Job Posting

Manager, Global Regulatory Affairs, Marketed Products

Boston, Massachusetts

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Job Level: Senior
Travel: Minimal (if any)

Takeda has been translating science into breakthrough medicines for 240 years. Every step of the way, our teams have worked together to tackle some of the most challenging problems in drug discovery and development. Today, we’re a driving force behind innovative therapies that make a lasting difference to millions of patients around the world.

In R&D, all of our history and potential comes together in an environment that welcomes diversity of thought and amplifies every voice. Working closely with colleagues, you’ll play a key role in bringing our rich pipeline of products forward to help patients. Come join a team that’s earned trust for more than two centuries, and find out how advancing transformative therapies at Takeda will shape your bright future.

Job ID R0144985 Date posted 02/21/2025 Location Boston, Massachusetts

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Job Description

Pursuant to Section 20 C.F.R. 656.10, you are hereby notified that an application for Alien Employment Certification will be filed by Takeda Development Center Ameriacs, Inc. for the following job opportunity:

JOB LOCATION: Cambridge, MA

POSITION: Manager, Global Regulatory Affairs, Marketed Products

POSITION DESCRIPTION: Takeda Development Center Americas, Inc. is seeking a Manager, Global Regulatory Affairs, Marketed Products with the following duties: Assist the Global Regulatory Lead (GRL) and is accountable for working with regulatory regional leads, other functions and vendors to ensure global regulatory submissions are provided to local Takeda affiliates in compliance with local regulations and to maintain compliance for products; In collaboration with GRL lead less complex multi-function submissions or support GRLs for more complex submissions; Provide strategic and tactical guidance to teams, including regulatory review of clinical trial documents and collaborates cross functionally to ensure the global regulatory strategy is updated and executed, ensuring global regulatory compliance; Assist the Global Regulatory Lead with Health Authority meetings and responses; Partner with functions responsible for ensuring market access and regional GRA leads to understand market access topics and strategize; opportunities to strengthen product development plan(s) and build into global integrated regulatory strategy. Up to 75% remote work is allowed. Up to 30% domestic travel required

REQUIREMENTS: Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biology or related field and 4 years of prior experience. Prior experience must include: Regulatory submissions to US FDA, EU, and other international health authorities: Manage the authoring, review cycles, finalization, and submission of a Fast Track Designation Request to the US FDA and Orphan Drug Designation request to the EMA; Oversee and manage all Regulatory activities related to ongoing clinical trials and ensure compliance with applicable regulations; Author and manage review cycles for nonclinical regulatory content in submissions like Initial IBs and subsequent updates, briefing books, DSURs, Annual Reports, CTN, IND, CTA, PSP, PIP, 15-day safety notifications, and rapid response document; Submission planning and management of Regulatory submissions: Collaborate with cross-functional team members like Clinical Science, Safety, DSRE, DMPK, Clinical and nonclinical Pharmacology, Regulatory Operations, Publishing, and external teams as needed to ensure timely submissions to Health Authorities; Initiate reviews of regulatory documents, ensure cross-functional team engagement, and conduct comment resolution meetings for timely resolution of comments; Regulatory Intelligence: Perform regulatory analysis, competitor product research, and Probability of Regulatory Success (PRS) exercise for assigned products; Regulatory EDMS and business development support: Provide end-user support for Regulatory electronic document management system (EDMS); Create job aids to simply existing processes and improve adoption of those processes; Represent Regulatory team on business development activities as needed.

Full time. $180,000.00 -$ 246,000.00 per year. Competitive compensation and benefits.

Qualified applicants can apply at https://jobs.takeda.com. Please reference job #R0144985. EOE

Any individual may provide documentary evidence bearing on this application, with information on available workers and information on wages and working conditions, to the Certifying Officer, U.S. Department of Labor, Employment and Training Administration, Office of Foreign Labor Certification, 200 Constitution Avenue, NW, Room N-5311, Washington, DC 20210.

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

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During my 20-year journey here, I’ve been fully supported by my colleagues, and I can’t say enough about our rich internal talent and the long-standing values that drive our decisions as we work to develop important medicines for the patients we serve.

Doug Coffman - Head, R&D Asset Transition & Integration Office, R&D Regional & Business Operations

When making any type of decision, the first thing we ask is 'how will this impact patients?’ Ultimately, we’re laser focused on the best interests of the patient, and I truly believe we follow through on that.

Meredith Culp - VP, Head of Neuroscience Therapeutic Area Strategy & Operations and Head of Global Development Integration Office

Alison Handley, Head, Center for External Innovation

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