Regulatory Affairs Manager (CMC) - Drug Product Development (gn)

  • Work experience
  • Medicine, Pharmacy, Laboratory
  • Research, development, teaching
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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

  • Planning, writing and compilation of regulatory documents for Formycon`s biosimilar development programs with focus on CMC documentation for drug product development, site transfers and lifecycle activities
  • Coordination of regulatory activities for Formycon`s Biosimilar development programs 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. Ensure that relevant regulatory requirements and guidelines are taken into account and implemented in the biosimilar 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
  • Regulatory compliance check of documents and evaluation of change controls
  • Support design control for combination products and related regulatory documents

Your qualifications

  • Scientific background with bachelor or master degree preferably in biology, biotechnology, pharmaceutical sciences, chemistry or equivalent
  • Practical experience in compilation of CMC documentation for IMPD/IND, BLA/MAA required
  • Ideally two or more years of experience in CMC RA area with focus on aseptically manufactured drug products
  • First experience with design control process for combination products or medical devices would be of advantage
  • Experience with biosimilars and knowledge of corresponding EMA/FDA guideline requirements would also be of advantage
  • Ability to coordinate, prioritize and manage a variety of tasks and issues
  • Team player, flexible and dedicated personality
  • Fluent in English (German language a plus)

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