Executive Director, Global Regulatory Affairs CMC Early Development
Takeda
August 07, 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:
- Provide strategic 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, data/knowledge management, digital CMC dossiers).
- Lead global CMC regulatory strategy and key submissions/health authority interactions for an assigned portfolio (FIH to pre-pivotal); ensure governance and stakeholder alignment.
- Represent Global Regulatory Affairs CMC with senior governance and global health authorities (e.g., FDA, EMA, MHRA, PMDA), enabling pathways such as pre-IND/IND/CTA, amendments, Type B/C meetings, and scientific advice.
- Ensure global CMC content quality/compliance for early development submissions and Phase 2 lifecycle changes (e.g., IND/CTA, IMPD quality sections, responses to health authority questions).
- Provide CMC regulatory leadership for due diligence/business development; monitor trends (e.g., ICH Q12/Q13/Q14/Q2(R2), nitrosamines, elemental impurities) and translate into proactive strategies.
Qualifications & Skills:
- Advanced degree (MS, PhD, PharmD) in scientific/engineering discipline.
- 20+ years industry experience; significant Global Regulatory Affairs CMC experience; leadership in early development for small molecules and/or biologics.
- Proven experience leading/reviewing/authoring/managing CMC submission content and responses (pre-IND/IND, CTA/IMPD, amendments, briefing packages, deficiency responses) and negotiating with health authorities.
- Strong knowledge of global CMC requirements (ICH + FDA/EMA/MHRA/PMDA; additional regions preferred).
- Experience integrating in silico modeling/simulation and digital data strategies into CMC justifications (strongly preferred).
- Excellent communication, negotiation, strategic thinking, global cross-functional leadership, and ability to distill complex issues.
- Demonstrated fit-for-phase, risk-based regulatory strategy leadership; work effectively in global teams.
Responsibilities:
- Provide strategic 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, data/knowledge management, digital CMC dossiers).
- Lead global CMC regulatory strategy and key submissions/health authority interactions for an assigned portfolio (FIH to pre-pivotal); ensure governance and stakeholder alignment.
- Represent Global Regulatory Affairs CMC with senior governance and global health authorities (e.g., FDA, EMA, MHRA, PMDA), enabling pathways such as pre-IND/IND/CTA, amendments, Type B/C meetings, and scientific advice.
- Ensure global CMC content quality/compliance for early development submissions and Phase 2 lifecycle changes (e.g., IND/CTA, IMPD quality sections, responses to health authority questions).
- Provide CMC regulatory leadership for due diligence/business development; monitor trends (e.g., ICH Q12/Q13/Q14/Q2(R2), nitrosamines, elemental impurities) and translate into proactive strategies.
Qualifications & Skills:
- Advanced degree (MS, PhD, PharmD) in scientific/engineering discipline.
- 20+ years industry experience; significant Global Regulatory Affairs CMC experience; leadership in early development for small molecules and/or biologics.
- Proven experience leading/reviewing/authoring/managing CMC submission content and responses (pre-IND/IND, CTA/IMPD, amendments, briefing packages, deficiency responses) and negotiating with health authorities.
- Strong knowledge of global CMC requirements (ICH + FDA/EMA/MHRA/PMDA; additional regions preferred).
- Experience integrating in silico modeling/simulation and digital data strategies into CMC justifications (strongly preferred).
- Excellent communication, negotiation, strategic thinking, global cross-functional leadership, and ability to distill complex issues.
- Demonstrated fit-for-phase, risk-based regulatory strategy leadership; work effectively in global teams.