Franchise Lead (Director, Global Regulatory Affairs CMC)
Takeda
August 08, 2026
Remote friendly (Boston, MA)
United States
$177,000 - $278,080 USD yearly
Corporate Functions
Responsibilities:
- Serve as the GRA CMC Franchise Lead for TAK-079.
- Independently develop regulatory CMC strategy and lead execution of investigational, registration, and post-approval regulatory CMC strategies as GRA CMC Product Lead.
- Represent Regulatory/Pharmaceutical Development/Commercial project teams through clinical development and commercial lifecycle.
- Lead preparation of major global registrational submissions; guide strategy for CMC dossier content and ensure conformance with requirements.
- Represent Takeda GRA CMC in Health Authority meetings; drive CMC meeting preparation.
- Provide guidance on administrative/procedural topics with International Health Authorities.
- Provide strategic input into change control evaluation; ensure/enhance regulatory compliance.
- Review and provide regulatory CMC input/approval for technical protocols, reports, and related documents.
- Prepare and maintain regulatory documentation (e.g., technical regulatory strategy documents, storyboards, risk assessments); provide tactical guidance.
- Accountable for development and/or commercial product approvals and meeting targets; proactively identify and communicate regulatory CMC risks.
- Lead assigned global regulatory submissions (Core Dossiers, INDs, CTAs, BLAs, MAAs, Variations, etc.) through product lifecycle.
- Provide global regulatory input/support for change controls, deviations, and investigations; work in a matrix environment with GRLs and other sub-functions.
Qualifications (Minimum):
- BS/BA in a scientific discipline; advanced degree (MS/PhD) required.
- 10+ years biopharmaceutical/device industry experience with 8+ years regulatory CMC and/or devices experience; leading major submissions during LCM/development including NDA/BLA/MAA.
- Strong understanding of scientific principles and regulatory CMC requirements for global development and post-market support.
Skills/Requirements:
- Ability to understand/communicate regulatory strategy; analyze issues with attention to detail; assess alternative approaches.
- Base recommendations on precedents/regulatory intelligence plus regulations/guidelines.
- Deal with critical issues with minimal oversight; exercise sound judgment and communicate issues to line management.
- Excellent written and oral communication; emerging leadership, problem-solving, flexibility, teamwork, and inclusive culture.
- Serve as the GRA CMC Franchise Lead for TAK-079.
- Independently develop regulatory CMC strategy and lead execution of investigational, registration, and post-approval regulatory CMC strategies as GRA CMC Product Lead.
- Represent Regulatory/Pharmaceutical Development/Commercial project teams through clinical development and commercial lifecycle.
- Lead preparation of major global registrational submissions; guide strategy for CMC dossier content and ensure conformance with requirements.
- Represent Takeda GRA CMC in Health Authority meetings; drive CMC meeting preparation.
- Provide guidance on administrative/procedural topics with International Health Authorities.
- Provide strategic input into change control evaluation; ensure/enhance regulatory compliance.
- Review and provide regulatory CMC input/approval for technical protocols, reports, and related documents.
- Prepare and maintain regulatory documentation (e.g., technical regulatory strategy documents, storyboards, risk assessments); provide tactical guidance.
- Accountable for development and/or commercial product approvals and meeting targets; proactively identify and communicate regulatory CMC risks.
- Lead assigned global regulatory submissions (Core Dossiers, INDs, CTAs, BLAs, MAAs, Variations, etc.) through product lifecycle.
- Provide global regulatory input/support for change controls, deviations, and investigations; work in a matrix environment with GRLs and other sub-functions.
Qualifications (Minimum):
- BS/BA in a scientific discipline; advanced degree (MS/PhD) required.
- 10+ years biopharmaceutical/device industry experience with 8+ years regulatory CMC and/or devices experience; leading major submissions during LCM/development including NDA/BLA/MAA.
- Strong understanding of scientific principles and regulatory CMC requirements for global development and post-market support.
Skills/Requirements:
- Ability to understand/communicate regulatory strategy; analyze issues with attention to detail; assess alternative approaches.
- Base recommendations on precedents/regulatory intelligence plus regulations/guidelines.
- Deal with critical issues with minimal oversight; exercise sound judgment and communicate issues to line management.
- Excellent written and oral communication; emerging leadership, problem-solving, flexibility, teamwork, and inclusive culture.