Associate Director, Regulatory Affairs, CMC
Core
Develop and implement global CMC regulatory strategies for development-stage programs, focusing on emerging therapeutic modalities like oligonucleotide-based therapeutics, siRNA, and antibody drug conjugates.
Role type
Associate Director, Regulatory Affairs CMC
Builds
Global regulatory strategies for small molecules, biologics, and complex modalities
Domain
Biopharmaceuticals / Regulatory Affairs / CMC
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
CMC regulatory strategy development, clinical trial application documentation, marketing authorization application preparation, health authority briefing package creation, regulatory interpretation for emerging modalities, cross-functional leadership, technical information translation, regulatory risk identification, regulatory intelligence analysis, process infrastructure building
Preferred skills
Experience with oligonucleotide therapeutics, conjugated delivery systems, antibody-drug conjugates, peptide conjugates, biologic or hybrid modalities
Technologies
GalNAc, targeting ligands
Responsibilities
Lead development and execution of global CMC regulatory strategies for innovative small molecules, biologics, and complex modalities; Plan, review, and prepare CMC documentation for clinical trial applications, marketing authorization applications, and health authority briefing packages; Lead or help lead interpretation of regulatory expectations for emerging modalities; Serve as strategic interface between Research, Pharmaceutical Development, Technical Operations, and Regulatory Sciences; Provide strategic guidance on product characterization, control strategies, comparability approaches, and regulatory classification considerations; Represent Regulatory Affairs CMC in cross-functional governance, development, and portfolio discussions; Partner with technical teams to identify regulatory risks and develop proactive mitigation strategies; Contribute to regulatory intelligence activities and interpretation of evolving policy for novel modalities; Help build Regulatory Affairs CMC infrastructure, processes, and organizational capability
Seniority
Senior, hands-on IC with strategic oversight