Sr. Manager, Regulatory Affairs, CMC

Overview

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.

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.
  

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. 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
  

U.S. Pay Range

$144,400.00 - $195,400.00

The pay range reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on a number of factors including, but not limited to, relevant experience, skills, and education. This role is eligible for an annual short-term incentive award (e.g., bonus or sales incentive) and an annual long-term incentive award (e.g., equity).

Alnylam’s robust Total Rewards package is designed to support your overall health and well-being. We offer 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. We also offer generous family resources and leave. Our commitment to your well-being reflects our belief that caring for our people fuels the impact we create together.

Learn more about these and additional benefits offered by Alnylam by visiting the Benefits section of the Careers website: https://www.alnylam.com/careers

About Alnylam

We are the leader in RNAi therapeutics – a revolutionary approach with the potential to transform the lives of people with rare and common diseases. Built on Nobel Prize-winning science, Alnylam has delivered the breakthroughs that made RNAi therapeutics possible and are just at the beginning of what’s possible. Our deep pipeline, late-stage programs, and bold vision reflect our core values: fierce innovation, passion for excellence, purposeful urgency, open culture and commitment to people. We're proud to be a globally recognized top employer, where an authentic, inclusive culture and breakthrough thinking fuel one another.

At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. Qualified applicants will receive consideration for employment without regard to their sex, gender or gender identity, sexual orientation, race, color, ethnicity, national origin, ancestry, citizenship, religion, creed, physical or mental disability, pregnancy status or related conditions, genetic information, veteran or military status, marital or familial status, political affiliation, age, or any other factor protected by federal, state, or local law. Alnylam is an E-Verify Employer.