- Remote, United States
- Remote
- Full-time · Director
- $176K–$236K per year
- 10+ years
The Director, Regulatory Affairs will be responsible for developing, implementing, and advising on North America (NA) regulatory strategies for development programs to secure and maintain market access in NA for product(s) in line with business objectives.
Compensation
Salary Range: $176,000.00 - $236,000.00 annually
Responsibilities
- Provide high level regulatory strategic and operational direction for NA and mentorship on projects
- Oversee the preparation and submission of documentation to support investigational and marketing registration packages within the US and Canada
- Liaise and negotiates with the FDA and Health Canada as needed for all aspects pertaining to drug development
- Trains, develops, and manages an effective regional regulatory team
Requirements
- Bachelor’s degree
- advanced degree preferred
- Nice to have: Experience working as a lead in Regulatory Affairs with the FDA
- Nice to have: Experience with small molecules and biologics