Executive Director, Global Regulatory Affairs CMC Early Development
Takeda
2 months ago
Remote friendly (Cambridge, MA)
United States
Corporate Functions
How you will contribute:
- Leads and develops a team of regulatory leaders and subject matter experts; oversees global CMC regulatory strategy and key submissions/health authority interactions for a portfolio of small molecule and biologic products through Phase 2.
- Partners with cross-functional leaders (CMC, Regulatory, Development, Clinical, Nonclinical, Quality, Safety, Manufacturing, Supply Chain, Digital/Data) to align CMC development plans with regional regulatory expectations and program timelines.
- Keeps governance teams and stakeholders apprised of CMC developments impacting regulatory success (e.g., process/formulation changes, analytical readiness, control strategy evolution, comparability considerations, starting material strategy, impurity risk, raw material/supply risk); anticipates risks and drives mitigation consistent with quality risk management.
- Represents Global Regulatory Affairs CMC in senior-level governance and interactions with health authorities (e.g., FDA, EMA, MHRA, PMDA), including pre-IND/IND/CTA, amendments, Type B/C meetings, and scientific advice.
- Ensures global CMC content quality and compliance for early development submissions and lifecycle changes through Phase 2 (e.g., IND/CTA modules, IMPD quality sections, amendments, investigator’s brochure CMC, responses to health authority questions), partnering to produce inspection-ready documentation.
- Leads initiatives to advance fit-for-phase and platform approaches in early development CMC (global harmonization of templates/positions, improved knowledge management, readiness for accelerated programs).
- Provides CMC regulatory strategy leadership for business development and due diligence.
- Monitors global regulatory trends (e.g., ICH Q12/Q13/Q14/Q2(R2), nitrosamines, elemental impurities, biologics comparability; modeling/simulation and structured data).
- Champions in silico and digital capabilities in CMC (predictive impurity risk, process/formulation modeling, PBPK/biopharmaceutics linkages as relevant, digital data lineage, content re-use).
- Demonstrates leadership behaviors.
Minimum Requirements/Qualifications:
- Advanced degree in a scientific or engineering discipline (e.g., MS, PhD, PharmD).
- 20+ years of industry experience, including significant Global Regulatory Affairs CMC experience and leadership for small molecule and/or biologic products in early development.
- Significant experience leading/reviewing/authoring/managing CMC content for global regulatory submissions and responses in early development (pre-IND/IND, CTA/IMPD, amendments, briefing packages, major deficiency responses) and negotiating with health authorities.
- Strong working knowledge of small molecule and/or biologic CMC development and global regulatory requirements, including ICH and regional expectations (FDA, EMA, MHRA, PMDA; additional regions a plus).
- Ability to interpret complex technical, nonclinical, clinical, and manufacturing issues related to CMC strategy (impurity risk, analytical control strategy, specifications, stability strategy, comparability as applicable).
- Demonstrated ability to drive fit-for-phase global CMC regulatory strategy; in silico modeling/simulation and digital data integration strongly preferred.
- Strong oral/written communication; manages timelines; negotiation skills; integrity and adaptability.
- Strategic thinking with increasing independence; proactively identifies CMC regulatory issues and proposes innovative, risk-based solutions.
- Works effectively with global teams and can bring teams together for common objectives.
- Leads and develops a team of regulatory leaders and subject matter experts; oversees global CMC regulatory strategy and key submissions/health authority interactions for a portfolio of small molecule and biologic products through Phase 2.
- Partners with cross-functional leaders (CMC, Regulatory, Development, Clinical, Nonclinical, Quality, Safety, Manufacturing, Supply Chain, Digital/Data) to align CMC development plans with regional regulatory expectations and program timelines.
- Keeps governance teams and stakeholders apprised of CMC developments impacting regulatory success (e.g., process/formulation changes, analytical readiness, control strategy evolution, comparability considerations, starting material strategy, impurity risk, raw material/supply risk); anticipates risks and drives mitigation consistent with quality risk management.
- Represents Global Regulatory Affairs CMC in senior-level governance and interactions with health authorities (e.g., FDA, EMA, MHRA, PMDA), including pre-IND/IND/CTA, amendments, Type B/C meetings, and scientific advice.
- Ensures global CMC content quality and compliance for early development submissions and lifecycle changes through Phase 2 (e.g., IND/CTA modules, IMPD quality sections, amendments, investigator’s brochure CMC, responses to health authority questions), partnering to produce inspection-ready documentation.
- Leads initiatives to advance fit-for-phase and platform approaches in early development CMC (global harmonization of templates/positions, improved knowledge management, readiness for accelerated programs).
- Provides CMC regulatory strategy leadership for business development and due diligence.
- Monitors global regulatory trends (e.g., ICH Q12/Q13/Q14/Q2(R2), nitrosamines, elemental impurities, biologics comparability; modeling/simulation and structured data).
- Champions in silico and digital capabilities in CMC (predictive impurity risk, process/formulation modeling, PBPK/biopharmaceutics linkages as relevant, digital data lineage, content re-use).
- Demonstrates leadership behaviors.
Minimum Requirements/Qualifications:
- Advanced degree in a scientific or engineering discipline (e.g., MS, PhD, PharmD).
- 20+ years of industry experience, including significant Global Regulatory Affairs CMC experience and leadership for small molecule and/or biologic products in early development.
- Significant experience leading/reviewing/authoring/managing CMC content for global regulatory submissions and responses in early development (pre-IND/IND, CTA/IMPD, amendments, briefing packages, major deficiency responses) and negotiating with health authorities.
- Strong working knowledge of small molecule and/or biologic CMC development and global regulatory requirements, including ICH and regional expectations (FDA, EMA, MHRA, PMDA; additional regions a plus).
- Ability to interpret complex technical, nonclinical, clinical, and manufacturing issues related to CMC strategy (impurity risk, analytical control strategy, specifications, stability strategy, comparability as applicable).
- Demonstrated ability to drive fit-for-phase global CMC regulatory strategy; in silico modeling/simulation and digital data integration strongly preferred.
- Strong oral/written communication; manages timelines; negotiation skills; integrity and adaptability.
- Strategic thinking with increasing independence; proactively identifies CMC regulatory issues and proposes innovative, risk-based solutions.
- Works effectively with global teams and can bring teams together for common objectives.