Senior Manager Regulatory Affairs -Japan (gn)

  • Medicine, Pharmacy, Laboratory
  • Quality Management, Quality Assurance
  • 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 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 this role you will be responsible for oversight and coordination of regulatory strategy and submission planning for Formycon’s biosimilar products in Japan scope.
You will be acting as a regulatory expert coordinating and aligning regulatory requirements and strategies with various parties involved, e.g. internal development functions as well as production, supply chain and license partners. Your reporting line is to the VP Regulatory Affairs and Quality Management
This position includes the following tasks and responsibilities:
  • Contribute to global regulatory strategy and implement regulatory requirements needed for Japan
  • Drive necessary authority interactions with PMDA for alignment of global development program
  • Manage compilation of CTD for submission in Japan taking local requirements into account and coordinate with local consultants/license partners as needed
  • Provide guidance and support to other departments on regulatory requirements for Japan
  • Continuously monitor regulatory landscape and updates in Japan

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 functions
  • Thorough knowledge of regulatory requirements for biopharmaceutical products intended for Japanese market
  • Proven track record in submitting biological products to PMDA is expected
  • Experience with biosimilars would be of benefit
  • Very strong matrix leadership and communication skills
  • Fluent in written and spoken English; Japanese 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 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