My Munich based client is looking for an experienced Regulatory Affairs Professional to assist with their developing oncology pipeline. They are looking to take their Phase III compound to market by 2024 and have another 4 innovative molecules in early clinical development for targeted cancer therapies, for treatment of gliobastoma, prostate cancer and other conditions.
Key Responsibilities include:
- Leadership of the Global Regulatory Affairs team.
- Responsibility for development of regulatory strategies for new products in clinical development.
- Co-development and management of regulatory department budgets
- Consultancy in due diligence and early development projects
The correct candidate will demonstrate:
- Global Regulatory Affairs experience in a leading position in the pharmaceutical/biotech industry, in both clinical and CMC regulatory affairs
- Experience in NDA and Drug approval
- Intensive experience in working with FDA and EMA authorities
- Minimum 10 years of regulatory and drug/biologic development experience with main focus on oncology indication
Should you be interested, please apply here or send your CV and availability to speak