Senior Regulatory Affairs Specialist

3 weeks ago

Slough, United Kingdom Lonza Full time

United Kingdom, SloughToday Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

Key responsibilities:

- Write / review CMC sections
- Prepare briefing documents for agency meetings
- Attend customer meetings and project team meetings
- Devise and maintain regulatory project plans in line with best practice recommendations
- Update functional leads and maintain transparency of information across regulatory function
- Provide regulatory support and advice for external and internal customer in line with defined Regulatory plans and in response to ad-hoc questions
- Provide regulatory assessments and approvals for change controls and deviations
- Facilitate and support the development and documentation of revised regulatory processes in line with global processes within the Biologics RA team

Key requirements:

- Master or Bachelor degree in Life Sciences (e.g. Biology, Biochemistry, Pharmacy)
- Experience in preparing and authoring CMC (Chemistry, Manufacturing and Control) sections for regulatory documents through product life cycle
- Good understanding of regulatory requirements for biologicals and good practical experiences in Regulatory Affairs in a pharmaceutical environment
- Previous experience in CMO/CDMO environment is a clear advantage
- Fluent in English required
- Ability to work across a complex matrix environment
- Structured, focused and well-organized working attitude; open-minded for new ideas and suggestions; agile, highly motivated and dynamic drive

Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

**Reference: R50344**:

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