Senior Regulatory Affairs Manager (CMC) – Remote Vaccine

Parexel; United Kingdom; Remote; GBP 90,000 - 120,000; Full time

Job summary

Parexel is seeking a Senior Regulatory Affairs Manager/Consultant with 10+ years of regulatory affairs experience, including CMC writing and variations strategy, to lead regulatory submissions and strategic advice for diverse global pharmaceutical projects.

This client-dedicated role can be home or office based across Europe. You will manage client relationships, coordinate CMC activities, and contribute to regulatory strategies while ensuring high-quality deliverables and timely responses.

Qualifications

• 10+ years of regulatory affairs experience.
• CMC writing and variations strategy expertise.
• Experience with vaccines or biological processes.
• Experience with regulatory agencies (FDA, EMA, MHRA).
• Understanding of EU guidelines (Variation, ICH, EMA).
• Excellent project management and organizational skills.
• Strong communication and client management experience.
• Ability to work independently and as part of a team.
• Fluent in written and spoken English; additional languages a plus.

Responsibilities

• Write CMC sections and rationales for submissions.
• Develop variations strategies per EU guidelines.
• Coordinate CMC activities across multiple projects.
• Liaise with global affiliates and manufacturing sites.
• Provide project leadership and management.
• Ensure client satisfaction and project quality.
• Identify new business opportunities and contribute to proposals.

Skills

Regulatory affairs

CMC writing

Variations strategy

Project management

Client management

Team collaboration

English fluency

Independent work

Job description

Parexel is seeking a Senior Regulatory Affairs Manager/Consultant with 10+ years of regulatory affairs experience, including CMC writing and variations strategy, to lead regulatory submissions and strategic advice for diverse global pharmaceutical projects.

This client-dedicated role can be home or office based across Europe. You will manage client relationships, coordinate CMC activities, and contribute to regulatory strategies while ensuring high-quality deliverables and timely responses.