Associate Director, Global Regulatory Affairs-Advertising and Promotion Review Lead

Role Summary

Associate Director, Global Regulatory Affairs Advertising and Promotion Review Lead. Supports the Oncology Portfolio as the internal expert on US Codes, guidance, and industry standards pertaining to prescription medicine promotion.

Responsibilities

• Serve as GRA A&P SME for assigned products and projects.
• Regulatory advisor in the core Medical, Legal, Regulatory review functions of the Commercial Material Review Process (CMRP) and Medical Material Review Process (MMRP) for both Commercial and Medical material development, review, approval, and implementation.
• Product or project business lead for global CMRP at Takeda.
• CMRP Meeting Chair‚Äîcommunicate comments to coordinator, diffusing team disputes, negotiating, and overseeing escalation steps if alignment is not reached or new data/campaigns require senior input.
• Strategic business partner from clinical trial development through the marketing maintenance phase of a product lifecycle.
• Subject matter expert on FDA code/regs, guidance, industry standards, complaints/violations, and innovative promotional platforms with additional training on International Codes (e.g., EFPIA, IFPMA).
• Partner closely with line-management, Oncology GRA A&P Portfolio Lead, and inform or bring in Head of GRA A&P for complex review concepts or topics.
• Empowered decision-maker within the CMRP.

Qualifications

• Bachelor's Degree in a science-related field is required.
• Master's Degree preferred. Minimum of 3 years‚Äô experience required in material review and approval process of pharmaceutical/biologics promotion.
• Ability to understand ABPI, EFPIA and other international code and guidance about advertising and promotion for prescription medicines.
• Experience in prescription medicine promotion development and review process.
• Strong interpersonal skills with ability to demonstrate strategic and analytic thinking.
• Demonstrated ability to communicate clearly and concisely.
• Highly effective written and verbal communication skills to manage, motivate and drive decisions within teams.
• Proven skills in negotiation, influencing without authority and working diplomatically through conflict.
• Demonstrated cross-functional people management with a desire to foster a positive team culture.
• Ability to work independently, take initiative and complete tasks to deadlines.
• Previous experience in an advertising and promotion role.

Skills

• Regulatory affairs expertise in advertising and promotion
• FDA code/regs knowledge; international codes (EFPIA, IFPMA)
• Strategic thinking and project leadership
• Negotiation and conflict resolution
• Cross-functional collaboration