Senior Manager, Regulatory Sciences Compliance

Senior Manager, Regulatory Sciences Compliance

Overview

The Senior Manager, Regulatory Sciences Compliance is responsible for developing and maintaining the Regulatory Sciences compliance framework and providing oversight of compliance-related activities across Regulatory Strategy, Regulatory Operations, Labeling, Global Safety Operations, Medical Safety and Risk Management, and International functions.

The role supports compliance throughout the product lifecycle from Good Clinical Practice (GCP) through Good Pharmacovigilance Practice (GVP), ensuring alignment with internal procedures, regulatory requirements, and inspection readiness standards. Activities governed by Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) are outside the scope of this role.

The role supports the development and monitoring of Regulatory Sciences compliance metrics,

provides compliance oversight and coordination of deviationsand CAPAs, and serves as a key liaison with Quality Assurance. The position drives proactive risk management, governance, and continuous improvement to maintain sustainable inspection readiness across regulatory activities in scope.

This position is hybrid and will be primarily located in Cambridge, MA, USA.

Key Responsibilities

Compliance Oversight for Regulatory Science

• Support and augment the QSC compliance framework as it applies to Regulatory Sciences activities, ensuring alignment with applicable regulatory requirements and internal Quality Management System procedures.
• Provide compliance governance across relevant Regulatory Sciences subfunctions.
• Identify compliance risks and implement mitigation strategies in partnership with Regulatory Sciences process owners and QSC leadership.
• Collaborate with quality and compliance stakeholders across adjacent GxP functions to promote alignment, consistency, and sharing of compliance best practices.

KPI Monitoring & Compliance Metrics

• Partner with Regulatory Sciences stakeholders to define, maintain, and monitor key performance indicators (KPIs) and compliance metrics for Regulatory Sciences activities
• Develop and maintain compliance reports and/or dashboards and periodic reporting for Regulatory Sciences leadership.

• Analyze compliance trends and identify systemic issues requiring remediation or escalation.

Deviation, CAPA, and Issue Management Support

• Support oversight and management of deviations, CAPAs, and quality issues related to Regulatory Sciences activities
• Facilitate root cause analysis, CAPA development, implementation tracking, and timely closure of quality events in partnership with accountable Regulatory Sciences process owners.

Quality Assurance Interface

• Support internal audits and regulatory inspections impacting Regulatory Sciences activities.

• Coordinate responses to audit observations and inspection findings related to Regulatory Sciences activities in collaboration accountable owners QA partners.

• Ensure appropriate documentation and evidence are maintained to support inspection readiness.

Inspection Readiness Support

• Support inspection readiness initiatives related to Regulatory Sciences activities
• Conduct periodic readiness assessments and support remediation planning where gaps are identified.

• Ensure documentation and records meet inspection expectations.

Governance & Process Improvement

• Drive continuous improvement initiatives to strengthen Regulatory Sciences operational compliance.

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

#LI-AB1 #LI-Hybrid

U.S. Pay Range

$135,400.00 - $183,200.00

The pay range reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on a number of factors including, but not limited to, 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).

Alnylam’s robust Total Rewards package is designed to support your overall health and well-being. We offer comprehensive benefits including medical, dental, and vision coverage, life and disability insurance, a lifestyle reimbursement program, flexible spending and health savings accounts and a 401(k)with a generous company match. Eligible employees enjoy paid time off, wellness days, holidays, and two company-wide recharge breaks. We also offer generous family resources and leave. Our commitment to your well-being reflects our belief that caring for our people fuels the impact we create together.

Learn more about these and additional benefits offered by Alnylam by visiting the Benefits section of the Careers website: https://www.alnylam.com/careers

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.