6 months ago
Job title: Regulatory Affairs Officer
A global pharmaceutical business based in London are seeking a Regulatory Affairs Officer to join their growing team. This role requires someone with experience working on development projects across a variety of therapy areas with a focus on EU regions.
- Support planning, preparation, coordination, review, Quality Control, and submission of regulatory submissions for EU (and any other responsible countries/territories) e.g., Clinical Trials Authorisations, Orphan Drug Designations, Paediatric Investigations Plans etc.
- Lead and support for maintenance activities for marketed product licenses in UK and Ireland
- Provide on-going local regulatory intelligence related to specific project and therapy area/indication
- Ensure compliance with the quality management system
- Strong EU experience as well as knowledge of EU health authorities.
- Experience around clinical trial activities.
- UK/IE post marketing experience would be beneficial.
- Strong communicator with the ability to liaise cross functionally.
Salary and benefits:
A competitive salary and benefits package is on offer for this role.
To apply for this position or hear further details then please contact Freddie Hill via Freddie.firstname.lastname@example.org