Associate Director, CMC Regulatory Affairs - Biologics

Alnylam Pharmaceuticals, Inc.; Philadelphia (Philadelphia County); Hybrid; USD 171,000 - 231,000; Full time

Benefits offered by this job

Medical, dental, and vision coverage

Paid time off and wellness days

Total Rewards package including 401(k)

Job summary

Alnylam Pharmaceuticals in the United States is seeking an Associate Director, Regulatory Affairs CMC Development to lead global CMC regulatory strategies for complex modalities, including oligonucleotide therapeutics. The role bridges Research, Development, and Regulatory Sciences to translate science into robust regulatory plans.

The position is hybrid and based in Cambridge, MA or Philadelphia, PA, requiring strong leadership, collaboration, and strategic regulatory acumen to navigate

Qualifications

• Advanced degree in chemistry, biochemistry, pharmaceutical sciences, molecular biology, or related discipline.
• Minimum 8-10 years of industry experience in pharmaceutical/biotechnology with at least 5 years in Regulatory Affairs CMC.
• Ability to interpret complex technical, nonclinical, clinical, and manufacturing information into regulatory strategies.
• Experience with regulatory submissions and health authority interactions for development-stage programs.
• Strong communication, collaboration, and cross-functional leadership skills.

Responsibilities

• Lead global CMC regulatory strategies for small molecules, biologics, and complex modalities across development stages.
• Plan, review, and prepare CMC documentation for clinical trials and marketing applications.
• Interpret regulatory expectations for emerging modalities including oligonucleotide therapeutics and conjugated delivery systems.
• Serve as a strategic interface between Research, Development, Operations, and Regulatory Sciences.
• Provide guidance on product characterization, control strategies, and regulatory classification considerations.
• Represent Regulatory Affairs CMC in governance and portfolio discussions.
• Identify regulatory risks with technical teams and develop mitigation strategies.
• Contribute to regulatory intelligence and evolving policy interpretation.
• Help build Regulatory Affairs CMC infrastructure, processes, and capability.

Skills

Regulatory strategy

Cross-functional leadership

Communication skills

Project management

Education

Advanced degree in chemistry/biochemistry/pharmaceutical sciences/molecular biology

Job description

Alnylam Pharmaceuticals in the United States is seeking an Associate Director, Regulatory Affairs CMC Development to lead global CMC regulatory strategies for complex modalities, including oligonucleotide therapeutics. The role bridges Research, Development, and Regulatory Sciences to translate science into robust regulatory plans.

The position is hybrid and based in Cambridge, MA or Philadelphia, PA, requiring strong leadership, collaboration, and strategic regulatory acumen to navigate