EU Regulatory Strategy Lead for CNS Programs

Alnylampharmaceuticals; Maidenhead; On-site; GBP 110,000 - 140,000; Full time

Job summary

Alnylam Pharmaceuticals is seeking an Associate Director of Regulatory Affairs Strategy to serve as EU Regional Lead for mid/late-stage CNS programs. You will coordinate EU regulatory submissions to EMA, work with the Global Regulatory Lead, and guide regulatory strategy across product development.

The role involves leading regulatory activity on subteams, providing regulatory intelligence, and liaising with CROs and internal departments.

Qualifications

• Bachelor's degree with 6+ years in Regulatory Affairs; biotech/pharma experience preferred
• Excellent written and verbal communication; negotiation and influencing skills
• Strategic thinker able to identify issues and mitigation in drug development
• Experience with regulatory filings, including CTAs, post-marketing variations, safety reporting, paediatric plans, PRIME etc.

Responsibilities

• Lead EU regulatory strategy for assigned programs and coordinate submissions to EMA
• Represent RA on multidisciplinary product development subteams and Global Regulatory Team
• Coordinate regulatory submissions, ensure timely responses to authority questions
• Provide EU regulatory intelligence to internal stakeholders and maintain regulatory files
• Liaise with internal departments, CROs and regulatory authorities to ensure compliance

Skills

Excellent communication

Negotiation skills

Strategic thinking

Project management

Interpersonal skills

Education

Bachelor's degree

Tools

Word processing

Spreadsheets

Databases

Job description

Alnylam Pharmaceuticals is seeking an Associate Director of Regulatory Affairs Strategy to serve as EU Regional Lead for mid/late-stage CNS programs. You will coordinate EU regulatory submissions to EMA, work with the Global Regulatory Lead, and guide regulatory strategy across product development.

The role involves leading regulatory activity on subteams, providing regulatory intelligence, and liaising with CROs and internal departments.