Senior Manager, Regulatory Affairs - Advertising Compliance

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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 Takedas values.

Minimum Requirements / Qualifications :

Additional Skills :

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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Locations

CHE - Glattpark (Opfikon) - Zurich HQUSA - MA - Cambridge

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time