Strategic EU/Global Regulatory Submissions Lead

United States Digital Space LLC; Maidenhead; On-site; GBP 70,000 - 110,000; Full time

Job summary

Alnylam Pharmaceuticals seeks a Senior Manager of Regulatory Affairs to drive EU and global submissions, aligning with cross-functional teams from development to registration. You will contribute to regulatory strategy and represent regulatory in product subteams, coordinating paper and electronic submissions and monitoring EU requirements.

The role requires coordinating responses to HA inquiries, maintaining regulatory files, and providing regulatory intelligence across programs.

Qualifications

• Bachelor's degree with 4+ years in Regulatory Affairs strategy in biotech/pharma.
• Excellent written and verbal communication, negotiation and influencing skills.
• Strong understanding of regulations and guideline interpretation.
• Strategic thinker who identifies issues and mitigations in drug development.
• Experience with regulatory filings and electronic submissions (CTAs, DSURs, post-marketing variations, paediatric plans, ODD).
• Organized with strong project management and ability to prioritize multiple projects.
• Able to collaborate across departments, CROs and external partners.
• Proficient with word processing, spreadsheets and submission-ready formatting.

Responsibilities

• Lead planning, preparation and delivery of regulatory submissions across product life cycle.
• Develop detailed regulatory project plans and support regulatory activities for portfolio.
• Serve on Global Regulatory Team and provide EU regulatory advice.
• Coordinate responses to regulatory questions with deadlines.
• Liaise with internal departments, CROs and regulatory program managers at health authorities.
• Maintain regulatory files to internal standards.
• Review technical regulatory documentation and suggest improvements.
• Provide EU regulatory intelligence to internal stakeholders.

Skills

Regulatory strategy

Communication

Regulatory interpretation

Strategic thinking

Regulatory submissions

Project management

Team collaboration

Regulatory intelligence

Education

Bachelor's degree (4+ years regulatory affairs)

Job description

Alnylam Pharmaceuticals seeks a Senior Manager of Regulatory Affairs to drive EU and global submissions, aligning with cross-functional teams from development to registration. You will contribute to regulatory strategy and represent regulatory in product subteams, coordinating paper and electronic submissions and monitoring EU requirements.

The role requires coordinating responses to HA inquiries, maintaining regulatory files, and providing regulatory intelligence across programs.