Lead Reviewer, Regulatory Affairs Advertising & Promotion

Overview

Tris Pharma, Inc. is a leading privately-owned U.S. biopharmaceutical company focused on development and commercialization of innovative medicines in ADHD, spectrum disorders, anxiety, pain and addiction addressing unmet patient needs. We have >150 US and international patents and market several branded ADHD products in the U.S. We license our products in the US and ex-US markets. Our pipeline spans neuroscience and other therapeutic categories leveraging our proprietary science and technology.

Our team emphasizes respectful, open and honest communication to support individual and team success.

We have an opening in our Monmouth Junction, NJ facility for an experienced Lead Reviewer, Regulatory Affairs – Advertising & Promotion to join our Regulatory Affairs team. The incumbent leads regulatory review efforts supporting advertising and promotional activities across the business, partnering with the Head of Regulatory Affairs Advertising & Promotion and cross-functional teams to ensure compliance with regulatory requirements while driving strategic promotional initiatives.

The role leverages extensive pharmaceutical and regulatory experience to manage complex projects, provide expert guidance and contribute to continuous improvement of regulatory affairs advertising and promotion review processes.

• Leads regulatory reviews of external communications intended for healthcare professionals (HCPs), patients and caregivers, ensuring high-quality, accurate and compliant content aligned with US laws, FDA regulations and guidance, PhRMA principles and company policies
• Provides authoritative regulatory advice on promotional content, evaluates promotional claims, and develops compliant strategies in collaboration with Commercial, Medical and other relevant teams
• Ensures product promotion materials are consistent with FDA-approved labeling and effectively manages related submission processes
• Oversees timely and accurate submissions of promotional materials using FDA Form 2253
• Establishes, enhances and streamlines regulatory review processes, promoting best practices and operational excellence
• Acts as a regulatory subject-matter expert in cross-functional meetings, ensuring alignment on regulatory requirements and business goals

• Bachelors degree in a life-science field (advanced degree preferred) and minimum 4 years pharmaceutical or biotechnology industry experience reviewing promotional and non-promotional materials and submissions using the 2253 form to the FDA (REQUIRED)
• In-depth knowledge of FDA regulations, US promotional laws and industry best practices (REQUIRED)
• Proven ability to analyze complex medical and scientific information and apply regulatory principles (REQUIRED)
• Proficiency with regulatory submission tools (REQUIRED)

We are a HYBRID work environment requiring local candidates to be able to work majority of week in our NJ office.

Anticipated salary range: $110 to $135K/yr. Base salary offered is contingent on assessment of candidate’s education and experience level relative to requirements of the position and a review of related industry standards and internal equity.

Additional benefits include incentives, bonus eligibility, medical, dental, vision, Rx insurance, 401K with match, life insurance, paid company holidays, PTO, Paid Volunteer Time and Employee Resource Groups.

Tris Pharma, Inc. offers a highly competitive compensation and benefits package. We encourage applications from individuals with disabilities, minorities, veterans, women, LGBTQ, etc. Tris Pharma, Inc. is an Equal Opportunity Employer.