Offer summary
Qualifications:
PhD/PharmD with 7+ years in Regulatory Affairs, BS/MS with 10+ years in Regulatory Affairs, Superior scientific writing skills needed, In-depth knowledge of FDA regulations required, Proven success in regulatory agency interactions.
Key responsabilities:
- Develop and coordinate regulatory strategies for product development
- Manage preparations and submissions to regulatory authorities
- Build relationships with key stakeholders and decision makers
- Lead global regulatory submission preparations
- Participate as an active team member on core projects