Associate Director, Regulatory Affairs, Advertising and Promotion - Job ID: 1690

Role Summary

Associate Director Regulatory Affairs, Advertising and Promotion – internal expert on U.S. FDA regulations governing the promotion of prescription drug and biologic products. Responsible for providing commercial regulatory strategy to enable the US business to meet its commercial needs in a compliant manner.

Responsibilities

• Independently review/approve promotional, medical, payor, corporate, and other non-promotional materials to assess for regulatory compliance with applicable regulations, guidance documents, and internal policies/best practices
• Collaborate with Medical, Legal, Commercial, and Compliance to execute and approve key Commercial campaigns. Provides appropriate guidance to help evaluate and mitigate potential risk.
• Present to senior management and cross-functional teams regarding shared learnings from FDA advisory comments, recent enforcement actions, and/or guidance documents.
• Advise cross-functional stakeholders on the commercial regulatory impact of new campaign concepts, target, or product labeling, and provide strategic regulatory guidance on corporate communications and appropriate pre-approval and/or disease education communications
• Serve as the company's regulatory liaison to the FDA‚Äôs Advertising and Promotional Labeling Branch and Office of Prescription Drug Promotion for respective product(s) and ensure materials are submitted to FDA via 2253.
• Support metrics to measure and track the effectiveness and efficiency of the promotional review process and provide recommendations for process improvements to address potential issues.
• Provide commercial regulatory support to high-volume brands or therapeutic areas and projects without managerial oversight, as appropriate.
• Operate independently, with recognition of when to consult departmental senior leadership to identify and escalate risks.
• Design and deliver targeted trainings for cross-functional brand teams and senior leaders on U.S. ad promo regulations (e.g., OPDP expectations), emerging guidances, and enforcement trends; proactively identify and close knowledge gaps.

Qualifications

• Degree in life science or equivalent. Advanced degree (PharmD, PhD, MS, MBA, JD) preferred.
• Minimum of 8 years‚Äô experience in drug, biologic and/or combination products in Regulatory Affairs or related field.
• Minimum of 5 years of experience in Regulatory Affairs promotion and advertising working with prescription drug, biologic, and/or combination products.
• Experience managing major regulatory filing(s) to the FDA Office of Prescription Drug Promotion (e.g., launch advisory comment submission or responses to enforcement letters) or competitor complaints. Launch experience is a plus.
• Proven experience serving as the independent regulatory reviewer for promotional materials of a drug or biologic with extensive market visibility and a high volume of promotional activity
• Proven ability to navigate labeling negotiations with the FDA while collaborating closely with internal regulatory colleagues and cross-functional partners to align on strategy and execution
• Demonstrated skill in evaluating potential regulatory risk within promotional materials and effectively communicating those risks in a clear, actionable manner to PRC stakeholders and cross-functional marketing partners
• Maintain current knowledge of applicable government regulations, particularly those related to advertising and promotion. Knowledge of historical enforcement actions and can use this when offering recommendations to stakeholders.
• Demonstrated leadership skills. Ability to manage and bring working teams together for common objectives.
• Excellent oral and written skills, timeline responsibilities.
• Prior experience with an EDMS required, preferably Veeva Promomats and RIM.
• Ability to travel to various meetings including overnight trips. Some international travel may be required.
• Requires up to 20% travel.

Skills

• Regulatory affairs leadership
• FDA advertising and promotional labeling compliance
• Strategic regulatory guidance
• Cross-functional collaboration
• Risk assessment and mitigation
• Regulatory submissions and negotiations

Education

• Degree in life sciences required; advanced degree preferred