Associate Director, Regulatory Affairs Advertising & Promotions
New Jersey, USA (Hybrid)
Posted 7 weeks ago
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Job Description
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
Tris Pharma Inc
Tris Pharma, Inc. is a leading privately-owned biopharmaceutical company in the U.S. Our focus is on the development and commercialization of innovative medicines that address unmet patient needs and we have more than 150 U.S. and International patents including applications. We market several branded and generic products in the U.S; license our products in the U.S. and international markets and we have a robust pipeline of innovative products, that employ our proprietary science and technology, to meet patients’ needs in neuroscience and other therapeutic categories. Our science and technology make us unique, but it is our team members that set us apart; they are the engine that fuels Tris’ passion and innovation. The Tris team comprises of approximately 500 diverse individuals; one third of whom operate in the field throughout the U.S. while the other two-thirds work from Tris’ NJ operations. Tris colleagues understand the criticality of operating a successful business and take pride in the company’s success. But of equal importance to each member of the team is how we interact with one another on a daily basis. We believe in each other and we believe in respectful, open and honest communications to help support individual and team success. At Tris, we strive to ensure our field and home office teams are connected and engaged. We listen to our teams in numerous ways, including through our Diversity & Inclusion Committee and our Women’s Business Council, to help ensure every employee’s voice is heard. After all, it is our daily interactions with one another that build and sustain our culture, which fuels our growth.
