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

Role Summary

Associate Director, Global Regulatory Affairs Advertising and Promotion (GRA A&P) Review Lead will support the Oncology Portfolio and serve as the internal expert on US Codes, guidance, and industry standards pertaining to prescription medicine promotion. This role involves management of assigned programs/products and leadership within the Commercial and Medical Material Review Processes (CMRP/MMRP).

Responsibilities

• Serve as GRA A&P SME for assigned products and projects.
• Regulatory advisor in the core Medical, Legal, Regulatory review functions of the CMRP and MMRP for both Commercial and Medical material development, review, approval, and implementation.
• Act as product or project business lead for global CMRP at Takeda.
• Chair CMRP meetings, communicate comments, resolve disputes, negotiate, maintain focus on patients, and oversee escalation steps when alignment is not reached or new data/campaigns require senior input.
• Serve as strategic business partner from clinical trial development through the marketing maintenance phase of a product lifecycle.
• Be the subject matter expert on FDA codes/regulations, guidance, industry standards, complaints/violations, and innovative promotional platforms; gain training on international codes (EFPIA, IFPMA) for global product support.
• Collaborate with line-management and inform or involve the Head of GRA A&P for complex concepts or topics.
• Act as an 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 of pharmaceutical/biologics promotion.
• Ability to understand ABPI, EFPIA and other international codes and guidance for prescription medicines.
• Experience in prescription medicine promotion development and review process.
• Strong interpersonal, strategic, and analytical thinking skills.
• Clear and concise communication skills; effective written and verbal ability to manage and drive decisions within teams.
• Negotiation, influencing without authority, and diplomatic conflict resolution abilities.
• Cross-functional people management with a commitment to 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 of prescription medicines
• Knowledge of US and international advertising codes and guidelines
• Project leadership and stakeholder management
• Strong negotiation and communication skills
• Cross-functional collaboration and team leadership

Education

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