For my customer, an innovative biotech company with an office in Baden-Württemberg, I am looking for a Senior Regulatory Affairs Manager. The company currently has more than 50 scientists working on the development of new products and you could be part of this team.
- Devise regulatory strategy for new and existing development programs
- Prepare and submit regulatory documents to global regulatory bodies ensuring high-quality technical writing standards
- Coordinate the dossier submission process and ensure documents are delivered within the program timelines
- Communicate directly with regulatory authorities
- Devise SOPs to ensure compliance
- Coordinate project teams and manage budgets
Your Qualifications & Experience:
- Master's Degree or equivalent in natural sciences
- At least 5 years' experience in drug development
- Good understanding of regulatory processes
- International experience (EU, USA etc.)
- Fluent English is a must
The Next Step:
If you want to work for an innovative biotech company and take on a wide range of tasks, then this is the right position for you! Please apply by email.
Andrew Pride - Principal Consultant Regulatory Affairs
T: +49 (0) 89 - 551 977 67
Progressive München - Pharma
Sthree Germany is acting as an Employment Agency in relation to this vacancy.