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Our Team, Your Impact

The Director of Regulatory Affairs, Advertising and Promotion (Ad Promo) leads the regulatory review, strategy, and approval of promotional and non-promotional communications for assigned marketed and development products, serves on the Promotion and Advertising Review Committees (PARC) and Medical Legal Regulatory (MLR) Review Committees, provides expert guidance on FDA OPDP requirements and enforcement trends, and partners cross-functionally with Commercial, Medical, Legal, and other functions to ensure that all product communications are scientifically accurate, balanced, truthful and non-misleading, and compliant with applicable regulations while supporting business objectives.

How You’ll Spend Your Day

• Serve as the regulatory reviewer for promotional and educational materials across assigned products, including HCP-directed materials (detail aids, journal advertising, congress materials, disease state education), DTC materials (television, digital, print, social media), payer-focused materials (AMCP dossiers, budget impact tools), and internal training materials.
• Chair the PARC review meetings, providing regulatory judgment on claims substantiation, fair balance, indication accuracy, safety information presentation, and consistency with approved labeling.
• Make regulatory approval decisions on promotional materials within delegated authority, and escalate contentious or precedent-setting matters appropriately to senior regulatory leadership.
• Develop and maintain review standards, templates, and precedent documentation to help ensure consistency across the promotional review portfolio.
• Provide strategic Ad Promo counsel to Commercial leadership on marketing campaigns, launch planning, competitive positioning, and lifecycle management initiatives.
• Advise on regulatory implications of proposed claims, messaging, and promotional strategies, including risk assessment and mitigation approaches for aggressive positioning.
• Partner with the launch planning team and Regulatory Operations on promotional strategy for pipeline products approaching approval, including pre-approval communication planning, launch materials development, and initial 2253 submission strategy.
• Guide the organization on emerging regulatory issues including OPDP enforcement trends, industry PhRMA Code updates, guidance implementation, and competitor labeling and promotional developments.
• Represent Regulatory Affairs in cross-functional strategic planning, brand planning, and lifecycle management forums.
• Oversee Form FDA 2253 submissions for all promotional materials within assigned scope, ensuring timely and complete submissions consistent with FDA electronic submission requirements (eCTD via ESG).
• Serve as primary or supporting regulatory contact for FDA Office of Prescription Drug Promotion (OPDP) correspondence, including responses to untitled letters, warning letters, advisory comments, and information requests.
• Lead or contribute to Advisory Comment requests to OPDP on novel or high-risk promotional concepts.
• Manage OPDP engagement strategy for assigned products, including pre-submission consultations on unusual promotional formats.
• Partner closely with Commercial leadership (Brand Directors, Marketing VPs) as the senior regulatory voice on their business.
• Work in close alignment with Medical Affairs on the promotional/non-promotional distinction, medical information and scientific exchange activities, and the appropriate use of clinical data in promotional context.
• Collaborate with Legal and Compliance on false advertising, competitive challenges, and enforcement-related matters.
• Coordinate with RA Labeling on the relationship between promotional claims and approved product labeling, including proactive labeling changes to support promotional objectives.
• Partner with Regulatory Operations to support PARC review and training activities and 2253 submissions.
• Contribute to the development and maintenance of company-wide promotional review policies, SOPs, and review standards.
• Monitor industry associations (e.g., PhRMA, DIA, RAPS Ad Promo groups) and regulatory developments affecting promotional practice.
• Lead or contribute to internal training programs for Commercial, Medical Affairs, and other stakeholders on regulatory requirements for promotional activities.
• Support regulatory inspections and audits related to promotional activities and 2253 submissions.

Your Skills and Experience

• Bachelor’s degree required in life sciences, pharmacy, or related field; advanced degree (PharmD, MS, PhD) strongly preferred.
• 8-10 years of pharmaceutical or biotechnology regulatory affairs experience, with at least 6 years specifically in Advertising and Promotion review.
• Demonstrated experience leading promotional review for multiple marketed products, including at least one product launch.
• Deep working knowledge of FDA regulations governing pharmaceutical promotion, including 21 CFR 202, 21 CFR 314.81, Section 502(n) of the FDCA, and current OPDP guidance documents.
• Substantive experience with Form 2253 submissions and current eCTD/ESG submission requirements.
• Prior direct interaction with FDA OPDP through submissions, correspondence, or advisory comment requests.
• Experience across multiple promotional channels including HCP-directed materials, DTC advertising, digital and social media, congress presence, and payer communications.
• Expert-level understanding of FDA promotional regulation, OPDP enforcement patterns, and industry standards for promotional review.
• Strong grasp of clinical trial design, statistical interpretation, and pharmacology relevant to claims substantiation.
• Working knowledge of related regulatory frameworks including PhRMA Code, FTC advertising standards, state prescriber gift laws, and Sunshine Act requirements.
• Familiarity with international promotional regulations (EMA, EFPIA, ABPI) sufficient to support global campaign coordination.
• Working knowledge of promotional review technology platforms (Veeva Vault PromoMats, Zinc MAPS, or similar).
• Excellent written and verbal communication skills, including the ability to explain complex regulatory issues to non-regulatory audiences.
• Strong analytical judgment, including the ability to distinguish material regulatory risk from stylistic preference in promotional review.
• Demonstrated ability to clearly and persuasively convey regulatory guidance while preserving productive working relationships.
• Track record of managing multiple competing priorities in a fast-paced environment.

Also Good to Have

• Direct launch experience in a therapeutic area relevant to the company's portfolio.
• Experience with novel promotional formats including digital-first campaigns, patient-facing platforms, telehealth partnerships, and interactive promotional media.
• Experience navigating high-visibility enforcement matters (warning letters, corrective advertising, consent decrees).
• Prior experience at FDA (particularly OPDP or CDER) or as a former FDA consultant.

Salary Range

How We’ll Take Care of You

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