Associate Director/Director, Regulatory Affairs Advertising & Promotions

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. With over 150 US and international patents, Tris markets several branded ADHD products in the US and licenses products domestically and internationally. The company’s robust pipeline spans neuroscience and other therapeutic categories, leveraging proprietary science and technology.

About the role

This position provides senior regulatory oversight for the review and approval of promotional materials and related external communications for products. Reporting to the Head of Regulatory Affairs Advertising and Promotion, the incumbent ensures materials are accurate, balanced, substantiated, consistent with FDA-approved labeling, and compliant with applicable 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 the secondary company contact to the FDA Office of Prescription Drug Promotion (OPDP) and ensures timely and compliant submissions to the FDA.

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 for the development of compliant yet competitive advertising and promotional materials.
• Serves as a key resource for regulatory advice on promotional and advertising initiatives across the company.
• Maintains awareness of new and existing FDA regulations, guidance documents, and enforcement actions related to advertising and promotion, and communicates these to the Promotional Review Committee (PRC) and senior management as needed.
• Provides training on FDA expectations for advertising and promotion upon request.
• Offers strategic input on regulatory requirements for claim substantiation to enhance the marketability of the product portfolio.
• Prepares and approves Form FDA-2253 submissions to OPDP.
• Drives and contributes to process improvements in Advertising and Promotion regulatory areas.

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 OR
  • Bachelor’s 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.
• 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 OR
  • Bachelor’s 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.
• For all levels:
  • In-depth knowledge of FDA regulations and their interpretation relevant to prescription drug advertising, promotion, and labeling.
  • Direct experience interacting with FDA OPDP.
  • Ability to influence without direct authority.

Work Arrangements

This is a hybrid role requiring the candidate to work the majority of the week in the Monmouth Junction, NJ office.

Pay

Anticipated salary range:

• Associate Director: $160,000 to $180,000 per year.
• Director: $185,000 to $230,000 per year.

Base salary is contingent on assessment of the candidate’s education and experience relative to the position’s requirements, as well as a review of related industry standards and internal equity.

Benefits

In addition to base salary, full-time employees are eligible for:

• Bonus incentives.
• Medical, dental, vision, and prescription insurance.
• 401K with company match.
• Life insurance.
• Paid company holidays and PTO.
• Paid volunteer time.
• Employee Resource Groups.