Director, Promotional Review & Labeling Services

ProPharma•Raleigh, NC

1d•Remote

About The Position

The Director, Promotional Review & Labeling Services provides compliant, accurate regulatory affairs guidance for promotional and advertising review while helping marketing teams develop competitive materials for consumers, healthcare providers, and managed care. The role leads the Regulatory function in Promotion Review Committee (PRC) meetings and oversees promotional review and related processes for assigned brands or therapeutic categories. It reviews launch, growth, established-brand, derivative, promotional, and non-promotional materials; advises on risk and escalates risk when needed; and provides regulatory direction on campaigns, launch strategies, review planning, and timing. The Director evaluates opportunities for materials to remain consistent with FDA-approved labeling, clarifies and represents regulatory comments during PRC meetings, and communicates relevant review outcomes to the broader regulatory team. The role partners with job owners, agency partners, regulatory teams, and other stakeholders on promotional submissions to OPDP, job reapprovals, and activities related to label changes. It also monitors the US promotional regulatory environment and reviews enforcement and warning letters from relevant government and advertising bodies. The position may include attending industry and FDA meetings and performing other duties as assigned. ProPharma supports remote work, while encouraging employees who live within a reasonably short commute of an office to work hybrid for some in-person collaboration, as agreed with their manager.

Requirements

Bachelor's degree in Medical, Science, Marketing, Business, or Communications.
At least 7 years of related experience in the pharmaceutical or biotech industry; related healthcare advertising agency experience may be considered.
Functional experience in regulatory advertising and promotion.
Strong project and process management experience.
Ability to work independently and collaborate effectively with clients and team members while working remotely.
Ability to provide strategic, forward-thinking regulatory guidance and analyze and interpret efficacy and safety data.
Working knowledge of FDA and pharmaceutical regulatory and compliance guidelines for advertising and promotion, including product launches.
Deep understanding of the advertising and creative development process and the pharmaceutical review and approval process.
Experience leading activities required for promotional OPDP submissions.
Experience using new and social media platforms to promote prescription drugs in the US.
Proficiency with computer applications, including Microsoft Office and Adobe Acrobat, and with Veeva Vault PromoMats or other electronic review platforms.

Nice To Haves

PharmD.
Previous experience in medical advertising and promotional review, marketing operations, sales, or communications.
Strong project and process management experience in the pharmaceutical industry.
Product launch or advertising agency account management experience.

Responsibilities

Provide compliant and accurate regulatory affairs solutions for advertising and promotional review, while supporting competitive materials for consumer, healthcare provider, and managed-care audiences.
Lead the Regulatory role in Promotion Review Committee meetings and oversee promotional review and related processes for assigned brands or therapeutic categories.
Review product-launch, growth-brand, established-brand, derivative, promotional, and non-promotional materials for assigned projects.
Advise the PRC on risk and escalate risk to the appropriate manager or client line manager when necessary.
Review and approve materials for assigned PRCs using a strong understanding of regulatory advertising and promotion requirements and FDA guidance.
Attend prioritization discussions for assigned PRCs.
Evaluate opportunities for materials to be consistent with FDA-approved labeling.
Provide regulatory guidance on advertising and promotional materials, campaigns, and launch strategies.
Counsel job owners on review planning, including timing, review type, and relevant guidance documents.
Communicate information from promotion review meetings to the broader regulatory team when appropriate.
Explain the rationale for regulatory comments and represent those comments during live PRC meetings.
Work with agency partners and Regulatory or Regulatory Operations Managers on initial-use promotional submissions to OPDP using Form FDA 2253.
Partner with job owners and other stakeholders on job reapprovals and tactics related to label changes for assigned brands.
Monitor US promotional regulations and guidance, and review relevant untitled and warning letters issued by OPDP, APLB, CDRH, the FTC, the National Advertising Division, or other governing bodies.
Attend major FDLI, DIA, and other industry or FDA meetings as appropriate.
Perform other duties as assigned.