Offer summary
Qualifications:
Bachelor's or advanced degree in scientific discipline, Minimum of 10 years in drug development, At least 8 years in Regulatory Affairs, Experience with INDs/CTAs and NDA/BLA/MAA submissions, Desirable experience in immunology or orphan drug development.
Key responsabilities:
- Develop and implement regulatory strategies
- Lead interactions with regulatory agencies
- Serve as Regulatory Affairs representative on project teams
- Establish timelines for regulatory submissions
- Maintain awareness of current regulatory requirements