Senior Manager Regulatory Affairs - CMC Project Coordination (gn)

  • Planegg
  • Work experience
  • Senior, very experienced
  • 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 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 Regulaory Affairs 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

As Senior Manager  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 biosimilar products.Your reporting line is to the VP Regulatory Affairs and Quality Management.

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 with various parties involved, e.g. internal RA CMC groups (DS, DP, Analytics), production, supply chain and license partners. This includes the following tasks:
  • Lead and coordinate assigned regulatory CMC projects during product development phase as well as product lifecycle and align with involved internal and external stakeholder, e.g.
    • 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 (e.g. for Japan submission) 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 partners
  • Support VP RA in project, capacity and budget planning activities for RA CMC department
  • 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 for biologics and proven track record in late stage development and participation of product submissions/lifecycle management
  • Extensive practical experience in Regulatory CMC for biotechnology derived products is a must, biosimilar knowledge would be of advantage
  • Experience in product lifecycle management and requirements for products with global market scope would be beneficial
  • 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
  • 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.

Our recruiting process is supported by the recruiter service by Constares GmbH. For initial questions, please contact Rebecca Schön: +49 89 1241 46 204