What are the responsibilities and job description for the Senior Director Regulatory Affairs position at Meet?
Overview :
Meet is partnered with an innovative biopharmaceutical company dedicated to advancing treatments for rare diseases. We are looking for a driven regulatory professional to join our team as Senior Director, Regulatory Affairs. In this role, you will lead the creation and implementation of regulatory strategies, ensuring compliance with global regulations while supporting product launches, lifecycle management, and other critical initiatives. This is a hybrid position with 2 days in person per week.
Key Responsibilities :
- Lead the development of regulatory strategies and risk mitigation plans.
- Collaborate with cross-functional teams to support product approvals and submissions outside the US.
- Manage global regulatory submissions, ensuring consistency across regions.
- Provide regulatory guidance to product development teams and other functions (CMC, clinical, etc.).
- Draft and finalize responses to regulatory authority queries.
- Stay current on regulatory changes and communicate updates to internal teams.
Qualifications :
