Offer summary
Qualifications:
MD, PhD in Life Sciences or advanced degree, Minimum of 5 years in regulatory drug development, Expert knowledge of regulatory affairs, Professional experience with EMA preferred, Extensive experience partnering with EMA required.
Key responsabilities:
- Provide expert regulatory strategy and guidance
- Advise teams on clinical development regulatory strategy
- Collaborate on strategic projects and gap analyses
- Maintain up-to-date knowledge of regulatory requirements
- Engage with national/regional regulatory agencies