Job Description
Title: Senior Director Regulatory Advertising & Promotion
A pioneering biopharma is looking to grow the legal team with a Senior Director Regulatory Advertising & Promotion to support their new product launch. This will be a hands-on position, serving as a high level operational and strategic lead in complying with regulatory guidelines. This person will lead the design and implementation of systems to ensure promotional and non promotion materials are compliant for marketed and emerging products.
Responsibilities:
- Provide regulatory strategic oversight for multiple therapeutic areas and products to ensure regulatory compliance of promotional and non-promotional materials generated for external communication regarding commercialized products and/or compounds in development.
- Understand and interpret complex regulatory requirements applicable to use of product and disease-related communications by pharmaceutical companies.
- Serve as the chair of review meetings overseeing approval of externally-facing content designed to communicate promotional and non-promotional messages regarding commercialized products and products in development.
- Mentor and develop staff and subject matter expertise by providing training and regular updates on existing and new regulatory requirements.
- Serve as primary liaison with Regulatory Affairs for communications with OPDP and/or APLB reviewers in the request and negotiation of advisory comments and any other interactions regarding use of promotional claims for FDA-approved products.
- Ensure efficient and consistent application of our materials review system to operationalize and document collaborative review/approval by subject matter experts of materials related to disease areas, commercialized products, and product development efforts.
- Develop and update standard operating procedures for materials content review and approval.
- Support metrics to measure and track the effectiveness and efficiency of the materials content review process and provide recommendations for process improvements to address potential issues.
- Collaborate with Regulatory Affairs, Medical, Legal, Commercial, Ad Agencies, and Compliance to ensure alignment and effective execution of corporate objectives while mitigating potential regulatory compliance risk.
- Serve as an internal expert on FDA regulations, guidance, and enforcement trends governing the promotion of prescription drug products and communication of scientific and other information regarding company products and therapeutic endeavors.
- Proactively identify regulatory compliance issues related to use of proposed promotional and non-promotional materials and offer creative risk mitigation solutions.
- Collaborate with the Regulatory team to provide product and label development strategies, as needed, to ensure promotional campaigns can be supported.
- Collaborate with the International Regulatory Ad/Promo review team(s)/advisors for materials that are intended for global audiences (e.g., global press releases, new global campaigns, conference booth presence).
Preferred Skills, Qualifications, and Technical Proficiencies:
- Previous leadership experience in oversight of regulatory compliance (e.g., PRC or MLR Chair) regarding product promotion, advertising, and other communications related to pharmaceutical product development, including communications with formulary committees and similar bodies.
- Extensive knowledge of applicable regulations and regulatory guidance specific to advertising and promotion of pharmaceutical products for healthcare professionals, payors, and consumer audiences.
- Experience managing major regulatory filing(s) (e.g., launch advisory comment submission or responses to enforcement letters) or competitor complaints.
- Ability to provide regulatory leadership and guidance to commercial and drug development teams, merging scientific principles and FDA law and regulations in development of marketing materials and disease awareness campaigns.
Preferred Education and Experience:
- BA/BS Degree in health/life sciences or related field.
- Advanced degree (PharmD, PhD, MS) preferred.
- 12+ years of Regulatory Ad/Promo experience in pharmaceuticals
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