Regulatory Promotional Review Consultant

ProPharma•Raleigh, NC

1d•Remote

About The Position

The Regulatory Promotional Review Consultant provides regulatory affairs guidance and review for promotional and advertising materials, delivering compliant and accurate solutions while supporting competitive marketing materials for consumer, healthcare provider, and managed care audiences. The consultant leads the Regulatory role in Promotion Review Committee (PRC) meetings and oversees promotional review and related processes for assigned brands or therapeutic categories. The role reviews and approves promotional and non-promotional materials, advises on regulatory risk and advertising and promotion requirements, and supports product launches, brand growth, established brands, and derivative materials. The consultant works with job owners, agency partners, regulatory teams, and other stakeholders on review planning, OPDP submissions, reapprovals, label changes, and launch strategies. This is a part-time consultant role. ProPharma supports remote work, while encouraging employees located within a reasonably short commute of an office to work on a hybrid basis as agreed with their manager.

Requirements

Bachelor’s degree, with a focus in Medical, Science, Marketing, Business, or Communications.
At least 5 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 flexibly, and to collaborate 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 necessary for promotional OPDP submissions.
Experience using new and social media platforms to promote prescription drugs in the US.
Proficiency with Microsoft Office, Adobe Acrobat, and Veeva Vault Promo Mats or other electronic review platforms.

Nice To Haves

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

Responsibilities

Review and approve promotional and non-promotional materials for assigned Promotion Review Committees, applying regulatory advertising and promotion regulations and FDA guidance.
Lead the Regulatory role during PRC meetings, oversee the promotional review process, and clarify the rationale for regulatory comments.
Attend prioritization discussions for assigned PRCs.
Review product launch, growth brand, established brand, and derivative materials for assigned projects.
Evaluate opportunities to ensure materials are consistent with FDA-approved labeling.
Provide regulatory guidance on advertising and promotional materials, campaigns, and launch strategies.
Advise job owners on review planning, timing, review types, and relevant guidance documents.
Communicate information from promotion review meetings to the broader regulatory team when appropriate.
Interact with agency partners and regulatory or regulatory operations managers to submit promotional materials to OPDP for initial use using Form FDA 2253.
Partner with job owners and stakeholders on job reapprovals and tactics related to label changes for assigned brands.
Monitor the US regulatory promotional environment and stay current on FDA regulations and guidance.
Review untitled and warning letters issued by OPDP, APLB, CDRH, FTC, NAD, and other governing bodies.
Attend major FDLI, DIA, and other industry or FDA meetings as appropriate.