Lead Reviewer, Regulatory Affairs Advertising & Promotion
Company: Tris Pharma
Location: Monmouth Junction
Posted on: January 26, 2026
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Job Description:
Tris Pharma, Inc. (www.trispharma.com) is a leading
privately-owned U.S. biopharmaceutical company with a focus 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 also license
our products in the US and ex-US markets. We have a robust pipeline
of innovative products spanning neuroscience and other therapeutic
categories employing our proprietary science and technology. Our
science and technology make us unique, but our team members set us
apart; they are the engine fueling Tris’ passion and innovation.
Our colleagues understand the criticality of operating a successful
business and take pride in the company’s success. Equally
importance to each team member is how we interact with one another
on a daily basis. We believe in each other and in respectful, open
and honest communications to help 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. Incumbent leads
regulatory review efforts supporting advertising and promotional
activities across the business. The incumbent partners closely with
the Head of Regulatory Affairs Advertising & Promotion and
cross-functional teams 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 REQUIREMENTS 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 Work Arrangements: 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: 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. LI-hybrid
Keywords: Tris Pharma, Camden , Lead Reviewer, Regulatory Affairs Advertising & Promotion, Science, Research & Development , Monmouth Junction, New Jersey
