Head of Regulatory Affairs

Job Description

Job Description

Head of Regulatory Affairs
Morris 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 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.

Pay Details: $170,000.00 to $200,000.00 per year

Search managed by: Heather Stott-Mason

Equal Opportunity Employer/Veterans/Disabled

Military connected talent encouraged to apply

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The 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

Massachusetts Candidates Only: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.