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

Role Summary

Associate Director, Global Regulatory Affairs Advertising and Promotion Review Lead. Support for Takeda's Oncology Portfolio as the internal expert on US Codes, guidance, and industry standards pertaining to prescription medicine promotion. Responsible for management of assigned programs/products within the CMRP/MMRP frameworks and strategic collaboration across clinical development and marketing.

Responsibilities

• Serve as GRA A&P SME for assigned products and projects.
• Regulatory advisor as the “R” 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—communicate comments, diffuse team disputes, negotiate, and escalate as needed to senior management for alignment.
• Strategic business partner from clinical trial development through the marketing maintenance phase of a product lifecycle.
• Subject matter expert on FDA codes/regulations, guidance, industry standards, complaints/violations, and innovative promotional platforms with training on International Codes (EFPIA, IFPMA) and guidelines for Global product support.
• Partner closely with line-management, Oncology GRA A&P Portfolio Lead, and inform or involve Head of GRA A&P for complex topics.
• Empowered decision-maker within the CMRP.

Qualifications

• Required: Bachelor's Degree in a science-related field.
• Preferred: Master's Degree; minimum of 3 years’ experience in material review and approval process of pharmaceutical/biologics promotion.
• Ability to understand ABPI, EFPIA and other international codes and guidance on 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.
• Clear and concise communication skills, both written and verbal.
• Ability to manage, motivate, and drive decisions within teams; negotiation and diplomatic skills.
• Cross-functional people management experience and ability to foster a positive team culture.
• Ability to work independently, take initiative, and meet deadlines.
• Previous experience in an advertising and promotion role.

Skills

• Regulatory affairs expertise in advertising and promotion (GRA A&P)
• Project leadership and global process management (CMRP/MMRP)
• Stakeholder management and negotiation
• Regulatory knowledge of FDA codes and international promotion guidelines
• Strategic thinking and business partnering

Education

• Bachelor's Degree in a science-related field (required)
• Master's Degree (preferred)

Additional Requirements

• Remote/hybrid work arrangement as per company policy