Executive Director, Global Regulatory Affairs CMC Early Development
Takeda
August 29, 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 and people leadership to deliver innovative, compliant global CMC regulatory strategies and submissions for small molecule and biologic products through Phase 2 development.
- Advance fit-for-phase CMC approaches and adoption of in silico/digital innovation (modeling/simulation, predictive tools, data/knowledge management, digital CMC dossiers).
- Lead global CMC regulatory subject matter experts; establish best practices and a strong regulatory community across CMC/regulatory functions.
- Oversee global CMC strategy and health authority interactions (e.g., pre-IND/IND/CTA, amendments, Type B/C meetings, scientific advice).
- Ensure inspection-ready, high-quality global CMC content and compliance for early development submissions and lifecycle changes (IND/CTA modules, IMPD quality sections, responses).
- Lead initiatives for platform approaches, knowledge management, harmonized templates, and accelerated program readiness.
Qualifications/Skills (required/preferred):
- Advanced degree (MS/PhD/PharmD) in scientific/engineering discipline.
- 20+ years industry experience with significant Global Regulatory Affairs CMC; leadership in early development for small molecules and/or biologics.
- Significant experience authoring/reviewing/managing global CMC submission content and negotiating with health authorities.
- Strong working knowledge of small molecule/biologic CMC and global/regional regulatory expectations (ICH; FDA/EMA/MHRA/PMDA).
- Strong oral/written communication; strategic, independent, risk-based problem solving; cross-functional/global team leadership.
- Strongly preferred: experience integrating in silico modeling/simulation and digital data strategies into CMC justifications.
Benefits (explicitly stated):
- Eligible for medical/dental/vision, 401(k) with match, disability and life insurance, tuition reimbursement, paid volunteer time off, holidays, and well-being benefits; up to 80 hours sick time/year; up to 120 hours paid vacation for new hires.
Location/Work type:
- Boston, MA; hybrid; full-time; employee (regular), exempt.
Responsibilities/Objectives:
- Provide strategic and people leadership to deliver innovative, compliant global CMC regulatory strategies and submissions for small molecule and biologic products through Phase 2 development.
- Advance fit-for-phase CMC approaches and adoption of in silico/digital innovation (modeling/simulation, predictive tools, data/knowledge management, digital CMC dossiers).
- Lead global CMC regulatory subject matter experts; establish best practices and a strong regulatory community across CMC/regulatory functions.
- Oversee global CMC strategy and health authority interactions (e.g., pre-IND/IND/CTA, amendments, Type B/C meetings, scientific advice).
- Ensure inspection-ready, high-quality global CMC content and compliance for early development submissions and lifecycle changes (IND/CTA modules, IMPD quality sections, responses).
- Lead initiatives for platform approaches, knowledge management, harmonized templates, and accelerated program readiness.
Qualifications/Skills (required/preferred):
- Advanced degree (MS/PhD/PharmD) in scientific/engineering discipline.
- 20+ years industry experience with significant Global Regulatory Affairs CMC; leadership in early development for small molecules and/or biologics.
- Significant experience authoring/reviewing/managing global CMC submission content and negotiating with health authorities.
- Strong working knowledge of small molecule/biologic CMC and global/regional regulatory expectations (ICH; FDA/EMA/MHRA/PMDA).
- Strong oral/written communication; strategic, independent, risk-based problem solving; cross-functional/global team leadership.
- Strongly preferred: experience integrating in silico modeling/simulation and digital data strategies into CMC justifications.
Benefits (explicitly stated):
- Eligible for medical/dental/vision, 401(k) with match, disability and life insurance, tuition reimbursement, paid volunteer time off, holidays, and well-being benefits; up to 80 hours sick time/year; up to 120 hours paid vacation for new hires.
Location/Work type:
- Boston, MA; hybrid; full-time; employee (regular), exempt.