Associate Director, Regulatory Affairs, CMC

About the role

This role is responsible for developing and implementing global CMC regulatory strategies for development-stage programs, with a focus on oligonucleotide-based therapeutics, including siRNA, antibody drug conjugates, and next-generation delivery systems. The Associate Director serves as a key bridge between Research, Pharmaceutical Development, Technical Operations, and Regulatory Sciences, translating evolving science into effective global regulatory CMC strategies. This position is hybrid and primarily located in our Cambridge, MA or Philadelphia, PA office.

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.
• Lead or help to lead the interpretation of regulatory expectations for emerging modalities, including oligonucleotide therapeutics, conjugated delivery systems (e.g., GalNAc and other targeting ligands), antibody-drug conjugates, peptide conjugates, and biologic or hybrid modalities.
• Serve as a strategic interface between Research, Pharmaceutical Development, Technical Operations, and Regulatory Sciences.
• Provide strategic guidance on product characterization, control strategies, comparability approaches, and regulatory classification considerations.
• Represent Regulatory Affairs CMC in cross-functional governance, development, and portfolio discussions.
• Partner with technical teams to identify regulatory risks and develop proactive mitigation strategies.
• Contribute to regulatory intelligence activities 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.
• Demonstrated experience supporting therapeutic products through multiple stages of development.
• Minimum 8-10 years of industry experience in the pharmaceutical/biotechnology industry, including at least 5 years of Regulatory Affairs CMC experience.
• Ability to interpret complex technical, nonclinical, clinical, and manufacturing information and translate it into clear regulatory strategies.
• Experience with regulatory submissions and health authority interactions for development-stage programs.
• Strong communication, collaboration, and cross-functional leadership skills.
• Ability to evaluate emerging technologies and apply sound regulatory judgment in a fast-paced, evolving environment.
• Strong ability to integrate scientific, technical, and regulatory considerations into clear actionable strategies.

Pay

U.S. Pay Range: $170,900.00 - $231,300.00. The pay range reflects the full-time base salary range expected for this role at the time of posting. Base pay will be determined based on 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).

Benefits

• Comprehensive medical, dental, and vision coverage.
• Life and disability insurance.
• Lifestyle reimbursement program.
• Flexible spending and health savings accounts.
• 401(k) with a generous company match.
• Paid time off, wellness days, holidays, and two company-wide recharge breaks.
• Generous family resources and leave.

About Alnylam

Alnylam is 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 breakthroughs that made RNAi therapeutics possible and continues to pioneer new possibilities. The company’s deep pipeline and late-stage programs reflect core values of fierce innovation, passion for excellence, purposeful urgency, open culture, and commitment to people.