Takeda · 1 day ago
Associate Director, Global Regulatory Affairs, Advertising and Promotion
Cambridge, MA
Full-time
Onsite
Lead/Staff, Director/Executive
$154K/yr - $241K/yr
8+ years expTakeda is a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. The Associate Director, Global Regulatory Affairs Advertising and Promotion is responsible for managing assigned programs/products and providing regulatory guidance during the development and review of medical and commercial materials, ensuring compliance with industry standards and regulations.
BiotechnologyHealth CareManufacturingMedicalPharmaceutical
Responsibilities
Act as the Subject Matter Expert for assigned products and projects focusing on advertising and promotion regulatory affairs
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
Serve as product or project business lead for global CMRP at Takeda
Chair CMRP Meetings, communicate comments to coordinator, diffuse team disputes, serve as a dependable negotiator, keep team focus on stakeholders, and oversee escalation steps if MLR cannot come to alignment or if there is new data or campaigns requiring senior level management input or alignment
Act as a strategic business partner from clinical trial development through the marketing maintenance phase of a product lifecycle
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
Qualification
Required
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
Company
Takeda
Takeda is a biopharmaceutical company that researches and develops pharmaceutical drugs.
10001+ employees
H1B Sponsorship
Takeda has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (45)
2024 (39)
2023 (38)
2022 (34)
2021 (44)
2020 (18)
Funding
Current Stage
Public CompanyTotal Funding
$2.46B2025-06-27Post Ipo Debt· $2.4B
2016-09-01Grant· $19.8M
2016-05-08Grant· $38M
Leadership Team
Christophe Weber
President and CEO
Schuyler Fairfield
Senior Vice President, Global Head of Supply Chain
Recent News
2026-01-25
legacy.thefly.com
2026-01-23
2026-01-22
Company data provided by crunchbase