Sr. Manager, Regulatory Affairs, CMC

Alnylam Pharmaceuticals•Cambridge, MA

15h•Hybrid

About The Position

The Senior Manager, Regulatory Affairs CMC Development is responsible for implementation of the global regulatory CMC strategy for developmental programs. This role will play a critical part in shaping regulatory strategies for emerging and complex modalities, with an emphasis on oligonucleotide-based therapeutics, including siRNA and novel conjugate delivery systems. The Senior Manager will bring a broad scientific foundation and the ability to translate complex CMC data into clear regulatory strategies. The Senior Manager will partner cross-functionally to define developmental pathways, anticipate regulatory risks, and enable efficient global submissions. This position reports to the Director of Regulatory Affairs CMC, or equivalent. This position is hybrid and will be primarily located in Cambridge, MA.

Requirements

Advanced degree in chemistry, biochemistry, pharmaceutical sciences, molecular biology, or related field.
Minimum 4-6 years of experience in the pharmaceutical/biotechnology/life science industry, including at least 2 years of Regulatory Affairs CMC experience. Equivelant technical experience may be substituted for direct experience in Regulatory Affairs experience.
Experience supporting oligonucleotide, antibody, peptide or other complex modalities strongly preferred.
Ability to quickly understand and evaluate new technologies.
Strong communication skills with the ability to translate complex technical concepts into clear regulatory positions.
Agility – must be able to thrive in an evolving, fast-paced environment with emerging science.
Experience with BLA submissions or content generation preferred.
Broad understanding of: Drug substance and drug product development, Analytical characterization and control strategies, Regulatory framework across major regions (e.g., US, EU, Japan, China)
Strong ability to integrate scientific, technical, and regulatory considerations into clear strategies

Responsibilities

Contributes to the development and implementation of the global regulatory CMC strategy for developmental programs.
Helps to lead the interpretation of regulatory expectations for emerging modalities, including: siRNA and oligonucleotide therapeutics, Conjugated delivery systems (e.g., GalNAc and other targeting ligands including biologic modalities), Complex drug substance and drug product configurations
Helps to assess CMC implications of new technologies and modalities, including: Impact on product characterization, control strategies, and specifications, Regulatory classification considerations (e.g., small-molecule vs biologic paradigms)
Manages regulatory compliance activities including periodic regulatory reporting, review of technical documents, and providing regulatory assessments.
Leads and manages the preparation of Module 3 (CMC) content supporting global submissions.
Contributes to regulatory intelligence and policy interpretation for novel modalities.
Actively participates in the development of regulatory CMC infrastructure and capability building.