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Lead Regulatory Affairs Promotional Review Specialist
2 months ago
Company Overview
ProPharma Group has dedicated the last two decades to enhancing patient health and wellness by offering expert guidance that empowers organizations in biotechnology, medical devices, and pharmaceuticals to confidently navigate scientific advancements and launch innovative therapies.
Position Summary
The Senior Regulatory Promotional Review Consultant plays a crucial role in ensuring compliance and accuracy in promotional and advertising materials from a regulatory perspective. This position collaborates closely with marketing teams to deliver competitive solutions for consumer, healthcare provider, and managed care communications across various brands.
Key Responsibilities
- Serve as the primary regulatory representative during Promotion Review Committee (PRC) meetings, overseeing the promotional review process for assigned brands or therapeutic categories.
- Evaluate and review promotional materials for product launches, growth brands, established brands, and derivative projects.
- Provide risk assessments to the PRC and escalate concerns to management when necessary.
Essential Functions
- Review and approve all promotional and non-promotional materials, ensuring a strong understanding of regulatory advertising and promotion guidelines, including FDA regulations.
- Participate in prioritization discussions for the assigned PRC and assess opportunities consistent with FDA-approved labeling.
- Offer regulatory guidance on advertising materials, new campaigns, and launch strategies.
- Advise job owners on the review process, including timing and necessary documentation.
Collaboration and Communication
- Communicate insights from promotion review meetings to the broader regulatory team as appropriate.
- Clarify and represent regulatory feedback during live PRC meetings.
- Collaborate with Agency Partners and Regulatory Operations Managers for the submission of promotional materials to the Office of Prescription Drug Promotion (OPDP).
Monitoring and Compliance
- Stay informed on the US regulatory promotional landscape by keeping up-to-date with FDA regulations and guidance.
- Review untitled and warning letters issued by regulatory bodies such as OPDP and the Federal Trade Commission (FTC).
Qualifications
- A Bachelor's degree in Medical, Science, Marketing, Business, or Communications is required; a PharmD is preferred.
- A minimum of 7 years of relevant experience in the pharmaceutical or biotech industry is essential, with a focus on regulatory advertising and promotion.
- Strong project management skills and experience in the pharmaceutical industry are preferred.
Diversity and Inclusion
ProPharma Group is committed to fostering a diverse and inclusive workplace where every employee can thrive and contribute their unique perspectives. We celebrate our differences and encourage innovative, collaborative, and entrepreneurial spirits.
