EU Regulatory Strategy Lead – CNS Programs

Alnylam Pharmaceuticals, Inc.; Maidenhead; Hybrid; GBP 120,000 - 160,000; Full time

Job summary

Alnylam Pharmaceuticals, Inc. is seeking an Associate Director of Regulatory Affairs Strategy to act as the EU Regional Lead for mid/late-stage CNS programs and possibly Regulatory Program Lead for early programs.

You will guide EU regulatory strategy, coordinate EMA submissions, and collaborate with Global Regulatory Team across product development and trials. The role requires strong regulatory intelligence, submission oversight, and strategic planning to align with Alnylam Core Values.

Qualifications

• Excellent written and verbal communication skills; ability to negotiate and influence.
• Solid understanding of EU regulations and guidance; ability to interpret guidelines for submissions.
• Experience with regulatory filings including CTAs, MAA filings, variations, and safety reporting.

Responsibilities

• Serve as EU Regional Lead for assigned programs; potentially Regulatory Program Lead for early programs.
• Lead EU regulatory strategy and coordinate regulatory submissions for EMA; prepare briefing documents and applications.
• Develop detailed regulatory strategy and project plans; align with Global Regulatory Team and cross-functional partners.

Skills

Regulatory strategy

Regulatory submissions

Communication skills

Project management

Team collaboration

Technical systems

Strategic thinking

Education

Bachelor's degree

Advanced degree

Job description

Alnylam Pharmaceuticals, Inc. is seeking an Associate Director of Regulatory Affairs Strategy to act as the EU Regional Lead for mid/late-stage CNS programs and possibly Regulatory Program Lead for early programs.

You will guide EU regulatory strategy, coordinate EMA submissions, and collaborate with Global Regulatory Team across product development and trials. The role requires strong regulatory intelligence, submission oversight, and strategic planning to align with Alnylam Core Values.