Senior Manager, Global Regulatory Affairs, Marketed Products

USA - 3316 Takeda Development Center Americas, Inc.; Cambridge (MA); Remote; USD 201,000 - 215,000; Full time

Job summary

Takeda is seeking a Senior Manager, Global Regulatory Affairs, Marketed Products in Cambridge, MA to oversee regulation submissions and strategic regulatory activities for global marketed products. You will collaborate with GRL and regional leads to align with local requirements while driving efficient submissions.

Responsibilities include leading cross-functional teams, guiding health authority interactions, and shaping the global regulatory strategy with a focus on market access and

Qualifications

• Bachelor’s degree in Pharmacy, Pharmaceutical Science, Chemistry, Biology, or related field, plus 4 years of related experience.
• Experience with US FDA, EU and other health authorities regulatory submissions.
• Experience managing regulatory activities for ongoing clinical trials.
• Ability to author and manage review cycles for regulatory content.
• Experience planning and managing regulatory submissions.
• Regulatory intelligence and PRS analysis.
• Proficiency with Regulatory EDMS.

Responsibilities

• Assist the Global Regulatory Lead (GRL) and coordinate with regulatory regional leads to ensure global regulatory submissions are provided to local affiliates in compliance with regulations.
• 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 collaborate cross-functionally to ensure the global regulatory strategy is updated and executed.
• Assist the Global Regulatory Lead with Health Authority meetings and responses.
• Partner with functions responsible for market access and regional GRA leads to understand market access topics and strategize.
• Opportunities to strengthen product development plans and build into global integrated regulatory strategy.

Skills

Regulatory submissions

Strategic guidance

Cross-functional leadership

Regulatory intelligence

Education

Bachelor's degree in Pharmacy, Pharmaceutical Science, Chemistry, Biology, or related field

Tools

Regulatory EDMS

FDA/EMA knowledge

Job description

JOB LOCATION

Cambridge, MA

POSITION

Senior Manager, Global Regulatory Affairs, Marketed Products

POSITION DESCRIPTION

• 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.

• 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

$200,678 to $215,270 per year.

Full time.

Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time

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

Please reference job #R0189747.

Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism – Integrity, Fairness, Honesty, and Perseverance – and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own.