Regulatory Affairs Executive

Job Purpose

•    To maintain product licences held by the Company.  
•    To ensure that new licence applications are submitted appropriately and that licences are kept up to date by appropriate maintenance applications with the relevant Regulatory Authorities.  
•    Ensure that all associated submission applications are performed effectively and efficiently.  
•    To provide support and deputise for the Senior Regulatory Executive as and when required.

Profile

The role requires:
•    Life Sciences degree 
•    Experience of working in a pharmaceutical regulatory/licensing environment.
•    Working knowledge of Regulatory Affairs legislative procedures and processes 
•    Good communication and interpersonal skills
•    Ability to work well in a team environment
•    Good planning and organisation skills
•    High-level attention to detail and accuracy
•    Strong IT skills, including MS Excel, Word and Powerpoint
•    High standard of literacy and written communication.

Responsibilities

•    Preparation and submission of applications for new Marketing Authorisations, renewal, variation and change of ownership to the Regulatory Authorities in a timely and accurate manner, taking into consideration commercial needs
•    Preparation and publishing of regulatory submissions within eCTD format and update of the Regulatory Information Management System (RIMS)
•    Prepare responses to questions issued by the Regulatory Authorities
•    Follow up with Regulatory Authorities on submissions and regulatory issues
•    Request, review and submit all PSURs as required
•    Direct negotiations and liaisons with 3rd party companies and other departments of the company concerning submission applications
•    Writing, reviewing and advising on SmPCs and packaging
•    Keep up to date with the latest guidelines and legislation (including monitoring regulatory websites), advising colleagues on implications of any changes.
•    File maintenance and organisation
•    Maintain smooth running of the regulatory department and the licensing update processes
•    Where appropriate, draft SOPs/Working Instructions for review by the Head of Regulatory & Pharmacovigilance prior to final approval and issue.
•    To create, amend and review Food Supplement packaging artwork in line with food supplement regulations and guidelines.  To submit Food Supplement artworks to external regulatory and copy clearance agencies for review.
•    To perform other duties as required
•    In line with annual objectives, contribute and support the UK Affiliate in its pursuit to become more sustainable.