Senior Regulatory Affairs Manager – CMC, Bio/Vax
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Job Description
Senior Regulatory Affairs Manager guiding CMC submissions, variation strategies, and regulatory responses for Parexel’s pharmaceutical clients. Coordinating global affiliates and manufacturing sites across European locations.
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
- Work on a client-dedicated project without people management responsibility
Requirements:
- 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
Benefits:
- Home or office based working arrangement
- Opportunity to work on diverse projects
- Global pharmaceutical environment
- Client-dedicated project experience
- Additional languages are a plus
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