Associate Director, Global Regulatory Affairs, Advertising and Promotion

Role Summary

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.

Responsibilities

• As our Associate Director, Global Regulatory Affairs Advertising and Promotion lead you will act as the Subject Matter Expert for assigned products and projects focusing on advertising and promotion regulatory affairs.
• You will be the Regulatory Advisor and 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.
• You will be product or project business lead for global CMRP at Takeda
• CMRP Meeting Chair - pausing to communicate comments to coordinator, diffusing team disputes, serving as a dependable negotiator, keeping team focus on our ultimate stakeholders which are the patients who trust us to do the right thing, and overseeing escalation steps if MLR cannot come to alignment or if there is new data or campaigns that require senior level management input or alignment.
• Strategic business partner from clinical trial development through the marketing maintenance phase of a product lifecycle
• Subject matter expert on EFPIA, IFPMA, and FDA code/regs, guidance, industry standards, complaints/violations, and innovative promotional platforms
• Act as a strategic partner spanning clinical trial development through the marketing and maintenance phases of the product lifecycle.
• Regulatory Subject Matter Expert Provide 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

• Required: BSc Degree (BA accepted)
• Required: 8+ years of pharmaceutical industry experience, including 6 years of regulatory experience or a combination of 5+ years regulatory and/or related experience
• Required: Understanding of ABPI, EFPIA and other international codes and guidance about advertising and promotion for prescription medicines
• Required: Experience in prescription medicine promotion development and review process
• Required: Strong interpersonal skills with ability to demonstrate strategic and analytic thinking
• Required: Clear and concise communication; highly effective written and verbal skills to manage, motivate and drive decisions within teams
• Required: Negotiation, influencing without authority, and diplomatic conflict resolution skills
• Required: Cross-functional people management and ability to foster a positive team culture
• Required: Ability to work independently, take initiative and meet deadlines
• Required: Prior experience in an advertising and promotion role
• Required: Regulatory affairs expertise in advertising and promotion, with familiarity in EFPIA, IFPMA, and FDA standards
• Required: Leadership, negotiation, and conflict resolution skills within cross-functional teams
• Required: Strategic mindset to assess regulatory impacts across the product lifecycle
• Required: Ability to guide teams through complex advertising and promotion processes with a focus on patient safety and compliance

Education

• BSc Degree preferred; BA accepted

Skills

• Leadership – ability to lead and motivate team members; guide others toward Takeda's goals
• Strategic Approach – develop and implement review processes for Promotional and Disease awareness materials
• Change Management – manage organizational change with flexibility
• Analytical and Problem-Solving – understand complex issues and propose solutions
• Communication – clear and concise messaging
• Interpersonal Flexibility – adapt to different personalities respectfully
• Teamwork – collaborate effectively in a cross-functional environment
• Presentation – create and deliver focused presentations