Director of Regulatory Affairs

Our client is hiring a Head of Regulatory Affairs to lead all U.S. regulatory strategy and execution across OTC drugs, cosmetics, and medical devices. This is a high-impact leadership role driving compliance, product lifecycle management, and FDA alignment while partnering cross-functionally to support business growth. Here’s the deal: You’ll own the full regulatory lifecycle—strategy, submissions, compliance, and post-market—ensuring products meet FDA standards while staying aligned with commercial goals. What you’ll do: Lead U.S. regulatory strategy and execution for OTC drugs, cosmetics, and medical devices Own end-to-end lifecycle management (submissions, labeling, updates, renewals) Ensure compliance with FDA regulations , including labeling, claims, formulation, and post-market requirements Partner cross-functionally with Marketing, Medical, R&D, Supply Chain, and Legal Evaluate licensing and partnership opportunities from a regulatory standpoint Monitor and interpret FDA updates, MoCRA, OTC monographs , and communicate impact internally Support product claims substantiation with Medical and Marketing Translate clinical data into compliant, consumer-facing messaging Oversee pharmacovigilance/cosmetovigilance and post-market surveillance programs Manage Prop 65 compliance (CA) Maintain relationships with regulatory authorities and industry stakeholders What you bring: 7+ years Regulatory Affairs experience in the U.S. market Strong background with FDA regulations (OTC drugs, cosmetics, and/or medical devices) Proven experience with regulatory strategy, submissions, and lifecycle management Expertise in labeling compliance and claims review Experience in pharma and/or dermatology environments Knowledge of MoCRA and sunscreen monograph preferred Strong leadership + ability to drive cross-functional collaboration Bachelor’s degree required; advanced degree in Pharmacy, Chemistry, Life Sciences, or related field preferred Experience with clinical evaluation and claims substantiation a plus Familiarity with regulatory systems/tools (e.g., submission tracking, documentation platforms) Basic Spanish is a plus Why this role? High visibility. Real ownership. Direct impact on product strategy and compliance in the U.S. market. Salary range: $170,000-200,000 based on experience plus bonus The client offers medical, dental, vision and up to 15 days PTO plus sick time and company paid holidays. Equal Opportunity Employer/Veterans/Disabled #J-18808-Ljbffr LHH