[Hiring] Senior Regulatory Affairs Manager @Parexel

Role Description

We are looking for a Senior Regulatory Affairs Manager/Consultant with 10+ years of experience in regulatory affairs, including CMC expertise. This challenging role offers the opportunity to work on diverse projects, manage client relationships, and contribute to regulatory strategies in a global pharmaceutical environment. This is a client dedicated project, without people management responsibility. The role can be home or office based in various European locations.

• 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

Qualifications

• 10+ years of experience in regulatory affairs
• Extensive knowledge of CMC writing and variations strategy
• Working knowledge of vaccines or biological processes - required
• Experience with regulatory agencies (e.g., FDA, EMA, MHRA)
• In-depth understanding of EU guidelines (Variation, ICH, EMA)
• Excellent project management and organizational skills
• Strong communication abilities 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