Title: REMOTE Senior Manager, US Ad / Promo Regulatory Review

About the role:

Are you looking for a patient-focused company to inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Senior Manager, US Ad / Promo Regulatory Review. You will report to the Director, Ad/Promo Regulatory Review.

As a Senior Manager, US Ad / Promo Regulatory Review, working on the US Medical team, you will be empowered to serve as an internal expert on FDA regulations, guidance, and enforcement trends governing the promotion of prescription drug and biologic products. You will contribute to Takeda's mission by providing regulatory strategic oversight for complex products or therapeutic area products to help ensure regulatory compliance of promotional materials generated for assigned US products and/or compounds

How you will contribute:

• Serve as a primary regulatory reviewer for promotional materials related to assigned products, ensuring alignment with applicable FDA regulations and Takeda standards.
• Be an internal expert on FDA regulations, guidance, and enforcement trends governing the promotion of prescription drug and biologic products.
• Provide regulatory strategic input for materials and campaigns, to help ensure regulatory compliance of promotional materials generated for assigned US products and/or compounds.
• Under the guidance of leadership, prepare advisory comment submissions and responses to FDA, acting as a liaison in these interactions for assigned products.
• Be the chair of promotional review meetings and assist Commercial with the planning and prioritization of proposed promotional and disease state materials.
• Collaborate cross-functionally with Regulatory Affairs, Medical, Legal, Compliance, and Commercial teams to ensure materials meet regulatory and business objectives. Provide expert guidance to help evaluate and mitigate potential risk.

• Be an internal expert on FDA regulations, guidance, and enforcement trends governing the promotion of prescription drug and biologic products. Thoroughly review and assess proposed promotional items to evaluate their completeness, accuracy, and compliance with regulatory requirements.
• Understand broad concepts within Regulatory Affairs and potential effects across the organization. Identify regulatory issues or risks in review processes, proposing creative solutions, including risk mitigation strategies independently or in collaboration with leadership.

• Monitor FDA regulations, guidance, and enforcement trends, and communicate relevant updates that may impact promotional activities or strategy and present to cross-functional teams regarding shared insights from FDA advisory comments, recent enforcement actions, and/or guidance documents.

• Offer input on product development labeling strategies to ensure promotional claims can be supported.
• Support team development by mentoring junior colleagues and contributing to process improvements within Ad/Promo regulatory frameworks.

What you bring to Takeda:

• Bachelor's Degree in life sciences or equivalent; Advanced degree (PharmD, MS, MBA, JD) preferred.
• Minimum of 4 years' experience in Regulatory Affairs or related fields, including 2+ years of Advertising and Promotion regulatory review experience preferred.
• Strong knowledge of FDA regulations and guidance specific to the promotion of prescription drug and biologic products for healthcare professionals, payors, and consumers.
• Demonstrated ability to provide strategic input and manage review processes while collaborating across teams.
• Proficiency in navigating complex regulatory issues and initiatives with a solution-oriented approach.
• Strong leadership potential, organizational skills, and the ability to mentor junior team members.

Licenses/Certifications:

• Regulatory Affairs Certification (RAC) is desirable but not mandatory.

Travel Requirements:

• Willingness to travel to meetings or client sites, including overnight trips. Some international travel may be required.
• Requires approximately up to 25% travel.

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location:
Massachusetts - Virtual

U.S. Base Salary Range:
$137,000.00 - $215,270.00

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

For information about our benefits, please click here.

Locations
Massachusetts - Virtual

Worker Type
Employee

Worker Sub-Type
Regular

Time Type
Full time

Job Exempt
Yes

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.