Specialist, Regulatory Affairs Advertising & Promotion Review

About the position 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 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.

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

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 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

Benefits

• bonus eligible
• medical
• dental
• vision
• Rx insurance
• 401K with match
• life insurance
• paid Company Holidays
• PTO
• Paid Volunteer Time
• Employee Resource Groups