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Job DescriptionPursuant 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 Americas, Inc. for the following job opportunity:
JOB LOCATION: Cambridge, MA
POSITION: Senior Manager, Global Regulatory Affairs, Marketed Products
POSITION DESCRIPTION: Takeda Development Center Americas, Inc. is seeking a Senior 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 company 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 for business meetings and discussion.
Estimated salary range reflects expected pay for this role. Actual base salary depends on the applicant’s qualifications, experience, skills, education, certifications, & work location, & will comply with all applicable minimum‑wage laws. U.S. employees may be eligible for medical, dental, & vision insurance, 401(k), paid time off, sick leave, company holidays, incentive compensation programs, & other benefits offered under company policies.
REQUIREMENTS: Bachelor’s degree in Pharmacy, Pharmaceutical Science, Chemistry, Biology, or related field, plus 4 years of related 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. $200,678 to $215,270 per year.
Qualified applicants can apply at https://jobs.takeda.com. Please reference job #R0189747. 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
LocationsBoston, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull timeSkills Required
- Bachelor's degree in Pharmacy, Pharmaceutical Science, Chemistry, Biology, or a related field.
- At least 4 years of related regulatory affairs experience.
- Experience preparing and managing regulatory submissions to the US FDA, EU, and other international health authorities, including Fast Track and Orphan Drug designation requests.
- Experience managing regulatory activities for clinical trials and ensuring compliance with applicable regulations.
- Experience authoring and managing review cycles for regulatory documents, including investigator brochures, briefing books, DSURs, annual reports, CTNs, INDs, CTAs, PSPs, PIPs, safety notifications, and rapid response documents.
- Experience coordinating cross-functional regulatory submission planning, document reviews, comment resolution, and Health Authority interactions.
- Experience performing regulatory intelligence, competitor product research, and Probability of Regulatory Success exercises.
- Experience supporting regulatory electronic document management systems, creating job aids, and participating in business development activities.
Takeda Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Takeda and has not been reviewed or approved by Takeda.
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Retirement Support — Employer-funded retirement is described as notably strong, combining a dollar-for-dollar 401(k) match with an additional company contribution that scales with age and service. Access to an employee stock purchase plan further supports long-term wealth building.
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Parental & Family Support — Paid bonding leave for all parents, substantial adoption/surrogacy reimbursement, and robust caregiver resources (backup care and Maven family-forming support) are emphasized as core strengths. These offerings create a comprehensive safety net for a range of family situations.
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Healthcare Strength — Multiple medical plan options (nationwide PPO/HSA and regional HMOs), employer HSA funding, and integrated mental-health and well-being programs signal depth in coverage. Preventive care is covered in-network, and plan choices by state expand access.
Takeda Insights
What We Do
For over 240 years, Takeda’s propensity to evolve has driven the next generation of innovation, and as a future-focused organization, we’re continuing to drive forward with endurance in our steadfast pursuit to achieve the best outcomes for our patients in a rapidly changing world. We have been preparing for this period of value creation by investing in data, digital and technology, and we’re proud of our employees and their commitment to turning groundbreaking ideas into life-changing impacts. Since our founding in Japan, integrity and putting patients first have been at the heart of our identity, and we will emerge ready for our future as one of the most trusted and science-driven digital biopharmaceutical companies. Join a team where your innovation impacts lives. Together, we’ll realize improved outcomes by improving data quality, enhancing launch execution and improving the patient journey. You’ll play a critical role in accelerating data collection and increasing accuracy across all parts of the business. Patients across the globe will benefit from access to treatments afforded by greater opportunities and efficiency in our research and development.
Why Work With Us
We connect to our history and Japanese heritage through everything we do to bring our purpose, values, vision, and imperatives to life. We are committed to bringing better health and a brighter future to patients. Being a part of Takeda means having the opportunity to be a part of something bigger than yourself.
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