Senior Regulatory Advertising & Promotion Associate

United Therapeutics Corporation•RTP, NC, NC

7d•Hybrid

About The Position

The Senior Regulatory Advertising & Promotion Associate provides regulatory knowledge, scientific expertise, guidance, and risk assessments to cross-functional teams developing advertising, promotional and disease state education materials (including but not limited to marketing materials, disease education, press releases, websites, social media, speaker presentations, talking points, internal trainings, etc.), that are aligned with corporate commercialization efforts under the guidance and direction of the Ad/Promo leadership team. This position also requires timely and accurate submission of promotional materials to FDA in Form 2253 and maintaining strong relationships with internal customers; including but not limited to Commercial, Legal, and Global Medical Affairs.

Requirements

Associate degree in a relevant field, and 7+ years of experience in pharmaceutical/biotech, or Bachelor’s Degree in a relevant field, and 5+ years of experience in pharmaceutical/biotech, or Master’s Degree in a relevant field, and 3+ years of experience in pharmaceutical/biotech, or Doctor of Pharmacy (PharmD) in a relevant field, and 0+ years of experience in pharmaceutical/biotech
Ability to provide regulatory knowledge, guidance, and risk assessments to cross-functional teams
Demonstrated understanding of FDA’s submission requirements and drug/biologic/device development processes
Good oral and written communication skills
Detail-oriented, self-directed, and ability to handle multiple projects across all functional areas independently
Proficiency with Microsoft Office platforms, including Word, Outlook and PowerPoint

Nice To Haves

1+ years of experience in managing OPDP submissions
1+ years of experience in pharmaceutical advertising and promotion or related health/science field; experience with Veeva PromoMats preferred
Regulatory Affairs Certifications (RAC)-RAPS
Ability to drive accountability and responsibility that enables others to act with integrity
Experience with Veeva PromoMats
Technical knowledge in eCTD compliant submissions and experience with Veeva Vaults
Experience working directly with OPDP

Responsibilities

Act as the regulatory subject matter expert providing review, guidance, strategic advice, and approval of advertising and promotional materials for all approved products and indications, including branded and disease education materials, with minimal direction from ad/promo leadership, while collaborating cross functionally to ensure timely, accurate reviews that meet business-critical timelines and regulatory requirements
Apply extensive scientific and pharmaceutical expertise to serve as a key regulatory decision maker and advisor on the Promotional Review Board, independently evaluating, defending, and communicating regulatory comments and concerns with both the review board and commercial teams to ensure shared understanding and adherence to regulatory compliance expectations
Support critical new product and new indication launches by providing scientific and regulatory expertise on proposed claims and promotional concepts, coordinating review activities for new promotional materials, and planning and scheduling OPDP submissions to meet essential launch timelines and organizational priorities
Independently interpret and apply new or revised FDA regulations, guidances, and compliance considerations related to pharmaceutical advertising and promotion, ensuring promotional materials align with FDA and FTC requirements, assessing the evolving regulatory environment, and maintaining accountability for the regulatory integrity and compliance of all FDA-submitted promotional materials
Exercise independent judgment to determine OPDP submission requirements and ensure accurate and timely submission of advertising and promotional materials to the Office of Prescription Drug Promotion using FDA Form 2253 through the Veeva system in compliance with FDA regulations
Perform all other duties as assigned