Senior Manager, GRA Marketed Products
Takeda
August 15, 2026
Remote friendly (Boston, MA)
United States
$137,000 - $215,270 USD yearly
Corporate Functions
Job Location: Cambridge, MA
Position: Senior Manager, GRA Marketed Products
Responsibilities:
- Lead the Global Regulatory Team (GRT) and applicable sub-working groups (e.g., Label Working Group) and represent GRT at project team meetings.
- Define regulatory strategies and provide tactical guidance; collaborate cross-functionally to update and execute global regulatory strategy to ensure compliance.
- Communicate regulatory-relevant developments to project teams, line management, and stakeholders.
- Develop solutions to identified risks; evaluate probabilities of technical success.
- Be accountable for all US FDA submissions and approvals for assigned projects.
- Serve as direct point of contact with FDA; lead and manage FDA meetings.
- Work with regulatory regional leads, other functions, and vendors to provide global regulatory submissions to local affiliates in compliance with local regulations.
- Oversee vendor regulatory responsibilities and submissions within project scope.
- Lead regulatory review in due diligence for licensing opportunities.
- Partner with global market access on interactions with regulatory/health agency/HTA bodies for product-specific value evidence topics.
- Monitor and anticipate regulatory/access trends to strengthen product development plans and adopt timely regulatory strategies.
- Up to 80% remote work allowed.
Requirements:
- Bachelor’s degree in Pharmacy or related field.
- 6+ years’ experience in the healthcare regulatory industry, including applying FDA, EU, and Health Canada regulations to design and execute regulatory strategies for global compliance.
- Experience planning/managing global regulatory submissions for lifecycle management; leading development/execution of regulatory strategies and leading/negotiating with health authorities.
- Experience managing authoring, review cycles, finalization, and submission of US/EU regulatory submissions.
Full-time. $137,000–$215,270 per year.
Benefits (if applicable): short- and/or long-term incentives; medical/dental/vision; 401(k) with company match; disability coverage; life insurance; tuition reimbursement; paid volunteer time off; company holidays; well-being benefits; up to 80 hours sick time/year; up to 120 hours paid vacation for new hires.
Application: Apply at https://jobs.takeda.com and reference job # R0186794.
Position: Senior Manager, GRA Marketed Products
Responsibilities:
- Lead the Global Regulatory Team (GRT) and applicable sub-working groups (e.g., Label Working Group) and represent GRT at project team meetings.
- Define regulatory strategies and provide tactical guidance; collaborate cross-functionally to update and execute global regulatory strategy to ensure compliance.
- Communicate regulatory-relevant developments to project teams, line management, and stakeholders.
- Develop solutions to identified risks; evaluate probabilities of technical success.
- Be accountable for all US FDA submissions and approvals for assigned projects.
- Serve as direct point of contact with FDA; lead and manage FDA meetings.
- Work with regulatory regional leads, other functions, and vendors to provide global regulatory submissions to local affiliates in compliance with local regulations.
- Oversee vendor regulatory responsibilities and submissions within project scope.
- Lead regulatory review in due diligence for licensing opportunities.
- Partner with global market access on interactions with regulatory/health agency/HTA bodies for product-specific value evidence topics.
- Monitor and anticipate regulatory/access trends to strengthen product development plans and adopt timely regulatory strategies.
- Up to 80% remote work allowed.
Requirements:
- Bachelor’s degree in Pharmacy or related field.
- 6+ years’ experience in the healthcare regulatory industry, including applying FDA, EU, and Health Canada regulations to design and execute regulatory strategies for global compliance.
- Experience planning/managing global regulatory submissions for lifecycle management; leading development/execution of regulatory strategies and leading/negotiating with health authorities.
- Experience managing authoring, review cycles, finalization, and submission of US/EU regulatory submissions.
Full-time. $137,000–$215,270 per year.
Benefits (if applicable): short- and/or long-term incentives; medical/dental/vision; 401(k) with company match; disability coverage; life insurance; tuition reimbursement; paid volunteer time off; company holidays; well-being benefits; up to 80 hours sick time/year; up to 120 hours paid vacation for new hires.
Application: Apply at https://jobs.takeda.com and reference job # R0186794.