Regulatory Affairs Officer - Pharmaceuticals

Regulatory Affairs Officer - Pharmaceuticals - £30k-£40k

I am currently recruiting for a Regulatory Affairs Officer for a multinational Pharmaceutical manufacturing company in West Yorkshire to manage their new and existing portfolios of generic and branded pharmaceutical products.

As a regulatory Affairs Officer you will have the opportunity to work on new and existing licences in multiple global markets, liaising with various regulators, managing MAA and managing regulatory dossiers through the full product life cycle.

Key Responsibilities

• Act as the regulatory lead on NPD and maintenance activities for licensed generic and branded pharmaceutical products
• Support new MAAs; reviewing, compiling and submitting dossiers
• Manage existing licence portfolios including post-approval variations
• Act as company representative during meetings with industry regulators; MHRA, BGMA, PAGB etc

Requirements

• Prior experience in Pharmaceutical Regulatory Affairs is essential including dossier gap analysis and life-cycle maintenance
• Specific experience with MHRA requirements are preferred
• Prior experience with eCTD dossier storage/gap analysis along with CMC/CTD requirements

This Regulatory Affairs Officer position is an urgent requirement so please apply now