Job Title: Associate Director Regulatory Affairs (Temp to Perm)
Location: San Francisco Bay Area
Commitment: 12-month contract,
Overview:
Join a well-established biopharma company with a strong track record of success in rare and orphan diseases, particularly in hepatology. This position provides an exciting opportunity for a Regulatory Director to support a recently approved product and lead the regulatory strategy on a new project. This role is ideal for professionals seeking growth and impact in a supportive, dynamic environment.
Key Responsibilities:
- Lead regulatory strategy development and execution for both U.S. and international markets, focusing on rare liver disease.
- Interface directly with FDA and other health authorities, contributing to successful NDA filings and lifecycle management of approved products.
- Oversee regulatory submissions and approvals, ensuring alignment with global regulatory standards.
- Serve as a strategic advisor in cross-functional labeling and compliance discussions.
- Collaborate with stakeholders to establish project timelines and regulatory goals.
Minimum Requirements:
- 10+ years in Regulatory Affairs, including strong FDA interaction and demonstrated experience with NDA submissions.
- Prior experience bringing a product from development to U.S. filing; EU exposure is a plus.
- Background in rare or orphan diseases, with liver disease experience highly desirable.
- Proven ability to work at a director level within a collaborative, dynamic team.