Manager Technical Regulatory Affairs (m/f/d)

Germany, Bavaria, Penzberg

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Job description:

The Technical Regulatory Affairs department in Penzberg is responsible for all technical regulatory questions regarding biotechnological drugs in all stages from development to marketing of the product. We ensure that technical regulatory documents are provided in high quality and in accordance with global timelines. We set up regulatory strategies aiming for the development and production of innovative medicines that meet the highest standards for quality, safety and efficacy.

As a Manager Technical Regulatory Affairs (m/f) in the division Pharma Biotech Penzberg your duties would consist of the following areas of responsibility:

  • You generate and coordinate the lifecycle of regulatory documentation regarding development, manufacturing and quality control of biotechnological medicinal products in consideration of the relevant regulatory guidelines
  • Beyond that you ensure the development and progress of projects in alignment with the global project team
  • In collaboration with the project team you are accountable for the response to enquiries and deficiency reports from regulatory authorities
  • The preparation and conduct of health authority meetings is also part of your work
  • You are involved in the tracking and assessment of new regulatory guidelines, and their implementation, if required
  • In addition, you are the contact for all regulatory affairs departments at the different company sites, as well as for external partners and clients, for each of your projects

Who you are:

  • You hold a university degree and ideally also a Ph.D. in a life science discipline like Biology, Chemistry or Pharmacy
  • You have several years of experience in the pharmaceutical industry in the areas of Regulatory Affairs, Technical Documentation or Regulatory Quality Requirements concerning Biologics
  • We can trust in your detailed knowledge of regulatory guidelines (FDA, EMEA, ICH, GMP, etc.)
  • You enjoy working in a team
  • We can rely on your excellent communication and moderation skills at all times
  • You have established a highly reliable and accurate working style
  • Excellent proficiency in spoken and written German and English conclude your profile

In general this position also suitable for a part-time employment.

This position is limited to a timeframe of two years.

We look forward to your complete application in English, including cover letter and CV.

Whom to contact:                  L. Kühne

Telephone number:               +49 8856 60 6531