Description
My client is currently searching for an experienced UK & Ireland focussed regulatory specialist to join their team on an initial 12 month contract basis.
Responsibilities:
*Support regulatory activities for National and/or European procedures (Decentralised, Mutual Recognition) as appropriate.
*Develop and support regulatory strategies (local and regional) in line with business plan.
*Complete regulatory activities for a defined number of products to ensure all regulatory obligations and business objectives are met.
*Prepares and compiles regulatory submissions (Marketing Authorisations, Reclassifications etc.), responses to Regulatory Agency (RA) questions and other correspondence in accordance with EU regulations and guidelines.
*Sign off of packaging material, leaflets, SmPCs and advertising material to ensure regulatory compliance for submissions via Zinc, COCOON, Starfish systems etc.
*Ensure Marketing Authorisations are maintained and renewed.
*Inform the Regulatory Agency/Department of Health (as appropriate) of product discontinuations and licence cancellations.
Experience Required:
*Life sciences or chemistry graduate to honours level or equivalent.
*Works independently to plan, conduct, and manage regulatory submissions and multiple projects to meet department and company objectives.
*Work with minimal supervision to determine and develop approaches to solutions with technical guidance on a variety of problems of moderate scope and complexity.
*May mentor Regulatory Executives and provide day to day support.
*Project management, understanding of regulatory environment, interaction with the Regulatory Authorities, commercial / strategic awareness, implement regulatory strategy, managing and maintaining Marketing Authorisations.
For further details about this role, or other vacancies within Regulatory Affairs, please contact Tim Barratt on +44(0)1727 817 626 or email tbarratt@keypeople.co.uk
