Sr. Manager, Regulatory Affairs, CMC
Alnylam Pharmaceuticals
June 25, 2026
Remote friendly (Cambridge, MA)
United States
Corporate Functions
Responsibilities:
- Contribute to the development and implementation of the global regulatory CMC strategy for developmental programs.
- Interpret regulatory expectations for emerging modalities, including siRNA/oligonucleotide therapeutics, conjugated delivery systems (e.g., GalNAc and other targeting ligands including biologic modalities), and complex drug substance/drug product configurations.
- Assess CMC implications of new technologies (e.g., impact on product characterization, control strategies, specifications; regulatory classification considerations such as small-molecule vs biologic paradigms).
- Manage regulatory compliance activities (periodic regulatory reporting, review of technical documents, regulatory assessments).
- Lead preparation of Module 3 (CMC) content supporting global submissions.
- Contribute to regulatory intelligence and policy interpretation for novel modalities.
- Participate in development of regulatory CMC infrastructure and capability building.
Qualifications:
- Advanced degree in chemistry, biochemistry, pharmaceutical sciences, molecular biology, or related field.
- 4–6 years in pharmaceutical/biotechnology/life sciences with at least 2 years Regulatory Affairs CMC experience (equivalent technical experience may substitute).
- Strongly preferred: experience supporting oligonucleotide, antibody, peptide, or other complex modalities.
- Ability to quickly evaluate new technologies.
- Strong communication skills translating complex technical concepts into clear regulatory positions.
- Agility in a fast-paced, evolving environment with emerging science.
- Preferred: experience with BLA submissions or content generation.
- Broad understanding of drug substance/drug product development, analytical characterization/control strategies, and regulatory frameworks across major regions (US, EU, Japan, China).
- Contribute to the development and implementation of the global regulatory CMC strategy for developmental programs.
- Interpret regulatory expectations for emerging modalities, including siRNA/oligonucleotide therapeutics, conjugated delivery systems (e.g., GalNAc and other targeting ligands including biologic modalities), and complex drug substance/drug product configurations.
- Assess CMC implications of new technologies (e.g., impact on product characterization, control strategies, specifications; regulatory classification considerations such as small-molecule vs biologic paradigms).
- Manage regulatory compliance activities (periodic regulatory reporting, review of technical documents, regulatory assessments).
- Lead preparation of Module 3 (CMC) content supporting global submissions.
- Contribute to regulatory intelligence and policy interpretation for novel modalities.
- Participate in development of regulatory CMC infrastructure and capability building.
Qualifications:
- Advanced degree in chemistry, biochemistry, pharmaceutical sciences, molecular biology, or related field.
- 4–6 years in pharmaceutical/biotechnology/life sciences with at least 2 years Regulatory Affairs CMC experience (equivalent technical experience may substitute).
- Strongly preferred: experience supporting oligonucleotide, antibody, peptide, or other complex modalities.
- Ability to quickly evaluate new technologies.
- Strong communication skills translating complex technical concepts into clear regulatory positions.
- Agility in a fast-paced, evolving environment with emerging science.
- Preferred: experience with BLA submissions or content generation.
- Broad understanding of drug substance/drug product development, analytical characterization/control strategies, and regulatory frameworks across major regions (US, EU, Japan, China).