Senior Regulatory Affairs Manager (gn) CMC Analytics

  • Medicine, Pharmacy, Laboratory
  • Research, development, teaching
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Formycon is an international leading, independent developer of high-quality biopharmaceutical medicines, especially biosimilars. With an experienced team comprised of more than 200 highly skilled 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.
Our focus is on treatments in ophthalmology and immunology as well as for other key chronic diseases. Formycon is making a major contribution towards providing as many patients as possible with access to vital and affordable medicines.

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 Analytics 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 analytics. This includes but is not limited to the following tasks:
  • Planning, writing and compilation of regulatory documents with focus on CMC documentation for analytical development programs (e.g. characterization studies, analytical similarity/comparability studies, method qualification/validation studies) including lifecycle activities
  • Coordination of regulatory activities with involved stakeholders (e.g. internal functional departments, external CMOs/CROs, license partners)
  • Development and implementation of CMC regulatory strategies during product development and throughout lifecycle. Ensuring that relevant regulatory requirements and guidelines are considered and implemented in the development programs
  • Participation in technical project teams and point of contact for external partners and CMOs/CROs for regulatory topics
  • Review and approval of documents/plans/reports from CMOs/CROs and internal functional departments
  • Leading discussions internally and with external partners and participation in health authority meetings
  • Providing professional guidance and coordinating project support from colleagues

Your qualifications

  • Scientific background with master’s degree or PhD preferably in biotechnology, biochemistry, biology or equivalent
  • Minimum five years of experience in CMC RA area
  • Experience in regulatory CMC requirements for biological products, ideally with focus on analytical aspects
  • Practical experience in compilation of CMC documentation for IMPD/IND, BLA/MAA for biotech products
  • Experience with biosimilars and knowledge of corresponding EMA/FDA guideline requirements would be of advantage
  • Very strong matrix leadership and communication skills
  • Excellent team-player, able to coordinate, prioritize and manage a variety of tasks and issues, proactive and result-oriented, 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
  • Hybrid 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.

For any questions, please feel free to send us an email at