Director of Regulatory Affairs

Head of Regulatory AffairsMorris County, NJ (On-Site)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 devicesOwn end-to-end lifecycle management (submissions, labeling, updates, renewals)Ensure compliance with FDA regulations, including labeling, claims, formulation, and post-market requirementsPartner cross-functionally with Marketing, Medical, R&D, Supply Chain, and LegalEvaluate licensing and partnership opportunities from a regulatory standpointMonitor and interpret FDA updates, MoCRA, OTC monographs, and communicate impact internallySupport product claims substantiation with Medical and MarketingTranslate clinical data into compliant, consumer-facing messagingOversee pharmacovigilance/cosmetovigilance and post-market surveillance programsManage Prop 65 compliance (CA)Maintain relationships with regulatory authorities and industry stakeholdersWhat you bring:7+ years Regulatory Affairs experience in the U.S. marketStrong background with FDA regulations (OTC drugs, cosmetics, and/or medical devices)Proven experience with regulatory strategy, submissions, and lifecycle managementExpertise in labeling compliance and claims reviewExperience in pharma and/or dermatology environmentsKnowledge of MoCRA and sunscreen monograph preferredStrong leadership + ability to drive cross-functional collaborationBachelor's degree required; advanced degree in Pharmacy, Chemistry, Life Sciences, or related field preferredExperience with clinical evaluation and claims substantiation a plusFamiliarity with regulatory systems/tools (e.g., submission tracking, documentation platforms)Basic Spanish is a plusWhy 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 bonusThe client offers medical, dental, vision and up to 15 days PTO plus sick time and company paid holidays.Equal Opportunity Employer/Veterans/DisabledTo read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.lhh.com/us/en/candidate-privacyThe Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:• The California Fair Chance Act• Los Angeles City Fair Chance Ordinance• Los Angeles County Fair Chance Ordinance for Employers• San Francisco Fair Chance Ordinance