(Senior) Manager (gn) Regulatory Affairs- CMC Project Coordination

  • Work experience
  • Medicine, Pharmacy, Laboratory
  • Quality Management, Quality Assurance
  • Fulltime
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Formycon is an international leading, independent developer of high-quality biopharmaceutical medicines, especially biosimilars. With an experienced team comprised of around 240 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.

As (Senior) Manager (gn) Regulatory Affairs - CMC Project Coordination you will be responsible for planning, oversight, and coordination of RA CMC projects during development as well as product lifecycle for Formycon’s biosimilar products.

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

In your new role you will have a key role in overseeing RA CMC projects within the regulatory department. You will coordinate and align assigned projects during product development phase as well as product lifecycle with various parties involved, e.g., internal RA CMC groups (DS, DP, Analytics), production, supply chain and license partners. This includes the following tasks:
  • Coordinate compilation of CMC part of briefing books for health authority interactions and support meeting preparation
  • Oversee compilation of quality part of IMPDs for CTA applications
  • Plan, coordinate and ensure preparation of Module 3 parts within agreed timelines for  defined regions together with assigned RA CMC Managers
  • Coordinate and drive region specific adaptations of CMC dossiers and associated activities  together with internal departments, license partners or consultants
  • Establish strategies and plans for major lifecycle projects, like tech transfers or launches of additional dosage forms
  • Develop global submission plan strategies in the context of global rollout of a product    together with business development, supply chain and involved license partners
  • Oversee global registration status and maintain respective data bases 
In addition to overseeing your assigned RA CMC projects you will contribute to continuous improvement projects for CMC dossier compilation, tracking tools and establishment of lifecycle management activities.

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 and proven track record in late-stage development and in lifecycle management
  • Understanding of in submission requirements for products with global market scope
  • Biosimilar knowledge is advantageous
  • Very strong matrix leadership and communication skills
  • Fluent in written and spoken English
  • Very good team player, result oriented, persistent, well organized, proactive, problem solver and able to work independently

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 send us an email at recruiting@formycon.com.