Sr. Manager, Regulatory Affairs, CMC
Core
Implement global regulatory CMC strategy for developmental programs, focusing on oligonucleotide-based therapeutics and complex delivery systems.
Role type
Senior Manager, Regulatory Affairs CMC
Builds
Global regulatory submissions (Module 3 CMC content) for oligonucleotide and conjugate delivery therapeutics
Domain
Biotechnology / RNAi therapeutics / CMC
Deliverable
client delivery
Required skills
Regulatory strategy development, CMC data interpretation, cross-functional partnership, risk anticipation, global submission management, regulatory compliance, regulatory intelligence, infrastructure development
Preferred skills
Oligonucleotide/antibody/peptide modality experience, BLA submission experience, analytical characterization knowledge, multi-region regulatory framework knowledge
Technologies
siRNA, GalNAc, conjugate delivery systems, biologic modalities
Responsibilities
Develop and implement global regulatory CMC strategy; Interpret regulatory expectations for emerging modalities; Assess CMC implications of new technologies; Manage regulatory compliance activities; Lead preparation of Module 3 CMC content; Contribute to regulatory intelligence; Participate in regulatory CMC infrastructure development
Seniority
Senior, hands-on IC with management responsibilities
