Regulatory Affairs Executive
Manchester, GB
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.
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