Senior Manager, Regulatory Lead
Takeda
June 25, 2026
Remote friendly (Boston, MA)
United States
$137,000 - $215,270 USD yearly
Corporate Functions
About The Role
The Plasma-Derived Therapies (PDT) R&D Organization brings forward new plasma-derived therapies. As Manager Regulatory Lead, you will recommend and implement regulatory strategy and coordinate life cycle activities across the PDT portfolio.
How you will contribute
- Serve as regulatory lead for one or more projects; coordinate Global Regulatory Team (GRT) meetings.
- Provide strategic/tactical advice to ensure timely, efficient development and maintenance while meeting regulatory requirements.
- Liaise with the US FDA on submissions within responsibilities.
- Lead interface between global regulatory affairs, subject matter experts, and regional teams (LOCs; EU/Canada strategy; Japan/China) to collect regulatory documentation for registrations and license maintenance.
- Create and execute global regulatory strategies for assigned programs; keep strategies up to date.
- Support and execute global regulatory submissions; author/submit compliant regulatory documents (e.g., BLAs, INDs, CTAs, MAAs, Variations/Supplements, PIPs/PSPs, ODDs, meeting requests, briefing packages) within timelines.
- Manage risk/resource gaps; anticipate risks and develop solutions.
- Ensure accurate program status reporting via InterACT and regulatory dashboard; use Dragonfly to flag discrepancies.
- Collaborate with LOCs to identify submission documents, responsible SMEs, and facility deliverables/timelines.
Minimum Requirements/Qualifications
- BSc preferred; advanced degree a plus (BA accepted).
- 4+ years in pharmaceutical industry; 2+ years in regulatory strategy.
- Plasma/biologics experience preferred.
- Experience reviewing/authoring/managing regulatory submissions preferred.
- Knowledge of global regulatory requirements; prior FDA interactions/submissions.
- Strong communication; timeline management; negotiation skills; integrity and adaptability.
- Ability to work in a matrixed environment.
The Plasma-Derived Therapies (PDT) R&D Organization brings forward new plasma-derived therapies. As Manager Regulatory Lead, you will recommend and implement regulatory strategy and coordinate life cycle activities across the PDT portfolio.
How you will contribute
- Serve as regulatory lead for one or more projects; coordinate Global Regulatory Team (GRT) meetings.
- Provide strategic/tactical advice to ensure timely, efficient development and maintenance while meeting regulatory requirements.
- Liaise with the US FDA on submissions within responsibilities.
- Lead interface between global regulatory affairs, subject matter experts, and regional teams (LOCs; EU/Canada strategy; Japan/China) to collect regulatory documentation for registrations and license maintenance.
- Create and execute global regulatory strategies for assigned programs; keep strategies up to date.
- Support and execute global regulatory submissions; author/submit compliant regulatory documents (e.g., BLAs, INDs, CTAs, MAAs, Variations/Supplements, PIPs/PSPs, ODDs, meeting requests, briefing packages) within timelines.
- Manage risk/resource gaps; anticipate risks and develop solutions.
- Ensure accurate program status reporting via InterACT and regulatory dashboard; use Dragonfly to flag discrepancies.
- Collaborate with LOCs to identify submission documents, responsible SMEs, and facility deliverables/timelines.
Minimum Requirements/Qualifications
- BSc preferred; advanced degree a plus (BA accepted).
- 4+ years in pharmaceutical industry; 2+ years in regulatory strategy.
- Plasma/biologics experience preferred.
- Experience reviewing/authoring/managing regulatory submissions preferred.
- Knowledge of global regulatory requirements; prior FDA interactions/submissions.
- Strong communication; timeline management; negotiation skills; integrity and adaptability.
- Ability to work in a matrixed environment.