Remote EU Senior Regulatory Affairs Manager — CMC & Vaccines

Parexel; Uxbridge; Remote; GBP 90,000 - 130,000; Full time

Job summary

Parexel is seeking a Senior Regulatory Affairs Manager/Consultant with 10+ years in regulatory affairs and CMC expertise. The role supports diverse projects on a global pharmaceutical backdrop, handling client relationships and regulatory strategies across Europe.

This client-dedicated project role is home or office based in various European locations, with emphasis on independent execution and cross-functional collaboration.

Qualifications

• 10+ years of experience in regulatory affairs.
• Knowledge of CMC writing and variations strategy.
• Working knowledge of vaccines or biological processes.
• Experience with regulatory agencies (e.g., 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 English written and spoken; additional languages are a plus.

Responsibilities

• Write CMC sections and scientific rationales for regulatory submissions and responses.
• Develop and implement variations strategies based on 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 proposal preparation.

Skills

CMC writing

Regulatory strategy

Vaccine/biologics knowledge

Regulatory agencies

EU guidelines

Project management

Client relationship management

Independent working

Team collaboration

English fluent

Job description

Parexel is seeking a Senior Regulatory Affairs Manager/Consultant with 10+ years in regulatory affairs and CMC expertise. The role supports diverse projects on a global pharmaceutical backdrop, handling client relationships and regulatory strategies across Europe.

This client-dedicated project role is home or office based in various European locations, with emphasis on independent execution and cross-functional collaboration.