Head of Regulatory Affairs CMC Analytics (gn)

  • Medicine, Pharmacy, Laboratory
  • Research, development, teaching
  • 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 Regulatory Affairs department 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 Head of Regulatory Affairs CMC Analytics you will be responsible for aligning and implementing regulatory strategies for all analytical work packages for Formycon`s product pipeline.

In this role you will lead a team of ≥ 5 RA managers with focus on analytical tasks and work packages. You will be acting as a regulatory expert coaching your team and aligning analytical strategies with experts from various departments and external partners. Your reporting line is to the VP Regulatory Affairs and Quality Management. Your main tasks include the following:
  • Align RA CMC analytical strategy for Formycon’s development projects and lifecycle products (focus biosimilars) with project management, project analytics, analytical departments and other RA CMC groups (DS and DP)
  • Review and align strategy for essential overarching concepts with focus on analytics (e.g. analytical development masterplan, similarity assessment, DS/DP comparability) and define presentation in regulatory dossiers
  • Ensure timely preparation and appropriate review of regulatory documents for Briefing Books, IMPD/IND, BLA/MAA submissions
  • Guide RA CMC Analytics team in defining the best strategy for each submission and their content
  • Support defining response strategy for analytical requests from authorities in close collaboration with involved analytical SME departments
  • Maintain knowledge of global competitive landscape, regulatory environment, and regulations with focus on analytical aspects and requirements for biosimilar development
  • Participate in meetings with regulatory agencies (e.g. EMA, FDA)
  • Manage capacity allocation in team and coordinate regulatory CROs in charge of assigned work packages
  • Compile and maintain budget and capacity plans

Your qualifications

  • Scientific background with master degree or PhD, preferably in biology, chemistry, biochemistry or equivalent
  • Minimum of 6 years work experience in Regulatory CMC area and analytical functions (QC, analytical development; project analytics)
  • Thorough knowledge of the drug development process with demonstrated experience in multiple development phases up to submission
  • Experience in regulatory CMC requirements for biosimilar development is expected
  • Excellent staff leadership and communication skills
  • Fluent in written and spoken English; German knowledge would be of benefit
  • Very good team player, result oriented, persistent, well organized, proactive, problem solver and able to work independently
  • 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
  • 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.