Tris Pharma, Inc. (www.trispharma.com) is a leading privately-owned biopharmaceutical company in the U.S. with a focus on development and commercialization of innovative medicines that address unmet patient needs. We have more than 150 US and International patents including applications and have marketed several branded and generic products in the U.S., have licensed our products in the US and international markets, and 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 it is our team members that set us apart; they are the engine that fuels Tris’ passion and innovation. 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.
Our Regulatory Affairs department located in our Monmouth Junction, NJ headquarters has an immediate need for an experienced Director or SR Director, Regulatory Affairs, Advertising and Promotion (title commensurate with experience) to lead our RA Advertising and Promotional activities and manage a small, but impactful, team. This is a HYBRID role consisting of office/home working schedule.
Reporting to Head, Regulatory Affairs this position is responsible for conducting regulatory review of all advertising and promotional materials for compliance with applicable FDA regulations and guidance documents. She/he functions independently as a decision maker and subject-matter expert (SME) while working collaboratively with key stakeholders from Medical Affairs, Marketing and Legal. Selected candidate will also serve as the primary company contact to the FDA Office of Prescription Drug Promotion (OPDP) and will ensure materials are submitted to FDA in a timely manner to meet company goals. Key responsibilities include, but are not limited to, the following:
· Reviews and approves advertising, promotional materials that are compliant 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 for the company.
· Maintains continued awareness and understanding of existing and any new FDA regulations, guidance documents and enforcement actions regarding advertising and promotion of pharmaceutical products and communicates these to the Promotional Review Committee (PRC) and senior management as needed.
· Provides training regarding FDA expectations regarding advertising and promotion as requested.
· Provides strategic input on regulatory requirements for claim substantiation for desired promotional claims to enhance marketability of the product portfolio.
· Prepares and approves Form FDA-2253 submissions to OPDP.
· Drives process improvements in relevant areas.
· Bachelors degree AND minimum 8 years’ experience as a regulatory reviewer of advertising and promotional materials within the pharmaceutical industry.
· Current, in-depth knowledge of FDA regulations and their interpretation relevant to prescription drug advertising, promotion and labeling.
· Proven record of developing and maintaining successful working relationship with the FDA OPDP
· Ability to influence without direct authority
· People Management experience PLUS
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.