Regulatory Compliance & Inspection Readiness Lead

Alnylam Pharmaceuticals; Cambridge (MA); Hybrid; USD 135,000 - 183,000; Full time

Job summary

Alnylam Pharmaceuticals is seeking a Senior Manager, Regulatory Sciences Compliance to build and oversee the regulatory sciences compliance framework across Strategy, Operations, Labeling, Global Safety, and Medical Safety. The role ensures alignment with regulatory requirements and inspection readiness while driving risk management and continuous improvement.

Hybrid work and Cambridge, MA location offered.

Qualifications

• Bachelor's degree in Regulatory Affairs, Life Sciences, Pharmacy or related field; advanced degree preferred.
• Minimum of 4 years of experience in pharmaceutical or biotechnology industry.
• Strong knowledge of global regulatory frameworks and Quality Management System expectations.
• Experience supporting regulatory inspections and internal audits strongly preferred.
• Experience working within a Quality Management System environment and supporting cross-functional compliance governance.
• Excellent written and verbal communication; able to express complex ideas.

Responsibilities

• Provide compliance oversight across Regulatory Science activities and related subfunctions.
• Define, maintain, and monitor KPIs and compliance metrics for Regulatory Sciences.
• Support deviations, CAPAs, and quality issues with root-cause analysis and remediation.

Skills

Leadership

Project management

Regulatory governance

Communication

Education

Bachelor's in Regulatory Affairs

Licensed healthcare professional

Job description

Alnylam Pharmaceuticals is seeking a Senior Manager, Regulatory Sciences Compliance to build and oversee the regulatory sciences compliance framework across Strategy, Operations, Labeling, Global Safety, and Medical Safety. The role ensures alignment with regulatory requirements and inspection readiness while driving risk management and continuous improvement.

Hybrid work and Cambridge, MA location offered.