Associate Director, Regulatory Affairs, CMC
Alnylam Pharmaceuticals
August 14, 2026
Remote friendly (Cambridge, MA)
United States
Corporate Functions
Key Responsibilities
- Lead the development and execution of global CMC regulatory strategies for innovative small molecules, biologics, and complex modalities across early- and late-stage development.
- Plan, review, and prepare CMC documentation for clinical trial applications, marketing authorization applications, and health authority briefing packages.
- Interpret regulatory expectations for emerging modalities, including oligonucleotide therapeutics (e.g., siRNA), conjugated delivery systems (e.g., GalNAc and targeting ligands), antibody-drug conjugates, peptide conjugates, and biologic/hybrid modalities.
- Serve as a strategic interface between Research, Pharmaceutical Development, Technical Operations, and Regulatory Sciences.
- Provide guidance on product characterization, control strategies, comparability approaches, and regulatory classification.
- Represent Regulatory Affairs CMC in cross-functional governance, development, and portfolio discussions.
- Partner with technical teams to identify regulatory risks and develop mitigation strategies.
- Contribute to regulatory intelligence and interpretation of evolving policy for novel modalities.
- Help build Regulatory Affairs CMC infrastructure, processes, and organizational capability.
Qualifications
- Advanced degree in chemistry, biochemistry, pharmaceutical sciences, molecular biology, or related discipline.
- Experience supporting therapeutic products through multiple stages of development.
- 8–10 years industry experience (pharma/biotech), including 5+ years Regulatory Affairs CMC.
- Ability to translate complex technical/nonclinical/clinical/manufacturing information into regulatory strategies.
- Experience with regulatory submissions and health authority interactions for development-stage programs.
- Strong communication, collaboration, and cross-functional leadership.
- Ability to evaluate emerging technologies and apply regulatory judgment in a fast-paced environment.
- Lead the development and execution of global CMC regulatory strategies for innovative small molecules, biologics, and complex modalities across early- and late-stage development.
- Plan, review, and prepare CMC documentation for clinical trial applications, marketing authorization applications, and health authority briefing packages.
- Interpret regulatory expectations for emerging modalities, including oligonucleotide therapeutics (e.g., siRNA), conjugated delivery systems (e.g., GalNAc and targeting ligands), antibody-drug conjugates, peptide conjugates, and biologic/hybrid modalities.
- Serve as a strategic interface between Research, Pharmaceutical Development, Technical Operations, and Regulatory Sciences.
- Provide guidance on product characterization, control strategies, comparability approaches, and regulatory classification.
- Represent Regulatory Affairs CMC in cross-functional governance, development, and portfolio discussions.
- Partner with technical teams to identify regulatory risks and develop mitigation strategies.
- Contribute to regulatory intelligence and interpretation of evolving policy for novel modalities.
- Help build Regulatory Affairs CMC infrastructure, processes, and organizational capability.
Qualifications
- Advanced degree in chemistry, biochemistry, pharmaceutical sciences, molecular biology, or related discipline.
- Experience supporting therapeutic products through multiple stages of development.
- 8–10 years industry experience (pharma/biotech), including 5+ years Regulatory Affairs CMC.
- Ability to translate complex technical/nonclinical/clinical/manufacturing information into regulatory strategies.
- Experience with regulatory submissions and health authority interactions for development-stage programs.
- Strong communication, collaboration, and cross-functional leadership.
- Ability to evaluate emerging technologies and apply regulatory judgment in a fast-paced environment.