Director, Regulatory Affairs - Labeling & Promotional Review

📍 Los Angeles, CA (Hybrid)

A commercial-stage biotech that just landed its first FDA approval is building out its regulatory leadership team - and this is a rare chance to own labeling and promotional regulatory strategy as the company moves into its next phase of growth.

This is a build-from-the-ground-up opportunity, not a maintain-the-status-quo seat. You'll have direct influence on how the product is positioned in market and how its label evolves as the pipeline matures.

What you'll own:

• Lead the development, negotiation, and lifecycle management of labeling documents (USPI, CCDS, regional labeling) from development through post-approval
• Serve as the regulatory lead on the company's promotional review committee, advising Commercial, Medical Affairs, and Legal on claims, fair balance, and compliant messaging
• Manage submissions to FDA's Office of Prescription Drug Promotion (OPDP) and Advertising/Promotion Labeling Branch (APLB)
• Research competitor labeling and build negotiation strategy for health authority interactions
• Help build the SOPs, processes, and infrastructure this growing function needs as it scales

What we're looking for:

• 7+ years in pharmaceutical or biotech Regulatory Affairs, with direct experience in labeling, advertising/promotion, or both
• Hands-on experience with FDA submissions (labeling documents and/or OPDP/2253 filings)
• Comfortable building process in a fast-moving, lean biotech environment
• Strong cross-functional communicator who can advise confidently across Commercial, Medical, and Legal
• Veeva (PromoMats and/or RIM) experience a plus
• Experience supporting a product launch or label expansion is a strong plus

Compensation: $180,000-$230,000 base, depending on experience and scope, plus bonus and equity.