Associate Director - Regulatory Affairs, CMC-Biologics

Overview

The Associate Director, Regulatory Affairs CMC Development is responsible for developing and implementing global CMC regulatory strategies for development-stage programs. This role will play a critical part in shaping regulatory strategies for emerging therapeutic modalities, with an emphasis on oligonucleotide-based therapeutics, including siRNA, antibody drug conjugates, and next-generation delivery systems. 

This role serves as a key bridge between Research, Pharmaceutical Development, Technical Operations, and Regulatory Sciences, helping to translate evolving science into effective global regulatory CMC strategies. The Associate Director will bring a broad scientific foundation in biologics and/or complex modalities, along with strong communication, collaboration, and project management skills. This individual will play an important role in evaluating the regulatory implications of novel technologies and guiding development teams through an evolving global regulatory landscape.

This position is hybrid and primarily located in our Cambridge, MA or Philadelphia, PA office.

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.
• 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.

#LI-JB1

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.

Before applying, please review Alnylam's ⁠Candidate Privacy Notice regarding how Alnylam handles Personal Data you provide with your application for employment.

U.S. Pay Range 170900 - 231300 USD