Executive Director, Global Regulatory Affairs CMC Early Development
Takeda
June 25, 2026
Remote friendly (Boston, MA)
United States
$238,000 - $374,000 USD yearly
Corporate Functions
Executive Director, Global Regulatory Affairs CMC Early Development (GRA CMC ED)
Responsibilities/Objectives:
- Provide strategic leadership and people leadership to deliver compliant global CMC regulatory strategies and submissions for small molecule and biologic products through Phase 2.
- Champion fit-for-phase CMC approaches and advance in silico/digital innovation (modeling/simulation, predictive tools, knowledge/data management, digital CMC dossiers) to strengthen scientific justifications, improve speed, and enable right-first-time submissions.
- Establish best practices and build a regulatory community across Global Regulatory Affairs and CMC functions to ensure consistent, high-quality execution.
- Oversee global CMC regulatory strategy and key submissions/health authority interactions (FIH to pre-pivotal) and align CMC development plans to regional expectations and timelines.
- Ensure governance teams are apprised of CMC developments affecting regulatory success; anticipate risks and drive mitigation consistent with quality risk management.
- Represent GRA CMC in senior governance and interactions with regulators (e.g., FDA, EMA, MHRA, PMDA) for pre-IND/IND/CTA, amendments, Type B/C meetings, and scientific advice.
- Lead fit-for-phase/platform initiatives, harmonize templates/positions, improve knowledge management, and support accelerated programs.
- Provide early CMC regulatory strategy leadership for business development/due diligence.
Qualifications/Skills (required/preferred):
- Advanced degree in a scientific/engineering discipline (MS, PhD, PharmD).
- 20+ years industry experience with significant Global Regulatory Affairs CMC experience; leadership for small molecule and/or biologics in early development.
- Significant experience leading/reviewing/authoring/managing CMC content for global submissions (pre-IND/IND, CTA/IMPD, amendments, briefing packages, deficiency responses) and negotiating with health authorities.
- Strong knowledge of global small molecule/biologic CMC requirements and ICH/regional expectations (FDA/EMA/MHRA/PMDA); additional regions a plus.
- Strong oral/written communication, negotiation, integrity, adaptability; strategic thinking and ability to operate independently.
- Strongly preferred: experience integrating in silico modeling/simulation and digital data strategies into CMC justifications.
Benefits/Compensation:
- U.S. base salary range (Boston, MA): $238,000.00–$374,000.00; may be eligible for incentives and benefits (medical/dental/vision, 401(k) match, disability, life insurance, tuition reimbursement, paid time off, holidays, well-being; up to 80 hours sick time; up to 120 hours paid vacation for new hires).
Application instructions:
- Apply via the “Apply” button (understand application processing per Takeda Privacy Notice and Terms of Use).
Responsibilities/Objectives:
- Provide strategic leadership and people leadership to deliver compliant global CMC regulatory strategies and submissions for small molecule and biologic products through Phase 2.
- Champion fit-for-phase CMC approaches and advance in silico/digital innovation (modeling/simulation, predictive tools, knowledge/data management, digital CMC dossiers) to strengthen scientific justifications, improve speed, and enable right-first-time submissions.
- Establish best practices and build a regulatory community across Global Regulatory Affairs and CMC functions to ensure consistent, high-quality execution.
- Oversee global CMC regulatory strategy and key submissions/health authority interactions (FIH to pre-pivotal) and align CMC development plans to regional expectations and timelines.
- Ensure governance teams are apprised of CMC developments affecting regulatory success; anticipate risks and drive mitigation consistent with quality risk management.
- Represent GRA CMC in senior governance and interactions with regulators (e.g., FDA, EMA, MHRA, PMDA) for pre-IND/IND/CTA, amendments, Type B/C meetings, and scientific advice.
- Lead fit-for-phase/platform initiatives, harmonize templates/positions, improve knowledge management, and support accelerated programs.
- Provide early CMC regulatory strategy leadership for business development/due diligence.
Qualifications/Skills (required/preferred):
- Advanced degree in a scientific/engineering discipline (MS, PhD, PharmD).
- 20+ years industry experience with significant Global Regulatory Affairs CMC experience; leadership for small molecule and/or biologics in early development.
- Significant experience leading/reviewing/authoring/managing CMC content for global submissions (pre-IND/IND, CTA/IMPD, amendments, briefing packages, deficiency responses) and negotiating with health authorities.
- Strong knowledge of global small molecule/biologic CMC requirements and ICH/regional expectations (FDA/EMA/MHRA/PMDA); additional regions a plus.
- Strong oral/written communication, negotiation, integrity, adaptability; strategic thinking and ability to operate independently.
- Strongly preferred: experience integrating in silico modeling/simulation and digital data strategies into CMC justifications.
Benefits/Compensation:
- U.S. base salary range (Boston, MA): $238,000.00–$374,000.00; may be eligible for incentives and benefits (medical/dental/vision, 401(k) match, disability, life insurance, tuition reimbursement, paid time off, holidays, well-being; up to 80 hours sick time; up to 120 hours paid vacation for new hires).
Application instructions:
- Apply via the “Apply” button (understand application processing per Takeda Privacy Notice and Terms of Use).