Senior Manager Regulatory Affairs - Life Cycle Coordination (gn)

  • Medicine, Pharmacy, Laboratory
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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 - Life Cycle Coordination you will be responsible for oversight and coordination of RA product lifecylce for Formycon biosimilar products in approved markets.
In your new role you will be acting as a regulatory expert coordinating and aligning RA dossier lifecycle with various parties involved, e.g. internal RA CMC, production, supply chain and license partners. Your reporting line is to the VP Regulatory Affairs and Quality Management.
 
  • Develop, lead and implement global regulatory CMC maintenance strategy and align with involved internal and external stakeholder
    • Assess proposed CMC changes for global impact to ongoing filings and existing MAs and contribute to regulatory change control
    • Manage/coordinate CMC document updates/packages with internal RA CMC functions for regulatory submissions in support of lifecycle activities to ensure regulatory compliance and continuity of supply chain
    • Ensure timely provision of CMC variation packages for country submissions to partners
    • Maintain Master/ROW dossiers for further submissions and coordinate country specific adaptations with license partners as needed
  • Keep oversight of global submission status of submitted dossiers, variations and regulatory commitments (ongoing filings and approved MAs)
    • Ensure that respective data bases are up to date
    • Keep oversight of variations and regulatory commitments and ensure timely follow-up
  • Contribute to continuous improvement of lifecycle activities and associated processes
    • Support establishment of respective processes at Formycon together with involved internal and external stakeholders
    • Establish lessons learned from lifecycle activities for other projects still in development phase

Your qualifications

  • Scientific background with master degree or PhD, preferably in biology, chemistry, biochemistry or equivalent
  • Minimum of 5 years of work experience in Regulatory CMC & product maintenance functions
  • Thorough knowledge of product lifecycle requirements for products with global market scope
  • Experience in regulatory CMC requirements for biological products is expected
  • Very strong matrix 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, 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