Associate Director, Regulatory Labeling Promotional Review
Omega Management Group
Bridgewater area, NJ
The Associate Director, Regulatory Labeling and Promotional Review will provide strategic regulatory advice on advertising and promotional materials and activities in accordance with business goals and objectives, Food and Drug Administration (FDA) regulations & guidance, Pharmaceutical Research and Manufacturers of America (PhRMA) guidelines, and company policy. This position will participate in negotiations with FDA’s OPDP for assigned products and will develop a strong and positive working relationship with the Office of Prescription Drug Promotion (OPDP) reviewers. This position will manage OPDP queries by working with the Brand Team and Regulatory senior director. This position will apply regulatory and therapeutic area knowledge to the Brand Team's objectives and initiatives in order to develop solutions for complex US promotional issues, and ensure regulatory compliance while effectively managing business risks. They will also be responsible for monitoring the US regulatory environment by reviewing regulatory promotional guidelines, untitled and warning letters to pharmaceutical companies published by OPDP, and by attendance at industry/FDA meetings on labeling and promotional review topics. The Associate Director will participate in US labeling negotiations and FDA meetings as necessary, ensuring that any changes in the US package insert are reflected in current materials.
- Review and approve all advertising and promotional materials, concept reviews and pre-commercialization materials for assigned products in collaboration with commercial, clinical & medical affairs, and legal to ensure that they comply with FDA regulations. Serve as liaison with OPDP for assigned marketed products to facilitate the FDA review of advertising and promotional materials (e.g. launch materials submitted for advisory comment).
- Develop, implement, and maintain regulatory procedures regarding review of advertising and promotional materials for marketed products and pre-commercialization materials for products or uses prior to FDA-approval. Oversee the management of a paper and/or electronic control system to track all copy through the approval and production process, ensuring that materials are kept current and that expired materials are destroyed or are re-certified for continued use.
- Maintain up to date information regarding initiatives by FDA and other applicable regulatory authorities related to labeling and review of advertising and promotional materials. Monitor and communicate updates on new FDA guidance, the issuance of enforcement letters by OPDP and other Company or competitor product FDA correspondence to internal stakeholders.
- Lead cross-functional teams in the development and lifetime maintenance of core and regional prescribing information and other regional labeling for assigned products. Represent labeling group on product sub-teams, communicate key strategies, and ensure labeling positions are appropriately represented. Develop and manage approval of the content of prescribing information through the creation, maintenance, and revision of United States Package Inserts (USPI).
- Work with Commercial, Manufacturing, Quality Assurance groups to ensure that all labeling is in conformance with FDA or other health authority approvals prior to commercial printing.
BS or advanced degree (PharmD, PhD) in a scientific discipline
-5-7 years in Regulatory, R&D or related area within Pharma/Biotech industry, of which 3-5 years were spent recently managing US labeling and promotional review activities for small molecules and/or biologics
-An excellent understanding of and ability to apply current US labeling regulations and guidelines
-Proven experience in leading activities necessary for promotional OPDP submissions (including pre-clearance and 2253, “time of first use” submissions)
-Solid knowledge of drug development process and demonstrated ability to apply regulatory guidelines pertaining to product labeling and ICH guidelines, including interpretation of efficacy and safety data
-Demonstrated strong leadership, project management, problem solving, strategic thinking, negotiation, interpersonal and communication skills (both written and oral) with attention to detail and ability to work under tight timelines
Supervisory Experience: Preferred
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