Senior Regulatory Affairs Specialist- CMC Biologics
Today, 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.
We are currently looking for an experienced Senior Regulatory Affairs Specialist- CMC Biologics to join our Centre of Excellence for biopharmaceutical process development and small-scale GMP manufacturing in Slough, UK.
The Senior Regulatory Affairs Specialist- CMC Biologics will support CMC project activities for customers. Working collaboratively with company personnel to co-ordinate the regulatory CMC activities for early phase INDs/IMPDs and license applications. You will provide regulatory support and advice for the Slough site and support in site specific regulatory documents.
- Prepare and support clinical trial and product license applications for customers (for mammalian products).
- 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 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 LPB RA team.
- Perform other duties as assigned.
- Life Sciences graduate, educated to degree level or above (eg: biology, chemistry), preferred area of study: Life Sciences (e.g. chemistry, biology, biochemistry, pharmacy)
- Hands on pharmaceutical industry experience in Regulatory Affairs department
- Experience in preparing and authoring CMC sections for early phase applications and license applications
- Good understanding of regulatory requirements
- Demonstrated skills managing project timelines
Every day, 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.