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Open nowPosted yesterday

Senior Regulatory Affairs Manager - CMC bio/vax (various European locations - home or office based)

Parexel38 open roles

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United Kingdom Harrow Remote
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Your applicationOpen nowSenior Regulatory Affairs Manager - CMC bio/vax (various European locations - home or office based)Parexel · United Kingdom Harrow Remote
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The clock on this job

Early applications get read.

13.3% of postings close within 7 days. Measured by our own scanner across the market. Parexel postings stay open a median of 13 days.

Share of postings closed within
  1. 2.1%1 day
  2. 4.6%3 days
  3. 13.3%7 days
  4. 21.3%14 days
  5. 35.7%30 days
  6. 59.1%60 days
This job: posted yesterday

Parexel median: 13 days open

The posting

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

Required 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
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