Executive Director, Global Regulatory Affairs CMC Early Development

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. #J-18808-Ljbffr