Director, Regulatory Affairs - Ad/Promo and Labeling
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.
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