Associate Director, Global Regulatory Affairs, Advertising and Promotion

Associate Director, Global Regulatory Affairs, Advertising and Promotion Job Description

At Takeda, we are a forward‑looking, world‑class R&D organization that unlocks innovation and delivers transformative therapies to patients worldwide.

The 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.

• Act as the Subject Matter Expert for assigned products and projects focusing on advertising and promotion regulatory affairs.
• Serve as the Regulatory Advisor and 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.
• Chair CMRP Meetings – communicate comments to coordinator, diffuse team disputes, serve as dependable negotiator, keep team focused on stakeholders, and oversee escalation when needed.
• Act as a strategic business partner from clinical trial development through the marketing maintenance phase of a product lifecycle.
• Serve as subject matter expert on EFPIA, IFPMA, and FDA code/regs, guidance, industry standards, complaints/violations, and innovative promotional platforms.
• Exercise decision‑making authority within the CMRP to ensure compliance, patient safety, and alignment with Takeda’s values.

• BSc Degree, preferred. BA accepted.
• 8+ years in the pharmaceutical industry, including at least 6 years of regulatory experience or 5+ years of regulatory and/or related experience.
• Understanding of 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.
• Proven experience and expertise in regulatory affairs, particularly advertising and promotion, with familiarity in EFPIA, IFPMA, and FDA standards.
• Strong leadership, negotiation, and conflict resolution skills within cross‑functional teams.
• Strategic mindset and ability to assess and advise regulatory impacts across the product lifecycle.
• Adept in guiding teams through complex advertising and promotion processes with a focus on patient safety and compliance.

• Leadership skills: lead and motivate team members; develop, use, and share knowledge and strong interpersonal skills to guide others toward Takeda's goals.
• Strategic approach: identify, create and implement processes for the review of Promotional and Disease awareness materials.
• Change management: identify, advocate and implement change positively for the organization; demonstrate flexibility.
• Analytical and problem‑solving skills: excellent ability to understand complex issues and propose achievable solutions.
• Communication skills: express oneself clearly and concisely.
• Interpersonal flexibility: adapt to other personalities in a…