Associate Director, Regulatory Strategy

Overview

As Associate Director, you will lead EU regulatory strategy for CNS programs and potentially steer early pipeline programs. You will partner with Global Regulatory leads and cross-functional teams to plan submissions to the EMA, oversee EU regulatory documents, and guide HA interactions. You will shape regulatory strategy, coordinate communications, and ensure timely submissions while maintaining files and regulatory intelligence. This role sits at the nexus of strategy, execution, and cross-functional collaboration to advance Alnylam’s mission.

Responsibilities

• EU Regional Lead for assigned programs and possible Regulatory Program Lead for early programs
• Define regulatory strategy with Global Regulatory Lead and compile/submit regulatory documents for EMA, lead EU HA interactions
• Develop regulatory strategy and detailed project plans for portfolio activities
• Be a member of the Global Regulatory Team; provide strategic regulatory advice in cross-functional subteams
• Coordinate responses to regulatory questions with strict deadlines
• Act as liaison with internal departments, CROs, and regulatory program managers at health authorities
• Maintain regulatory files per internal requirements
• Review regulatory documentation and propose changes to documentation or processes (including SOPs)
• Provide EU-specific regulatory intelligence to internal stakeholders

Key requirements

• Bachelor’s degree; 6+ years in Regulatory Affairs; 8+ years in biotech/pharma preferred
• Excellent written and verbal communication; negotiation and influencing skills
• Solid understanding of regulations and interpretation of guidelines
• Strategic thinker with ability to identify issues and mitigation strategies in drug development
• Experience with regulatory filings and electronic submissions (CTAs, post-marketing variations, safety reporting, paediatric plans, PRIME)
• MAA filing and Type II variation experience preferred
• Strong organizational and project management skills; ability to prioritize multiple projects
• Team-oriented with ability to collaborate across departments, CROs, and external consultants
• Technical software skills (word processing, spreadsheets, databases, online research); submission-ready formatting

• negotiation
• influencing
• clear communication
• regulatory filings and electronic submissions (CTAs, PRIME, paediatric plans)
• MAA and Type II variation experience
• regulatory intelligence and documentation review

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