Senior Regulatory Affairs Lead – EU & Global Strategy

Alnylam Pharmaceuticals; Maidenhead; On-site; GBP 90,000 - 120,000; Full time

Job summary

Alnylam Pharmaceuticals (Nasdaq: ALNY) seeks a Senior Manager, Regulatory Affairs to partner with EU and global regulatory leads and cross-functional teams to plan and deliver regulatory submissions across the product life cycle.

You will develop regulatory strategies, author or supervise submissions, coordinate paper and electronic filings, monitor EU requirements, and share regulatory intelligence with internal teams.

Qualifications

• Bachelor's degree with 4+ years in Regulatory Affairs strategy in biotech/pharma; advanced degree preferred.
• Excellent written and verbal communication, including negotiation and influencing skills.
• Strong understanding of regulations; ability to interpret guidelines and think strategically.
• Experience with regulatory filings, including CTAs, DSURs, post-marketing variations, paediatric plans, ODD.
• Excellent organizational and project management skills; able to prioritize multiple projects.

Responsibilities

• Lead planning, preparation and delivery of regulatory submissions throughout the product life cycle.
• Develop detailed regulatory project plans and support activities for a portfolio of products.
• Serve as a member of the Global Regulatory Team and provide EU regulatory advice.
• Coordinate responses to regulatory questions with deadlines.
• Provide EU regulatory intelligence to internal stakeholders.

Skills

Regulatory strategy

Regulatory filings

Project management

Cross-functional collaboration

CTAs

DSURs

Negotiation

Regulatory intelligence

Guidelines interpretation

Education

Bachelor's degree in Regulatory Affairs

Advanced scientific degree preferred

Tools

eCTD submissions

Job description

Alnylam Pharmaceuticals (Nasdaq: ALNY) seeks a Senior Manager, Regulatory Affairs to partner with EU and global regulatory leads and cross-functional teams to plan and deliver regulatory submissions across the product life cycle.

You will develop regulatory strategies, author or supervise submissions, coordinate paper and electronic filings, monitor EU requirements, and share regulatory intelligence with internal teams.