Manager, Global Regulatory Affairs, Marketed Products

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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.

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