Associate Director, Regulatory Affairs Advertising & Promotions

Description Tris Pharma, Inc. (www.trispharma.com) is a leading privately-owned US biopharmaceutical company focused 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 US. We also license our products in the US and ex-US markets. Our robust pipeline of innovative products employing our proprietary science and technology spans neuroscience and other therapeutic categories. Our science and technology make us unique, but our team members set us apart; they’re 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 is how we interact on a daily basis. We believe in each other and in respectful, open and honest communication to help support individual and team success. We have an opening in our Monmouth Junction, NJ office for an experience Associate Director, Advertising & Promotions to join our Regulatory Affairs team. The Associate Director, Regulatory Affairs Advertising and Promotions provides senior regulatory oversight for the review and approval of promotional materials and related external communications for products. Reporting to the Head, Regulatory Affairs Advertising and Promotion, the incumbent helps ensure materials are accurate, balanced, substantiated, consistent with Food and Drug Administration (FDA) approved labeling and compliant with applicable FDA regulations, guidance, industry standards and company policies. She/he supports compliant business execution by providing strategic regulatory advice, leading complex promotional reviews, managing FDA submission requirements and improving review processes. The incumbent serves as secondary company contact to the FDA Office of Prescription Drug Promotion (OPDP) and helps ensure materials are submitted to the FDA in an accurate, compliant and timely manner to meet company goals. Requirements Primary duties/responsibilities Reviews and approves advertising and promotional materials ensuring compliance with applicable FDA laws, regulations and guidance documents Provides strategic input and clear regulatory advice towards the development of compliant yet competitive advertising and promotional material Key resource for regulatory advice on promotional and advertising initiatives throughout the company Maintains continued awareness and understanding of new and existing FDA regulations, guidance documents and enforcement actions regarding advertising and promotion of pharmaceutical products and communicates these to PRC and senior management, as needed Provides training regarding FDA expectations on advertising and promotion, as requested Provides strategic input on regulatory requirements for claim substantiation for desired promotional claims to enhance marketability of product portfolio Prepares and approves Form FDA-2253 submissions to OPDP Contributes to, and drives, Advertising and Promotion regulatory process improvements in relevant areas, as needed Special knowledge or skills needed and/or licenses or certificates required Bachelors degree in life sciences, pharmacy, medicine or a related discipline and minimum of 7 years’ experience as a regulatory reviewer of advertising and promotional materials in the pharmaceutical, biotechnology or related industry REQUIRED In-depth knowledge of FDA regulations and their interpretation relevant to prescription drug advertising, promotion and labeling REQUIRED Direct experience interacting with FDA OPDP REQUIRED Ability to influence without direct authority REQUIRED Work Arrangements: We are a HYBRID work environment requiring candidates to be able to work majority of week in our NJ office. Anticipated salary range: $180 to $225K/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. #LI-hybrid