Regulatory Affairs

Location : Warren, NJ

Salary : $180,000.00 USD Annually - $200,000.00 USD Annually

Description : Our client is currently seeking a Director, Regulatory Affairs

About the Role

We're looking for a strategic and experienced regulatory leader to drive the review and compliance of advertising, promotional, and labeling materials across our biotech portfolio. You'll lead the Medical, Legal, and Regulatory (MLR) Review Committee, partner cross-functionally, and ensure our product communications meet FDA standards while remaining impactful and innovative.

What You'll Do

• Lead regulatory review of promotional and labeling materials for Rx and OTC (dietary supplement) products.
• Chair and manage MLR / PRC meetings, ensuring timely and compliant approvals.
• Interpret FDA regulations (including OPDP guidance) and apply best practices to promotional content.
• Collaborate with Commercial, Legal, and Medical Affairs to align messaging with strategic goals.
• Provide regulatory guidance on labeling : packaging, prescribing information, IFUs, Supplement Facts, and Core Data Sheets.
• Manage FDA interactions related to promotional submissions and advisory comments.
• Monitor regulatory trends and translate insights into actionable strategies.
• Deliver internal training on promotional compliance and regulatory expectations.
• Support new product launches and lifecycle promotional strategy.
• Mentor junior regulatory team members.

What We're Looking For

Bonus Points

By providing your phone number, you consent to : (1) receive automated text messages and calls from the Judge Group, Inc. and its affiliates (collectively "Judge") to such phone number regarding job opportunities, your job application, and for other related purposes. Message & data rates apply and message frequency may vary. Consistent with Judge's Privacy Policy, information obtained from your consent will not be shared with third parties for marketing / promotional purposes. Reply STOP to opt out of receiving telephone calls and text messages from Judge and HELP for help.

Contact : anarayan@judge.com

This job and many more are available through The Judge Group. Find us on the web at www.judge.comPandoLogic. Category : , Keywords : Compliance Director