Regulatory Affairs Director

Location: San Francisco Bay Area (On-site)

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 an Associate Director Regulatory Affairs 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:

1. Lead regulatory strategy development and execution for both U.S. and international markets, focusing on rare liver disease.
2. Interface directly with FDA and other health authorities, contributing to successful NDA filings and lifecycle management of approved products.
3. Oversee regulatory submissions and approvals, ensuring alignment with global regulatory standards.
4. Serve as a strategic advisor in cross-functional labeling and compliance discussions.
5. Collaborate with stakeholders to establish project timelines and regulatory goals.

Minimum Requirements:

1. 10+ years in Regulatory Affairs, including strong FDA interaction and demonstrated experience with NDA submissions.
2. Prior experience bringing a product from development to U.S. filing; EU exposure is a plus.
3. Background in rare or orphan diseases, with liver disease experience highly desirable.
4. Proven ability to work at a director level within a collaborative, dynamic team.
5. Rare disease (MUST)
6. BioPharma (MUST)