Sr. Manager, Regulatory Affairs

Overview

As Senior Manager, Regulatory Affairs at Alnylam, you will drive EU and global regulatory submissions for RNAi therapeutics, collaborating with EU/regulatory leads and cross-functional teams to shape strategy and submissions across product lifecycles. You’ll coordinate paperwork, timelines, and regulatory intelligence, supporting trial development, pediatric and designation pathways, and market applications. This role blends strategic planning with hands-on documentation and stakeholder liaison to enable timely approvals. You will contribute to an innovative, people-first culture and connect regulatory insight to product success.

Responsibilities

• Lead planning, preparation and delivery of simple and complex regulatory submissions across product lifecycles
• Prepare and coordinate regulatory forms, CTAs responses, modifications, and HA meeting documents
• Support Pediatric Plans, Orphan Designation, Expedited Pathways (e.g., PRIME), and Marketing Applications and amendments
• Develop regulatory project plans and support activities for assigned product portfolios
• Represent EU regulatory perspectives within the Global Regulatory Team and cross-functional subteams
• Coordinate responses to regulatory authorities within deadlines
• Liaise with internal departments, CROs and HA program managers; maintain regulatory files
• Review regulatory documentation and suggest process/document improvements (SOPs) for compliance
• Provide EU regulatory intelligence to internal stakeholders

Key requirements

• Bachelor’s degree in a scientific field with 4+ years in Regulatory Affairs (biotech/pharma)
• Advanced scientific degree preferred
• Excellent written and verbal communication; negotiation and influencing skills
• Strong understanding of regulations and guidelines interpretation
• Strategic thinking with proactive issue identification and mitigation
• Experience with regulatory filings and electronic submissions (CTAs, DSURs, post-marketing variations, pediatric plans, ODD)
• Excellent organizational and project management abilities; capable of prioritizing multiple projects
• Team-oriented with ability to work across departments, CROs, and external consultants
• Technical skills for document preparation and submission formatting

• negotiation
• influencing
• clear communication
• regulatory submissions (electronic)
• CTA/DSUR/paediatric plan/ODD submissions
• regulatory intelligence

…