Specialist, Regulatory Affairs Advertising & Promotion Review

We have an opening in our Monmouth Junction, NJ facility for an experienced Specialist, Regulatory Affairs Advertising & Promotion Review to join our Regulatory Affairs team.

The incumbent will partner closely with the Head of Regulatory Affairs Advertising & Promotion to perform regulatory review in support of advertising and promotional activities across the business and cross-functional teams and to ensure compliance with regulatory requirements while driving strategic promotional initiatives. She/he leverages extensive pharmaceutical and regulatory experience to manage complex projects, provides expert guidance and contributes to continuous improvement of regulatory affairs advertising and promotion review processes.

ESSENTIAL FUNCTIONS

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, Food and Drug Administration (FDA) regulations and guidance, Pharmaceutical Research and Manufacturers of America (PhRMA) principles and company policies

Provides authoritative regulatory advice on promotional content, evaluate 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 manage 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

REQUIREMENTS

Bachelors degree in a life‑science field (advanced degree preferred) and minimum 2 years 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, US 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 majority of every week in our NJ office.

Anticipated salary range: $100 to $140K/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: In addition to base salary, full‑time employees are also eligible for incentives, including, but not limited to: bonus eligible, 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. 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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