Takeda Pharmaceutical
Associate Director, Global Regulatory Affairs, Advertising and Promotion
Takeda Pharmaceutical, Cambridge
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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.
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
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 Takedas values.
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.
~ 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.
~ 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.
Strategic Approach ability to identify, create and implement processes for the review of Promotional and Disease awareness materials.
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. 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.
#LI-Remote
#Full time
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.
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
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 Takedas values.
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.
~ 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.
~ 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.
Strategic Approach ability to identify, create and implement processes for the review of Promotional and Disease awareness materials.
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. 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.
#LI-Remote
#Full time