Senior Regulatory Affairs Manager
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In this Senior Regulatory Affairs role at Parexel, you will shape regulatory strategies for complex products, focusing on CMC writing and variations. You will work across global projects, coordinating activities with affiliates and manufacturing sites to deliver compliant submissions. You’ll manage client relationships, drive project quality, and identify new business opportunities in a fast-paced regulatory environment. This role offers remote or hybrid work across Europe and presents an opportunity to contribute to therapies that benefit patients worldwide. You will be part of a mission-driven team that transforms clinical development into tangible patient impact.
Responsabilità- 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
- 10+ years of experience in regulatory affairs
- Extensive knowledge of CMC writing and variations strategy
- Working knowledge of vaccines or biological processes
- Experience with regulatory agencies (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
- strong communication
- client management
- independence and teamwork
- CMC writing
- variations strategy
- regulatory submissions
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