Regulatory Quality & Compliance Lead

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

Job summary

Alnylam Pharmaceuticals seeks a Senior Manager, Regulatory Sciences Compliance to lead the regulatory sciences compliance framework and provide oversight across Regulatory Strategy, Operations, Labeling, Global Safety Operations, Medical Safety, and Risk Management. Hybrid role, primarily located in Cambridge, MA, USA.

You will drive KPIs, manage deviations and CAPAs, and coordinate QA interfaces and inspections while partnering with cross-functional teams to ensure GMP/GDP alignment and

Qualifications

• Bachelor's degree in Regulatory Affairs, Life Sciences, Pharmacy, or related field and/or a licensed healthcare professional (advanced degree preferred).
• Minimum of 4 years of experience in pharmaceutical or biotechnology industry.
• Strong knowledge of global regulatory frameworks, regulatory operations processes, and Quality Management System expectations.
• Significant experience in Regulatory Affairs and/or pharmacovigilance compliance or related quality/compliance functions.
• Experience supporting regulatory inspections and internal audits strongly preferred.
• Experience working within a Quality Management System environment and supporting cross-functional compliance governance.
• Demonstrated ability to partner with functional process owners while maintaining independent oversight and quality standards.
• Excellent leadership and project management skills; can establish and maintain effective relationships with customers (internal and external)
• Excellent written and verbal communication skills. Able to express complex ideas.
• Ability to work independently, prioritize effectively and work in a matrix team environment required.

Responsibilities

• Provide compliance governance across Regulatory Science subfunctions.
• Define and monitor KPIs and compliance metrics for Regulatory Sciences activities.
• Support deviations, CAPAs, and quality issues related to Regulatory Sciences activities.
• Coordinate internal audits and regulatory inspection responses for Regulatory Sciences.
• Support inspection readiness initiatives and remediation planning.
• Drive continuous improvement initiatives to strengthen regulatory sciences compliance.

Skills

Leadership

Project management

Regulatory knowledge

Communication

Matrix collaboration

Education

Bachelor's degree in Regulatory Affairs, Life Sciences, Pharmacy, or related field

Licensed healthcare professional (adv. degree preferred)

Tools

Quality Management System (QMS)

Job description

Alnylam Pharmaceuticals seeks a Senior Manager, Regulatory Sciences Compliance to lead the regulatory sciences compliance framework and provide oversight across Regulatory Strategy, Operations, Labeling, Global Safety Operations, Medical Safety, and Risk Management. Hybrid role, primarily located in Cambridge, MA, USA.

You will drive KPIs, manage deviations and CAPAs, and coordinate QA interfaces and inspections while partnering with cross-functional teams to ensure GMP/GDP alignment and