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Are you ready to make your mark in the healthcare industry using your ingenuity and technical expertise? At Parexel, there's no limit to what you can accomplish. We work with the top 50 global pharmaceutical companies, the top global biotech companies, and hundreds of small and emerging companies. We've supported the development of some of the most important treatments of our time, including nearly all of the 50 top selling drugs currently on the market. Join us and you'll make a profound difference in millions of lives. With a role in our Information Technology group, you'll work with cutting-edge technology on internal and client-facing projects. Collaborating with people from all over the world and touching everything from enterprise systems and clinical applications to infrastructure and networking, you'll keep our data safe and confidential. You'll have the chance to develop your skills and pursue advancement opportunities that include managerial and technical tracks. If you have stellar coding and design experience and a passion to learn more about healthcare, Parexel invites you to discover our rewarding opportunities in Enterprise Architecture, Software Development, Project Management and Business Analysis, and more. In a global clinical trial environment, business-focused applications, connectivity, and data security are critical to a trial's outcome. Find out how you can be an invaluable part of our success story.
Senior Regulatory Affairs Manager - CMC bio/vax (various European locations - home or office based)
Job ID R0000047663 , United KingdomWe 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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