5 months ago
Job title: Senior Regulatory Affairs Associate
A CRO with offices based in London are seeking a Senior Regulatory Affairs Associate to join their global team. You will be working with local and international teams supporting clinical development across a range of therapy areas such as Oncology, Cardiology, Metabolic Disease, and Endocrinology.
- Preparation and delivery of regulatory submissions to domestic and international regulatory agencies.
- Maintain timelines for components of regulatory deliverables.
- Perform document quality control checks in accordance with established processes.
- Maintain and train on up-to-date regulatory requirements, guidance and science; and may be responsible for other projects and responsibilities as assigned.
- Bachelor's Degree in a related field; advanced degree highly preferred (M.D., Pharm.D, Ph.D.)
- Experience of the EMA Paediatric Investigation Procedure and Investigational Brochure would be an advantage.
- Good Regulatory Affairs experience in the Biotechnology, Pharmaceutical or CRO industries is essential.
- Knowledge of EU procedure, ODD and Scientific Advice.
Salary and benefits:
A competitive annual salary and benefits package is on offer.
To apply for this position or hear further details then please contact Matt Thomas via email@example.com