Takeda
Associate Director, Global Regulatory Affairs-Advertising and Promotion Review L
Takeda, Boston, MA, US, 02298
Associate Director, Global Regulatory Affairs-Advertising and Promotion Review Lead
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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 will support our growing Oncology Portfolio. You will be accountable for management of all assigned programs/products as the internal expert on US codes, guidance, and industry standards pertaining to prescription medicine promotion.
How you will contribute
Serve as GRA A&P SME for assigned products and projects.
Regulatory advisor as the “R” in the core Medical, Legal, Regulatory review functions of the Commercial Material Review Process (CMRP) and Medical Material Review Process (MMRP) for both Commercial and Medical material development, review, approval, and implementation.
Product or project business lead for global CMRP at Takeda.
CMRP Meeting Chair—pause to communicate comments to coordinator, diffuse team disputes, serving as a dependable negotiator, keeping team focus on our ultimate stakeholders, the patients.
Strategic business partner from clinical trial development through the marketing maintenance phase of a product lifecycle.
Subject matter expert on FDA code/regs, guidance, industry standards, complaints/violations, and innovative promotional platforms, with additional training on International Codes (e.g., EFPIA, IFPMA) and guidelines for global product support.
Partner closely with line‑management, Oncology GRA A&P Portfolio Lead and inform or bring in Head of GRA A&P for complex review concepts or topics.
Empowered decision‑maker within the CMRP.
Minimum Requirements / Qualifications
Bachelor’s Degree in a science‑related field is required.
Master’s Degree preferred. Minimum of 3 years’ experience required in material review and approval process of pharmaceutical/biologics promotion.
Ability to 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.
More about us
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best‑in‑class patient support programmes. Takeda is a patient‑focused company that will inspire and empower you to grow through life‑changing work. We are a Global Top Employer, encouraging innovation and striving for excellence in everything we do. We foster an inclusive, collaborative workplace, 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.
Location & Compensation
Location: Massachusetts – Virtual
U.S. Base Salary Range: The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including qualifications, experience, skills, education, certifications, and location. U.S. based employees may be eligible for short‑term and/or long‑term incentives, medical, dental, vision insurance, 401(k) plan with company match, short‑term and long‑term disability coverage, basic life insurance, tuition reimbursement, paid volunteer time off, company holidays, well‑being benefits, up to 80 hours of sick time, and accrual of up to 120 hours of paid vacation.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
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