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Senior Regulatory Affairs Manager - CMC (various locations)

United Kingdom, Remote 求人ID R0000027731 カテゴリー Regulatory / Consulting
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About this Role

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 (23S, 23P, 32S, 32P) 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

  • 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

  • Proficiency in English; additional languages are a plus

Preferred Qualifications:

  • Experience with regulatory agencies (e.g., FDA, MHRA)

  • Industry-recognized certifications or advanced degrees

  • Publication history or experience presenting at industry conferences

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