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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
Wer wir sind With more than 12,000 employees Roche Diagnostics GmbH (RDG) represents the third largest site within Roche. Apart from the two sales organizations in Germany (Roche Pharma AG and Roche Diagnostics Deutschland) RDG is focused on the operative business. At the two sites in Mannheim and Penzberg new diagnostic tests and pharmaceutical active ingredients are developed and produced for the global market.