filing and archiving of regulatory documents

Your qualifications

  • Completed vocational training as a biological-technical assistant (BTA), chemical-technical assistant (CTA), medical documentation assistant (MDA), pharmaceutical-technical assistant (PTA),  or scientific background with bachelor or master degree preferably in biology, biotechnology, pharmaceutical sciences, chemistry or equivalent
  • Ideally one or more years practical experience in RA area
  • Attention to detail required
  • High proficiency in MS-Office, especially MS Word
  • Very good team player, result oriented, well organized, proactive, problem solver and able to work independently
  • Creativity and enthusiasm for working in a dynamic fast growing biopharmaceutical company
  • Fluency in written and spoken English required, German knowledge is desirable
  • German work permit is mandatory

We offer

  • Flexible working time
  • mobile working
  • 30 days paid vacation
  • Formycon pension
  • Group accident insurance
  • Formycon card
  • Continuing education offers
  • Team spirit and great working atmosphere (table football, table tennis, free drinks etc.)
  • and much more!

Bring us your skills and energy, and shape your own career in a stimulating and open work environment. We are looking for highly motivated individuals who are ready to take on new challenges with enthusiasm and personal commitment. Working at Formycon means being part of a smart, innovative team with minimal hierarchy and opportunity to share your own ideas.

Have we sparked your interest? Then we look forward to receiving your application for employment through our online application portal. Please be sure to include all supporting documents, along with your earliest possible starting date and your salary expectations. We look forward to learning about you and the qualifications which you would bring to this position.

Our recruiting process is supported by the recruiter service by Constares GmbH. For initial questions, please contact Rebecca Schön: +49 89 1241 46 204