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Job Description

About the role:

At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing 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.

How you will contribute:

• 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.

Minimum Requirements/Qualifications:

• BSc Degree, preferred. BA accepted. 

• 8+ years of pharmaceutical industry experience. This is inclusive of 6 years of regulatory experience or combination of 5+ years regulatory and/or related experience. 

• You can understand 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.

Additional Skills:

• Leadership Skills can lead and motivate team members. Develops, uses and shares knowledge and uses strong interpersonal skills to guide others (both inside and outside the department) toward the accomplishment of Takeda's goals and objectives.

• Strategic Approach – ability to identify, create and implement processes for the review of Promotional and Disease awareness materials.

• Change Management — ability to identify, advocate and implement change positively for the organizations Demonstrates flexibility and the ability to accommodate change.

• Analytical and Problem-Solving Skills - Excellent ability to understand complex issues and propose achievable solutions.

• Communication Skills ability to express oneself clearly and concisely.

• Interpersonal Flexibility - ability to adapt to other personalities in a respectful manner that is conducive to goal achievement.

• Teamwork - the ability to work well in a highly cross-functional team environment.

• Presentation skills — create and deliver presentations with appropriate messaging and focused recommendations.

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

This position is currently classified as "remote" following Takeda's Hybrid and Remote Work policy.

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