Senior Regulatory Affairs Manager - CMC bio/vax (various European locations - home or office based)
United Kingdom, Remote Additional Locations: Croatia, Remote; Croatia, Zagreb; Hungary, Budapest; Hungary, Remote; Ireland, Dublin; Ireland, Remote; Italy, Milan; Italy, Remote; Poland, Remote; Poland, Warsaw; Romania, Bucharest; Romania, Remote; Serbia, Belgrade; Serbia, Remote; Spain, Madrid; Spain, Remote; United Kingdom, London 职位编号 R0000047663 类别 Regulatory / Consulting关于这个职位
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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