Associate Director, Global Regulatory Affairs, Advertising and Promotion

Role Summary

Associate Director, Global Regulatory Affairs Advertising and Promotion (GRA A&P) Review Lead is accountable for management of all assigned programs/products as the internal expert on US and international Codes, guidance, and industry standards pertaining to prescription medicine promotion.

Responsibilities

• Act as the Subject Matter Expert for assigned products and projects focusing on advertising and promotion regulatory affairs.
• Function as the “R” in the core Medical, Legal, and Regulatory review functions within the Commercial Material Review Process (CMRP). Provide regulatory guidance during development, review, approval, and implementation of medical and commercial materials.
• Be the product or project business lead for global CMRP at Takeda.
• CMRP Meeting Chair—communicate comments to coordinator, diffusing team disputes, negotiator, and oversee escalation steps if alignment is not reached or if 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 subject matter expert on EFPIA, IFPMA, and FDA code/regs, guidance, industry standards, complaints/violations, and innovative promotional platforms.
• Act as strategic partner spanning clinical trial development through marketing and maintenance phases of the product lifecycle.
• Provide regulatory expertise on EFPIA, IFPMA, and FDA codes, regulations, guidance, industry standards, and innovative promotional platforms.
• Exercise decision-making authority within the CMRP to ensure compliance, patient safety, and alignment with Takeda’s values.

Qualifications

• BSc Degree, preferred. BA accepted.
• 8+ years of pharmaceutical industry experience, including 6 years of regulatory experience or 5+ years regulatory and/or related experience.
• Understanding of ABPI, EFPIA and other international advertising and promotion codes and guidance for prescription medicines.
• Experience in prescription medicine promotion development and review processes.
• Strong interpersonal skills with ability to demonstrate strategic and analytic thinking.
• Excellent written and verbal communication skills to manage, motivate and drive decisions within teams.
• Proven negotiation, influencing without authority, and conflict-diplomacy skills.
• Demonstrated cross-functional people management with a positive team culture.
• Ability to work independently, take initiative and meet deadlines.
• Previous experience in an advertising and promotion role.
• Proven expertise in regulatory affairs, particularly advertising and promotion, with familiarity in EFPIA, IFPMA, and FDA standards.
• Leadership, negotiation, and conflict resolution skills within cross-functional teams.
• Strategic mindset and ability to assess regulatory impacts across the product lifecycle.

Skills

• Leadership—lead and motivate team members, guide others toward Takeda's goals.
• Strategic Approach—to identify, create and implement review processes for Promotional and Disease awareness materials.
• Change Management—advocate and implement positive organizational change; flexibility.
• Analytical and Problem-Solving Skills—understand complex issues and propose solutions.
• Communication Skills—clear and concise expression.
• Interpersonal Flexibility—adapt to different personalities respectfully to achieve goals.
• Teamwork—effective in a highly cross-functional environment.
• Presentation Skills—create and deliver targeted presentations.

Education

• BSc preferred; BA accepted.

Additional Requirements

• Remote work eligibility and location considerations as per company policy.