Senior Regulatory Affairs Manager
3 months ago
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
#LI-REMOTE
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