Director, Regulatory Technology

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 Technology & Medical Writing Systems will play a critical role in shaping and executing the technology strategy supporting Regulatory Affairs, Regulatory Operations, and Medical Writing. This role serves as the primary business technology functional leader for these teams, ensuring that platforms, data, content capabilities, and digital workflows enable compliant, efficient, inspection-ready, and insight-driven regulatory and medical writing operations across the product lifecycle.

Success in this role requires strong development-domain business acumen, technical fluency across regulated platforms, and the ability to translate functional priorities into a practical technology roadmap. The leader will be expected to connect strategy to execution—partnering with business stakeholders, enterprise Technology, Data, Quality, Security, and vendor teams to deliver scalable, compliant, and user-centered solutions.

Rather than serving as a single-system product owner, this role provides functional technology leadership across the broader Regulatory and Medical Writing capability landscape. The Director will shape priorities, connect process and data needs across platforms, and work through dedicated product owners, application teams, vendors, and enterprise technology partners to ensure solutions advance the end-to-end business strategy.

Key Responsibilities

• Serve as the primary business technology functional leader and strategic partner for Regulatory Affairs, Regulatory Operations, and Medical Writing, building trusted relationships with functional leadership to understand objectives, priorities, pain points, and technology needs.
• Define and maintain the technology roadmap for Regulatory and Medical Writing capabilities, translating business strategy into prioritized programs, platform investments, process improvements, and data/content enablement initiatives.
• Lead the functional direction, prioritization, and continuous improvement of technology capabilities supporting regulatory information management, submission planning and publishing, document/content authoring, structured content, medical writing workflows, and related integrations.
• Own the technology partnership model for the supported functions, including demand shaping, prioritization, business case development, solution alignment, delivery oversight, adoption planning, operational readiness, and value realization.
• Drive adoption of the technology operating model within Regulatory and Medical Writing, emphasizing clear governance, functional ownership of process and outcomes, fit-for-purpose vendor leverage, and close alignment with platform teams, enterprise Technology, Data, Quality, and Security.
• Establish and enforce technology governance, standards, and best practices, including data privacy, security, validation, records management, inspection readiness, and compliance with global regulatory requirements.
• Partner with product owners and application teams to ensure platform backlogs, release priorities, configuration decisions, validation plans, and support models reflect Regulatory and Medical Writing business needs without duplicating system-level product ownership.

Regulatory Data, Content & Architecture Leadership

• Provide technology leadership in the design and evolution of regulatory and medical writing data, content, and platform architectures, including RIM data, submission metadata, document management, structured authoring, review/approval workflows, and content reuse.
• Partner with Data and Analytics teams to enable cross-system reporting, traceability, and analytics across regulatory, clinical, and document/content domains, while maintaining clear data ownership, security, and compliance boundaries.
• Enable technology capabilities that support regulatory intelligence, submission planning, labeling/content dependencies, inspection readiness, lifecycle management, authoring efficiency, and medical writing quality.
• Assess emerging digital and AI-enabled capabilities for regulatory and medical writing processes, balancing innovation with quality, validation, governance, and responsible use expectations.
• Translate complex technical, regulatory, and compliance considerations into clear guidance, decisions, and tradeoffs for functional leadership and operational teams.

Cross‑Functional & Lifecycle Collaboration

• Collaborate closely with Clinical Development, Clinical Operations, Biometrics, Quality, Medical Affairs, Commercial, and enterprise Technology teams to ensure Regulatory and Medical Writing systems integrate effectively across the product lifecycle.
• Support global regulatory operations and medical writing delivery by enabling technology solutions that scale across regions, health authorities, programs, document types, and submission milestones.
• Partner with Quality, Security, Privacy, Records Management, and Validation teams to ensure technology solutions meet internal procedures, external regulatory expectations, and inspection readiness standards.

Vendor, Platform & Operational Leadership

• Collaborate with external vendors, product owners, application support teams, and enterprise technology partners to deliver implementations, integrations, enhancements, and operational improvements for Regulatory Affairs, Regulatory Operations, and Medical Writing.
• Guide delivery and support partners with sufficient functional and technical depth to challenge solution designs, assess architecture and data tradeoffs, and ensure delivered capabilities meet compliance, scalability, usability, and integration standards.
• Proactively identify functional, process, data, and technical gaps in Regulatory and Medical Writing systems and recommend pragmatic improvements.
• Use root cause analysis and troubleshooting skills to resolve complex functional and technical issues impacting regulatory submissions, document workflows, content quality, or operational delivery.
• Act as an escalation point for critical technology issues impacting Regulatory Affairs, Regulatory Operations, and Medical Writing operations.

Qualifications

• 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 shaping technology strategy and capability roadmaps in GxP-regulated life sciences environments, ideally across platforms, processes, data, and content workflows.
• Demonstrated ability to operate at both strategic and technical depth, including evaluating architecture options, validation approaches, and data integration strategies.
• Experience supporting Regulatory Affairs, Regulatory Operations, Medical Writing, or adjacent development functions preferred.
• Familiarity with regulatory systems and content platforms, such as Veeva Regulatory, RIM, electronic document management, submission planning/publishing, structured content authoring, workflow automation, integration services, and enterprise data ecosystems.
• 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.

 

About Alnylam

We are the pioneer in RNA interference (RNAi) therapeutics – a revolutionary approach to treating diseases which “silences” the genes that cause or contribute to them. Founded based on Nobel Prize-winning science, our work over more than two decades has yielded the critical breakthroughs and advancements that have made the field of RNAi therapeutics possible. Guided by core values like fierce innovation, purposeful urgency, and passion for excellence, our open and inclusive culture drives everything we do. We are proud to be globally recognized as a top employer, where people feel valued and breakthrough thinking flourishes.

About Alnylam: Alnylam Pharmaceuticals (Nasdaq: ALNY) has led the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of people afflicted with rare and more prevalent diseases. Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful, clinically validated approach to treating diseases at their genetic source by “interfering” with mRNA that cause or contribute to disease. Since our founding in 2002, Alnylam has led the RNAi Revolution and continues to turn scientific possibility into reality.

Our culture: Our people-first culture is guided by our core values: fiercely innovative, open culture, purposeful urgency, passion for excellence, and commitment to people, and these values influence how we work and the business decisions we make. Thanks to feedback from our employees over the years, we’ve been fortunate to be named a top employer around the world. Alnylam is extremely proud to have been recognized as one of Science Magazine’s Top Biopharma Employers, one of America's Most Responsible Companies for 2024 by Newsweek, a Fast Company Best Workplace for Innovators, and a Great Place to Work in Canada, France, Italy, Spain, Switzerland, and UK – among others.

At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. We are dedicated to building an environment where employees can feel that they belong, can bring their authentic selves to work, and achieve to their full potential. By empowering employees to embrace their unique differences at work, our business grows stronger with advanced and original thinking, allowing us to bring groundbreaking medicines to patients.

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