Specialist, Regulatory Affairs Advertising & Promotion Review Job at BioSpace, I

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 important 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. 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, FDA regulations and guidance, PhRMA principles and company policies Provides authoritative regulatory advice on promotional content, evaluates 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 manages 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 Bachelor’s 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. #J-18808-Ljbffr