Senior Regulatory Affairs Associate

Regulatory Professionals ,
Gloucester, Gloucestershire

Overview

Senior Regulatory Affairs Associate 12 Month Contract Cambridgeshire and London Based Oncology Focus Regulatory Professionals are working with a leading biotechnology firm, who are looking for a Senior Regulatory Affairs Associate, on a 12-month contract. With this opportunity you can work out of either of their, Cambridge or London, offices under the supervision of a Regional Regulatory Lead within the Oncology team. Job Responsibilities Include; Core CTA/IMPD development and submission, support for pre-MAA filing, regulatory authority meeting preparations) Provide and maintain CTA/MA documentation support (e.g. variations, substantial amendments, PDCO annual reports) Prepare regulatory packages and cross-reference letters to support investigator initiated studies Actively support regulatory compliance Support the development and execution of GRT goals Candidate Requirements include; Must be eligible to live and work in the UK Life Sciences degree or equivalent Strong communication skills - written and oral A minimum of 2 year Regulatory experience preferably within clinical trial applications If this position is of interest to yourself please call Ben at Regulatory Professionals on 0118 952 2797 or alternatively send your CV to This job was originally posted as www.totaljobs.com/job/89689832