Technical Drug Regulatory Affairs Manager (m/f) 80-100%
Pharma Technical Regulatory (PTR) acts as the center of excellence for all technical regualtory activities for global development and marketed product. The Technical Durg Regulatory Affair Manager in the Biotech Development Group sets and maintains the technical regulatory standards for the Chemistry Manufacturing and Control (CMC) submissions. You will be responsible for developing and executing regulatroy strategies for products under development.
- Represent the technical regulatory function on cross-funcitional teams with respect to Drug- and Device Combination Product
- Provide strategic leadership and regulatory guidance to the teams/functions on technical regulatory Drug- and Device Combination Product issues
- Successfully negotiate technical regulatory plans
- Manage the generation of high quality global regulatory submissions for clinical trials and marketing authorization applications in collaboration with the other disciplines apart from your proven Regulatory CMC experience with regards to preparation of regulatory applications and submissions, planning of regulatory strategies, assessing regulatory complinace and supporting quality systems, we require knowledge in Biotechnology as well as Drug - and Device combination Product experience.
- University degree (Master or PhD) in a scientific discipline
- Minimum 3 years of industry experience in regulatory, and Drug- and Device comibnation Product
- Fluet in English, German oral
- Excellent communication, collaboration, and interpersonal skills
- Effective problem solving and strong organizational skills, including ability to prioritize tasks