Senior Regulatory Advertising & Promotion Associate

California, US residents click here.

The job details are as follows:

Who We Are

We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs.
 

United Therapeutics (Nasdaq: UTHR) seeks to travel down the corridors of indifference to develop treatments for rare, deadly diseases. We were founded in 1996 by a family seeking a cure for their daughter’s pulmonary arterial hypertension (PAH). Today, we have six FDA-approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF).
 

The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an organ transplant, but only a small percentage of donated organs are available to address the vast need. For this reason, we are working to create manufactured organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant. We believe an unlimited supply of tolerable, transplantable organs will eliminate the transplant waiting list and cure end-stage organ diseases for which transplant is not currently an option.
Who You Are

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.
 

• 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

Minimum 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

Preferred Qualifications

• 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

Job Location

This role is based in our Durham, NC office. Currently this job is a hybrid role requiring at least four days per week in the office. In office requirements could increase based on business needs.

At United Therapeutics, our mission and vision are one. We use our enthusiasm, creativity, and persistence to innovate for the unmet medical needs of our patients and to benefit our other stakeholders. We are bold and unconventional. We have fun, we do good.

Eligible employees may participate in the Company’s comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities

United Therapeutics  Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities.