Senior Manager, Regulatory Sciences Compliance

Overview

The Senior Manager, Regulatory Sciences Compliance (QSC) develops and maintains the compliance framework for in-scope Regulatory Sciences activities across Regulatory Strategy, Regulatory Operations, Labeling, Global Safety Operations, Medical Safety and Risk Management, and International functions. The role partners cross-functionally with process owners to translate regulatory obligations and operational risks into meaningful compliance indicators, governance, and sustainable improvement actions.

The role supports compliance throughout the product lifecycle from Good Clinical Practice (GCP) through Good Pharmacovigilance Practice (GVP), with emphasis on business-owned Regulatory Sciences processes, regulatory commitments, submission and reporting performance, and inspection readiness.

Activities governed by Good Manufacturing Practice (GMP) or Good Distribution Practice (GDP), including CMC regulatory compliance, manufacturing quality oversight, batch disposition, supplier quality, and GMP audit execution, are outside the scope of this role.

The role leads the design, implementation, and ongoing evaluation of Regulatory Sciences compliance KPIs and metrics, including determining which indicators are relevant, establishing consistent definitions and data sources, monitoring performance and trends, and partnering with accountable owners to define and track actions when thresholds or expectations are not met.

The position also provides compliance oversight and coordination for deviations and CAPAs, serves as a key business-side liaison with Quality Assurance, and drives proactive risk management, governance, and continuous improvement across the regulatory activities in scope.

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

Key Responsibilities

Compliance Oversight for Regulatory Sciences

• Support and augment the QSC compliance framework as it applies to in-scope Regulatory Sciences activities, ensuring alignment with applicable regulatory requirements, commitments, internal procedures, and Quality Management System requirements.
• Provide business-side compliance governance across relevant in-scope Regulatory Sciences subfunctions
• Identify compliance risks and partner with Regulatory Sciences process owners and QSC leadership to prioritize, implement, and monitor proportionate mitigation actions.
• Build effective cross-functional partnerships across Regulatory Sciences, Safety and Risk Management, Quality Assurance, data and technology teams, and adjacent GxP compliance functions to align expectations, resolve issues, and share relevant practices.

KPI Monitoring & Compliance Metrics

• Partner with Regulatory Sciences stakeholders to identify and define relevant KPIs, key risk indicators, and compliance metrics that reflect regulatory obligations, operational performance, data quality, timeliness, and emerging risk.
• Establish and maintain metric definitions, calculation logic, data sources, ownership, thresholds, reporting cadence, and escalation criteria to support consistent and reliable monitoring.
• Develop and maintain compliance reports and dashboards that provide actionable insights for process owners and Regulatory Sciences leadership.
• Assess metric performance and data quality, distinguish isolated events from recurring or systemic trends, and identify areas requiring further review, remediation, or escalation.
• Partner with accountable process owners to define action plans, track completion, and evaluate whether actions have improved performance or reduced compliance risk.
• Periodically evaluate the continued relevance and effectiveness of the metric portfolio and recommend additions, retirement, or refinement as processes, risks, and regulatory expectations evolve.

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

• Lead cross-functional continuous improvement initiatives informed by compliance data, recurring trends, process risk, and inspection or audit learnings to strengthen Regulatory Sciences operational compliance.
• Facilitate governance discussions that convert metric and risk insights into clear decisions, accountable actions, target dates, and documented follow-through.

Qualifications

• Bachelor’s degree in Regulatory Affairs, Life Sciences, Pharmacy, or related field and/or a licensed healthcare professional (advanced degree preferred)
• Direct experience in Regulatory Sciences operations or compliance is required. A background focused primarily on GMP/CMC regulatory activities or traditional Quality Assurance activities, without experience in the in-scope Regulatory Sciences processes, will not align with the core needs of this role.
• Minimum of 4 years of experience in the pharmaceutical or biotechnology industry, including substantial experience supporting Regulatory Affairs, Regulatory Operations, pharmacovigilance, or Regulatory Sciences compliance activities.
• Strong knowledge of global regulatory frameworks, Regulatory Affairs and Regulatory Operations processes, pharmacovigilance interfaces, and Quality Management System expectations relevant to the activities in scope.
• Demonstrated experience designing or improving regulatory-related KPI and compliance metric frameworks, including metric selection, definitions, data sourcing, thresholds, trend analysis, governance reporting, and action tracking.
• Experience using data, dashboards, and trend analysis to identify compliance risk and drive measurable cross-functional improvement; experience supporting regulatory inspections and internal audits is strongly preferred.
• Experience working within a Quality Management System environment and supporting cross-functional compliance governance from a Regulatory Sciences or business-process perspective.
• Demonstrated ability to influence and partner with functional process owners, data owners, technology teams, and Quality Assurance while maintaining objective compliance oversight.
• Strong facilitation, leadership, and project management skills, with the ability to align diverse stakeholders, clarify ownership, and convert complex compliance information into practical decisions and actions.
• Excellent written and verbal communication skills, including the ability to communicate complex regulatory, risk, and performance information clearly to both technical and leadership audiences.
• Ability to work independently, prioritize effectively, and operate successfully in a highly matrixed, cross-functional environment.
• Proficiency with reporting and visualization tools and the ability to work with structured data are strongly preferred.

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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.

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