Regulatory Affairs Manager (gn)

  • Medicine, Pharmacy, Laboratory
  • Quality Management, Quality Assurance
  • 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 target definition by 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

  • Manage activities relating to development of regulatory documents and other operational documents as appropriate as well as any updates/amendments to those documents
  • Actively collaborate and liaise with other development functions on biosimilar issues, e.g. Regulatory CMC, Non-Clinical and Clinical Development, external consultants, and participate in cross-functional teams
  • Prepare, coordinate and compile parts of regulatory dossiers for worldwide submissions including Clinical Trial Applications, Briefing Books, responses to questions from regulatory authorities according to project progress and requirements
  • Ensure flow of information is tracked and actively monitors progress identifying issues for resolution
  • Assure correct document formatting according regulatory requirements as well as filing and archiving of documentation

Your qualifications

  • MSc/PhD in biotechnology, biology or biochemistry (or equivalent)
  • 3-5 years industrial experience in regulatory topics for regulatory affairs with background on biotech products, experience in CTAs or clinical matters of biotech products
  • Ideally track record in international regulatory affairs and biotech products with practical experiences of registration procedures like CTA/IND submissions
  • Development experience with biological drugs, ideally with Biosimilars
  • Excellent planning, communication, documentation and organizational skills with hands-on mentality
  • Ability to work successfully in a matrix organization
  • Knowledge of relevant legislation and international guidelines for regulatory affairs
  • Very good English (written and oral) language skills
  • Experience in basic software (Word, Excel, Power Point)

We offer

  • Flexible working time
  • mobile work
  • 30 days paid vacation
  • Formycon pension
  • Group accident insurance
  • Formycon card
  • Continuing education offers
  • Team spirit, great working atmosphere 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