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Manager, Global Regulatory Affairs, Marketed Products

Boston, Massachusetts

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Job Level: Senior
Travel: Minimal (if any)

Global Regulatory Affairs (GRA) develops and executes innovative regulatory strategies to provide life-changing therapies to patients. GRA has a strategic role in all stages of global product development and across the Takeda Enterprise.

At Takeda, we strive to provide transformational opportunities for every member of our team, and we empower our people to take charge of their futures. In an environment that fosters lifelong learning and a growth mindset, you’ll have the support you need to thrive — at work and beyond.

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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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Where you fit in

When you join our Regulatory Affairs team, you’ll help ensure the fastest, safest path for our treatments to get to patients. With colleagues who encourage you to question everything for better outcomes, you’ll be part of a team that’s deeply involved across each therapeutic area, from candidate selection to post-marketing.

At Takeda, you’ll join an environment with the energy and flexibility of a startup. We continue building on our 240-year history as a global biopharmaceutical leader through our innovative mindset and lean governance. Find everything you need on our Regulatory Affairs team to positively impact patients’ lives while taking strides within your own.

Oversee regulatory activities
Provide strategic focus
Collaborate cross functionally
Ensure regulatory compliance

We sit outside of the traditional disciplines, so we’re able to get involved in everything.Our role is to distill complex information and pull insights that give us a competitive advantage.

Nahid Latif - Head, Global Regulatory Affairs

Integrity is at the center of everything we do. This value is not something that you teach — it comes with the package.

Tatiana Ishida - Head of Global Regulatory Affairs, Marketed Products Development, Labeling and Advertising & Promotion

We sit outside of the traditional disciplines, so we’re able to get involved in everything.Our role is to distill complex information and pull insights that give us a competitive advantage.

Nahid Latif - Head, Global Regulatory Affairs

Integrity is at the center of everything we do. This value is not something that you teach — it comes with the package.

Tatiana Ishida - Head of Global Regulatory Affairs, Marketed Products Development, Labeling and Advertising & Promotion

We sit outside of the traditional disciplines, so we’re able to get involved in everything.Our role is to distill complex information and pull insights that give us a competitive advantage.

Nahid Latif - Head, Global Regulatory Affairs

The heart of our work

Shining a light on new perspectives

Our pipeline

Our internal research capabilities and external partnerships contribute to an R&D engine that has produced exciting new molecular entities (NMEs) across our core Therapeutic Areas. Check out our pipeline and see how we’ll continue delivering a steady stream of next-generation therapies.

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What we believe in

Our values of Takeda-ism are Integrity, Fairness, Honesty and Perseverance, with Integrity as the core. These are brought to life through actions based on Patient, Trust, Reputation and Business, in that order.

Our belief in putting people first extends beyond our patients — it includes their families and communities, as well as our Takeda colleagues and their families.

We are committed to embracing our differences, valuing different perspectives, and fostering a culture of respect, inclusiveness and empowerment.

Our embedded Diversity, Equity & Inclusion (DE&I) strategy enables us to attract and retain exceptional talent, drives innovation, and helps address systemic inequalities in our communities.

Integrity
Fairness
Honesty
Perseverance

Working at Takeda

Inclusion
Here, you will feel welcomed, respected, and valued as a vital contributor to our global team.
Collaboration
A strong, borderless team, we strive together towards our priorities and inspiring mission.
Innovation
Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.
Top Workplace
Recognized for our culture and way of working, we’re one of only 17 companies to receive Top Global Employer® status for 2024.
Work-Life
Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.
Empowerment
Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.