Regulatory Affairs Senior Manager - EU & Global Submissions

Alnylampharmaceuticals; Maidenhead; Hybrid; GBP 90,000 - 120,000; Full time

Job summary

Alnylam Pharmaceuticals is seeking a Senior Manager, Regulatory Affairs to drive planning and delivery of regulatory submissions across EU and international health authorities. The role works with global leads and cross-functional teams to support product development and registrations, including preparation of key regulatory documents and lifecycle submissions.

You will contribute to regulatory strategy, coordinate interactions with regulatory authorities, and mentor teams on submission

Qualifications

• Bachelor's degree in a scientific or regulatory field, 4+ years in regulatory affairs
• Excellent written and verbal communication and negotiation skills
• Experience with regulatory filings and e-submissions (CTAs, DSURs, variations)
• Strong organizational and cross-functional collaboration skills

Responsibilities

• Lead planning and delivery of regulatory submissions across EU/global teams
• Develop regulatory project plans and support activities for product portfolios
• Represent EU regulatory in multidisciplinary teams and provide regulatory advice
• Coordinate responses to authority questions within deadlines
• Maintain regulatory files and ensure compliance with SOPs

Skills

Regulatory strategy

Regulatory submissions

Cross-functional teamwork

Project management

Writing/editing

Quality/compliance

Education

Bachelor's degree in related field

Advanced degree preferred

Tools

Electronic submissions (CTAs, DSURs)

Job description

Alnylam Pharmaceuticals is seeking a Senior Manager, Regulatory Affairs to drive planning and delivery of regulatory submissions across EU and international health authorities. The role works with global leads and cross-functional teams to support product development and registrations, including preparation of key regulatory documents and lifecycle submissions.

You will contribute to regulatory strategy, coordinate interactions with regulatory authorities, and mentor teams on submission