Associate Director/Director, Regulatory Affairs Advertising & Promotions

Tris Pharma Inc•South Brunswick, NJ

3d•$160,000 - $230,000•Hybrid

About The Position

Tris Pharma, Inc. is a leading privately-owned US biopharmaceutical company focused on the development and commercialization of innovative medicines in ADHD, spectrum disorders, anxiety, pain, and addiction. The company has over 150 US and International patents and markets several branded ADHD products. They are seeking an experienced Associate Director or Director, Advertising & Promotions to join their Regulatory Affairs team at their Monmouth Junction, NJ office. This position offers senior regulatory oversight for the review and approval of promotional materials and external communications, ensuring accuracy, balance, substantiation, and compliance with FDA regulations, guidance, industry standards, and company policies. The role involves providing strategic regulatory advice, leading complex promotional reviews, managing FDA submissions, and improving review processes. The incumbent will also serve as a secondary contact to the FDA Office of Prescription Drug Promotion (OPDP) and ensure timely and compliant submissions.

Requirements

Associate Director - PhD or PharmD in life sciences, pharmacy, medicine or a related discipline and minimum 3 years’ experience as a regulatory reviewer of advertising and promotional materials in the pharmaceutical, biotechnology or related industry REQUIRED
Associate Director - Bachelors degree in life sciences, pharmacy, medicine or a related discipline and minimum 7 years’ experience as a regulatory reviewer of advertising and promotional materials in the pharmaceutical, biotechnology or related industry REQUIRED
Director - PhD or PharmD in life sciences, pharmacy, medicine or a related discipline and minimum 4 years’ experience as a regulatory reviewer of advertising and promotional materials in the pharmaceutical, biotechnology or related industry REQUIRED
Director - Bachelors degree in life sciences, pharmacy, medicine or a related discipline and minimum 8 years’ experience as a regulatory reviewer of advertising and promotional materials in the pharmaceutical, biotechnology or related industry REQUIRED
In-depth knowledge of FDA regulations and their interpretation relevant to prescription drug advertising, promotion and labeling REQUIRED
Direct experience interacting with FDA OPDP REQUIRED
Ability to influence without direct authority REQUIRED

Responsibilities

Reviews and approves advertising and promotional materials ensuring compliance with applicable FDA laws, regulations and guidance documents
Provides strategic input and clear regulatory advice towards the development of compliant yet competitive advertising and promotional material
Key resource for regulatory advice on promotional and advertising initiatives throughout the company
Maintains continued awareness and understanding of new and existing FDA regulations, guidance documents and enforcement actions regarding advertising and promotion of pharmaceutical products and communicates these to PRC and senior management, as needed
Provides training regarding FDA expectations on advertising and promotion, as requested
Provides strategic input on regulatory requirements for claim substantiation for desired promotional claims to enhance marketability of product portfolio
Prepares and approves Form FDA-2253 submissions to OPDP
Contributes to, and drives, Advertising and Promotion regulatory process improvements in relevant areas, as needed