Sr. Manager, Regulatory Affairs, CMC

About the role

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.

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, and 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, and regulatory classification considerations.
• 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.

Qualifications

• 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.
• 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, and regulatory framework across major regions.
• Strong ability to integrate scientific, technical, and regulatory considerations into clear strategies.

Pay

The pay range for this role is $144,400.00 - $195,400.00, and is eligible for an annual short-term incentive award and an annual long-term incentive award.

Benefits

Alnylam offers comprehensive benefits including medical, dental, and vision coverage, life and disability insurance, a lifestyle reimbursement program, flexible spending and health savings accounts, and a 401(k) with a generous company match. Eligible employees enjoy paid time off, wellness days, holidays, and two company-wide recharge breaks, as well as generous family resources and leave.