Senior Manager Regulatory Affairs CMC Drug Substance (gn)

  • 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 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

As Senior Manager Regulatory Affairs CMC Drug Substance you will take a leading role in coordination and execution of regulatory CMC activities for dedicated Formycon’s biosimilar and NBE development programs with focus on drug substance:
  • Planning, writing and compilation of regulatory documents with focus on CMC for drug substance development, site transfers and life cycle activities
  • Coordination of regulatory activities with involved stakeholders (e.g. internal functional departments, external CDMOs/CROs, license partners)
  • Development and implementation of CMC regulatory strategies during product development and throughout lifecycle. Ensure that relevant regulatory requirements and guidelines are taken into account and implemented in the development programs
  • Participation in technical project teams and point of contact for external partners and CDMOs/CROs for regulatory topics
  • Review and approval of documents/plans/reports from CDMOs/CROs and internal functional departments
  • Lead discussions internally and with external partners and participate in health authority meetings
  • Provide professional guidance to and coordination of project support from colleagues

Your qualifications

  • Scientific background with master's degree or PhD preferably in biotechnology, biochemistry, biology or equivalent
  • Minimum of five years of experience in CMC RA area
  • Experience in regulatory CMC requirements for biological products is expected, ideally with focus on biotech drug substance manufacturing processes (development and/or tech transfer)
  • Practical experience in compilation of CMC documentation for IMPD/IND, BLA/MAA for biotech products required
  • Very strong matrix leadership and communication skills
  • 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
  • Proficiency in MS-Office
  • German work permit is mandatory

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 4620