Tris Pharma · 7 hours ago
Lead Reviewer, Regulatory Affairs Advertising & Promotion
Monmouth Junction, NJ
Full-time
Hybrid
Mid, Senior Level
$110K/yr - $135K/yr
4+ years expTris Pharma, Inc. is a leading privately-owned U.S. biopharmaceutical company focused on developing and commercializing innovative medicines. They are seeking an experienced Lead Reviewer in Regulatory Affairs to oversee regulatory reviews of promotional activities, ensuring compliance with FDA regulations and driving strategic initiatives.
BiotechnologyLife ScienceManufacturingMedicalPharmaceutical
Responsibilities
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
Qualification
Required
Bachelors degree in a life-science field and minimum 4 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
Preferred
advanced degree preferred
Benefits
Bonus eligible
Medical
Dental
Vision
Rx insurance
401K with match
Life insurance
Paid Company Holidays
PTO
Paid Volunteer Time
Employee Resource Groups
Company
Tris Pharma
Tris Pharma is a pharmaceuticals company providing specialty generic products.
501-1000 employees
H1B Sponsorship
Tris Pharma has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (18)
2024 (21)
2023 (20)
2022 (17)
2021 (16)
2020 (33)
Funding
Current Stage
Late StageTotal Funding
$141.6MKey Investors
National Institute on Drug Abuse (NIDA)Deerfield
2023-08-28Grant· $16.6M
2018-10-05Debt Financing· $125M
Leadership Team
Franchesca M. Fowler
General Counsel, Vice President and Chief Compliance Officer
J
James Hackworth
President, Brand Division
Recent News
Company data provided by crunchbase