Senior Regulatory Affairs Manager — EU & Global Submissions

Alnylam Pharmaceuticals; United Kingdom; On-site; GBP 100,000 - 150,000; Full time

Job summary

Alnylam Pharmaceuticals in the United Kingdom is seeking a Senior Manager of Regulatory Affairs to lead EU and international regulatory submissions, coordinating with EU/global leads and cross-functional teams. You will influence regulatory strategy and ensure timely submissions across product life cycles.

You will author/write portions of submissions when needed and manage filing processes, staying updated on EU requirements while liaising with internal teams and CROs.

Qualifications

• Bachelor’s degree with 4+ years in Regulatory Affairs strategy in biotech/pharma.
• Excellent written and verbal communication skills, with negotiation and influencing ability.
• Strong understanding of regulations and interpretation of guidelines.
• Experience with regulatory filings and electronic submissions (CTAs, DSURs, etc.).
• Organizational and project management skills with ability to prioritize multiple projects.
• Team-oriented with ability to coordinate across departments and CROs.

Responsibilities

• Lead planning, preparation, and delivery of regulatory submissions across EU and international health agencies.
• Develop regulatory project plans and support activities for portfolio of products.
• Serve as Regulatory team member and provide EU regulatory advice in subteams.
• Coordinate responses to authorities' questions with strict deadlines.
• Liaise with internal departments, CROs, and regulatory program managers at health authorities.
• Maintain regulatory files and review technical documentation for compliance.

Skills

Excellent communication

Regulatory expertise

Strategic thinking

Regulatory submissions

Project management

Cross-functional collaboration

Education

Bachelor’s degree

Advanced scientific degree preferred

Job description

Alnylam Pharmaceuticals in the United Kingdom is seeking a Senior Manager of Regulatory Affairs to lead EU and international regulatory submissions, coordinating with EU/global leads and cross-functional teams. You will influence regulatory strategy and ensure timely submissions across product life cycles.

You will author/write portions of submissions when needed and manage filing processes, staying updated on EU requirements while liaising with internal teams and CROs.