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.

Responsibilities:

• 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.

Requirements:

• 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 matt.thomas@pharma-partners.co.uk