Director, Global Regulatory Affairs, Neuroscience
Takeda
August 16, 2026
Remote friendly (Boston, MA)
United States
$177,000 - $278,080 USD yearly
Corporate Functions
Responsibilities:
- Develop innovative global regulatory strategies and provide strategic regulatory guidance for Neuroscience TAU portfolio products.
- Lead product-specific Global Regulatory Teams (GRTs) and represent Regulatory on cross-functional Global Program Teams.
- Define, develop, and lead global regulatory strategies to maximize success for complex/multiple projects.
- Stay current on regulatory science and monitor evolving regulatory landscape.
- Interpret scientific data to guide regulatory strategy.
- Lead and manage increasingly complex/multiple projects; oversee GRT and sub-working groups; update and execute global regulatory strategy for compliance.
- Keep stakeholders apprised of developments impacting regulatory success.
- Anticipate risks and develop risk solutions/mitigations; assess technical success probabilities.
- Accountable for US FDA submissions and approvals (or oversee direct reports/junior staff); lead highly complex submission types (e.g., original NDA/BLAs).
- Serve as primary FDA contact; lead/manage FDA meetings.
- Ensure global submissions provided to local affiliates in compliance with local regulations; maintain product compliance.
- Oversee vendor regulatory activities/submissions within scope.
- Lead regulatory reviewer for licensing due diligence.
- Partner with global market access on regulatory/agency/HTA value evidence topics.
- Monitor regulatory and access trends to strengthen product development plans and timely regulatory strategy.
Minimum/Preferred Qualifications:
- BSc (preferred); BA accepted.
- 10+ years pharmaceutical industry experience, incl. 6 years regulatory (or 5+ years regulatory/related experience).
- Preferred: experience reviewing/authoring/managing regulatory submission components.
- Solid knowledge of drug development and regulatory requirements; FDA/EU/Canada/ROW and post-marketing a plus.
- Strong communications; timeline management; negotiation; integrity; adaptability.
- Ability to work in global teams and independently develop regulatory strategies; proactively identify regulatory issues and propose creative, risk-mitigating solutions.
Benefits:
- Not specified (exclude company benefit/compensation sections).
Application instructions:
- By clicking “Apply,” you begin Takeda’s employment application process and agree to Privacy Notice/Terms of Use; attest provided information is true.
- Develop innovative global regulatory strategies and provide strategic regulatory guidance for Neuroscience TAU portfolio products.
- Lead product-specific Global Regulatory Teams (GRTs) and represent Regulatory on cross-functional Global Program Teams.
- Define, develop, and lead global regulatory strategies to maximize success for complex/multiple projects.
- Stay current on regulatory science and monitor evolving regulatory landscape.
- Interpret scientific data to guide regulatory strategy.
- Lead and manage increasingly complex/multiple projects; oversee GRT and sub-working groups; update and execute global regulatory strategy for compliance.
- Keep stakeholders apprised of developments impacting regulatory success.
- Anticipate risks and develop risk solutions/mitigations; assess technical success probabilities.
- Accountable for US FDA submissions and approvals (or oversee direct reports/junior staff); lead highly complex submission types (e.g., original NDA/BLAs).
- Serve as primary FDA contact; lead/manage FDA meetings.
- Ensure global submissions provided to local affiliates in compliance with local regulations; maintain product compliance.
- Oversee vendor regulatory activities/submissions within scope.
- Lead regulatory reviewer for licensing due diligence.
- Partner with global market access on regulatory/agency/HTA value evidence topics.
- Monitor regulatory and access trends to strengthen product development plans and timely regulatory strategy.
Minimum/Preferred Qualifications:
- BSc (preferred); BA accepted.
- 10+ years pharmaceutical industry experience, incl. 6 years regulatory (or 5+ years regulatory/related experience).
- Preferred: experience reviewing/authoring/managing regulatory submission components.
- Solid knowledge of drug development and regulatory requirements; FDA/EU/Canada/ROW and post-marketing a plus.
- Strong communications; timeline management; negotiation; integrity; adaptability.
- Ability to work in global teams and independently develop regulatory strategies; proactively identify regulatory issues and propose creative, risk-mitigating solutions.
Benefits:
- Not specified (exclude company benefit/compensation sections).
Application instructions:
- By clicking “Apply,” you begin Takeda’s employment application process and agree to Privacy Notice/Terms of Use; attest provided information is true.