Director Regulatory Affairs

Location: San Mateo, CA (Hybrid: 3 days onsite)

Compensation: $186K-$220K base + bonus + equity options

About the Company

A global specialty biopharma company focused on rare genetic and metabolic disorders. With an approved commercial product, multiple programs in clinical development, and year-over-year revenue growth, this organization offers the stability of an established company with the agility of a biotech. Their platform centers on melanocortin-based therapies and innovative delivery systems, targeting conditions with significant unmet need.

About the Role

The Director of Regulatory Affairs will lead U.S. regulatory strategy and contribute to global initiatives across late-stage and post-approval programs. This is a high-impact role with visibility to executive leadership and the opportunity to shape the company's U.S. regulatory hub as it scales.

Key Responsibilities

• Define and execute global regulatory strategies for development and commercialization programs.
• Lead FDA and EMA interactions, including face-to-face meetings and negotiations.
• Oversee and contribute to regulatory submissions (IND, NDA, BLA, Orphan Drug Designations).
• Prepare regulatory teams for Health Authority meetings and ensure compliance with global regulations.
• Support lifecycle management, post-approval changes, and market access activities.
• Mentor and manage a small global regulatory team (direct and indirect reports).

Qualifications

• 15+ years in global regulatory affairs within pharma/biotech.
• Proven experience leading FDA negotiations and securing U.S. drug approvals.
• EMA experience and global regulatory knowledge (ICH guidelines).
• Hands-on experience with IND, NDA, BLA, and ODD submissions.
• Strong leadership, communication, and ability to thrive in a lean, cross-functional environment.
• Tenacity and strategic mindset-comfortable advocating for regulatory positions.

What's on Offer

• Competitive compensation and bonus structure.
• Stock options after one year.
• Relocation assistance available.
• Opportunity to work alongside a seasoned leadership team and gain exposure to commercialization strategy.
• A collaborative culture that combines big pharma resources with biotech flexibility.