Senior Regulatory Affairs Manager - CMC bio/vax (various European locations - ho

Description

When our values align, there's no limit to what we can achieve.

At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

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.

Key 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

Requirements

• 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