Specialist, Regulatory Affairs Advertising & Promotion Review
Tris Pharma, Franklin Park, NJ, United States
Tris Pharma, Inc. (www.trispharma.com) is a leading privately‑owned U.S. biopharmaceutical company focused on the development and commercialization of innovative medicines for ADHD, spectrum disorders, anxiety, pain, and addiction. With over 150 U.S. and international patents, we market several branded ADHD products in the U.S., license products in U.S. and ex‑U.S. markets, and maintain a robust pipeline spanning neuroscience and other therapeutic categories that employs our proprietary science and technology.
We have an opening at our Monmouth Junction, NJ facility for a Specialist in Regulatory Affairs Advertising & Promotion Review. This role will partner closely with the Head of Regulatory Affairs Advertising & Promotion to perform regulatory review of advertising and promotional activities across the business, ensuring compliance with regulatory requirements and driving strategic promotional initiatives. The incumbent will leverage 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.
Essential Functions
Lead regulatory reviews of external communications intended for healthcare professionals, patients, and caregivers, ensuring high‑quality, accurate, and compliant content aligned with U.S. laws, FDA regulations and guidance, PhRMA principles, and company policies.
Provide authoritative regulatory advice on promotional content, evaluate promotional claims, and develop compliant strategies in collaboration with Commercial, Medical, and other relevant teams.
Ensure product promotion materials are consistent with FDA‑approved labeling and effectively manage related submission processes.
Oversee timely and accurate submissions of promotional materials using FDA Form 2253.
Establish, enhance, and streamline regulatory review processes, promoting best practices and operational excellence.
Act as a regulatory subject‑matter expert in cross‑functional meetings, ensuring alignment on regulatory requirements and business goals.
Requirements
Bachelor’s degree in a life‑science field (advanced degree preferred) and minimum 2 years of pharmaceutical or biotechnology industry experience reviewing promotional and non‑promotional materials and submissions using the 2253 form to the FDA.
In‑depth knowledge of FDA regulations, U.S. promotional laws, and industry best practices.
Proven ability to analyze complex medical and scientific information and apply regulatory principles.
Proficiency with regulatory submission tools.
Work Arrangements : We are a hybrid work environment requiring candidates to work the majority of each week in our NJ office.
Anticipated salary range : $100 to $140K per year. Base salary is contingent on assessment of candidate’s education and experience relative to the position requirements and industry standards.
Additional benefits : In addition to base salary, full‑time employees are eligible for incentives including bonus, medical, dental, vision, Rx insurance, 401(k) 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. To build and enhance our diverse workforce, we encourage applications from individuals with disabilities, minorities, veterans, women, LGBTQ, etc. Tris Pharma, Inc. is an Equal Opportunity Employer.
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We have an opening at our Monmouth Junction, NJ facility for a Specialist in Regulatory Affairs Advertising & Promotion Review. This role will partner closely with the Head of Regulatory Affairs Advertising & Promotion to perform regulatory review of advertising and promotional activities across the business, ensuring compliance with regulatory requirements and driving strategic promotional initiatives. The incumbent will leverage 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.
Essential Functions
Lead regulatory reviews of external communications intended for healthcare professionals, patients, and caregivers, ensuring high‑quality, accurate, and compliant content aligned with U.S. laws, FDA regulations and guidance, PhRMA principles, and company policies.
Provide authoritative regulatory advice on promotional content, evaluate promotional claims, and develop compliant strategies in collaboration with Commercial, Medical, and other relevant teams.
Ensure product promotion materials are consistent with FDA‑approved labeling and effectively manage related submission processes.
Oversee timely and accurate submissions of promotional materials using FDA Form 2253.
Establish, enhance, and streamline regulatory review processes, promoting best practices and operational excellence.
Act as a regulatory subject‑matter expert in cross‑functional meetings, ensuring alignment on regulatory requirements and business goals.
Requirements
Bachelor’s degree in a life‑science field (advanced degree preferred) and minimum 2 years of pharmaceutical or biotechnology industry experience reviewing promotional and non‑promotional materials and submissions using the 2253 form to the FDA.
In‑depth knowledge of FDA regulations, U.S. promotional laws, and industry best practices.
Proven ability to analyze complex medical and scientific information and apply regulatory principles.
Proficiency with regulatory submission tools.
Work Arrangements : We are a hybrid work environment requiring candidates to work the majority of each week in our NJ office.
Anticipated salary range : $100 to $140K per year. Base salary is contingent on assessment of candidate’s education and experience relative to the position requirements and industry standards.
Additional benefits : In addition to base salary, full‑time employees are eligible for incentives including bonus, medical, dental, vision, Rx insurance, 401(k) 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. To build and enhance our diverse workforce, we encourage applications from individuals with disabilities, minorities, veterans, women, LGBTQ, etc. Tris Pharma, Inc. is an Equal Opportunity Employer.
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