Director, Regulatory Sciences Technology

Alnylam Pharmaceuticals•Cambridge, MA

17d

About The Position

Alnylam is the world’s leading RNA interference (RNAi) company, dedicated to transforming the lives of patients through innovative medicines. As Alnylam continues to expand its global development and regulatory footprint, Regulatory Sciences supports increasing portfolio complexity, global regulatory engagement, and heightened expectations for data quality, compliance, and operational efficiency. The Director, Regulatory Sciences Technology will play a critical role in shaping and executing the technology strategy supporting Regulatory Affairs, Safety, and Medical Writing. This role serves as the primary technology leader and business partner for Regulatory Sciences, ensuring that systems, data, and digital capabilities enable compliant, efficient, and insight‑driven regulatory operations across the product lifecycle. Success in this role requires a combination of strong Regulatory Sciences business acumen and deep technical fluency across regulated platforms, data integration, and document‑centric workflows, enabling the organization to operate at global scale while meeting evolving regulatory expectations.

Requirements

Degree in Information Technology, Computer Science, Data Science, or related field, with experience in regulated life sciences environments.
Proven business analysis skills with strong analytical and problem-solving abilities.
Effective prioritization and project management skills.
Significant experience delivering and supporting GxP-regulated technology platforms in healthcare or biopharma.
Demonstrated ability to operate at both strategic and technical depth, including evaluating architecture options, validation approaches, and data integration strategies.
Strong team player with the ability to maintain effective relationships at all levels.
Ability to anticipate, understand, and address changing regulatory and business needs.
Excellent communication skills, both oral and written.
Leadership and/or supervisory experience.

Nice To Haves

Experience supporting Regulatory Affairs, Safety, Medical Writing, or adjacent development functions preferred.
Familiarity with regulatory systems (e.g., RIM, safety databases, document/submission platforms) and enterprise data ecosystems.

Responsibilities

Serve as the primary technology leader and business partner for Regulatory Sciences, building strong relationships with leadership across Regulatory Affairs, Safety, and Medical Writing to understand objectives, priorities, and technology needs.
Develop deep expertise in Regulatory Sciences business processes, proactively identifying opportunities where technology, data, and automation can improve compliance, efficiency, and submission quality.
Lead the delivery, support, and continuous improvement of Regulatory Sciences technology platforms (e.g., regulatory information management, safety systems, document and submission platforms), providing hands-on technical leadership and architectural guidance to ensure solutions are scalable, compliant, and audit-ready.
Drive adoption of the technology operating model within Regulatory Sciences, emphasizing centralized governance, in-house leadership, and close alignment with enterprise Technology, Data, and Quality teams.
Oversee the lifecycle of Regulatory Sciences technology solutions, including requirements gathering, vendor management, implementation, and ongoing support, with a focus on architecture integrity, data consistency, and inspection readiness.
Establish and enforce technology governance, standards, and best practices, including data privacy, security, validation, and compliance with global regulatory requirements.
Provide technical leadership in the design and evolution of Regulatory Sciences data and content architectures, including structured regulatory data, submission metadata, safety case data, and document management workflows.
Partner with Data and Analytics teams to enable cross-system linkage and reporting across regulatory, safety, and clinical domains, while maintaining clear data ownership and compliance boundaries.
Enable technology capabilities that support regulatory intelligence, submission planning, inspection readiness, and lifecycle management.
Translate complex technical and compliance considerations into clear guidance for Regulatory Sciences leadership and operational teams.
Collaborate closely with Clinical, Medical Affairs, Quality, and Commercial Technology teams to ensure Regulatory Sciences systems integrate effectively across the product lifecycle.
Support global regulatory operations by enabling technology solutions that scale across regions, health authorities, and submission types.
Partner with Quality, Security, and Validation teams to ensure technology solutions meet internal and external compliance expectations.
Collaborate with external vendors and internal technology teams to deliver Regulatory Sciences platform integrations and enhancements.
Support and guide Application Support teams and external partners, bringing sufficient technical depth to challenge solution designs, assess architectural and data tradeoffs, and ensure vendor-delivered capabilities meet Alnylam’s compliance, scalability, and integration standards.
Proactively identify functional and technical gaps in Regulatory Sciences systems and recommend improvements.
Use root cause analysis and troubleshooting skills to resolve complex functional and technical issues.
Act as an escalation point for critical technology issues impacting Regulatory Sciences operations.

Benefits

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.

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