Associate Director/Director, Regulatory Affairs Advertising & Promotions

Tris Pharma•Monmouth Junction, NJ

3d•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, addressing unmet patient needs. The company has over 150 US and International patents and markets several branded ADHD products in the US. They also license their products in the US and ex-US markets. Their robust pipeline of innovative products employing proprietary science and technology spans neuroscience and other therapeutic categories. This position provides senior regulatory oversight for the review and approval of promotional materials and related external communications for products. Reporting to the Head, Regulatory Affairs Advertising and Promotion, the incumbent helps ensure materials are accurate, balanced, substantiated, consistent with Food and Drug Administration (FDA) approved labeling, and compliant with applicable FDA regulations, guidance, industry standards, and company policies. The role supports compliant business execution by providing strategic regulatory advice, leading complex promotional reviews, managing FDA submission requirements, and improving review processes. The incumbent serves as a secondary company contact to the FDA Office of Prescription Drug Promotion (OPDP) and helps ensure materials are submitted to the FDA in an accurate, compliant, and timely manner to meet company goals.

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.
Serves as a 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.