Regulatory Affairs Executive- Wrexham- Hybrid working. I'm currently partnering with a well-established pharmaceutical manufacturer based in Wrexham, known for producing generics and sterile products for global markets. This is a fantastic opportunity for a Regulatory Affairs professional with 2-3 years of experience to take the next step in their career and grow within a reputable, international business. Key responsibilities for the Regulatory Affairs Executive Determine and communicate submission requirements; assess documentation for regulatory acceptability Prepare and compile documentation for marketing authorisations, renewals, eCTD baselines, and variations Ensure dossiers are clear, consistent, and complete, with all open questions resolved Respond to internal and external regulatory information requests Commission and review artwork for submission suitability, regulatory compliance, and brand alignment Coordinate and prepare submission packages for regulatory agencies Support development of variation submission strategies Liaise and negotiate with regulatory authorities to secure favourable outcomes Collaborate with third-party companies, including contract manufacturers Draft Summary of Product Characteristics (SmPCs) and Patient Information Leaflets (PILs) Operate and improve administrative procedures within the Regulatory Affairs department Publish electronic submissions using dedicated software Comply with and ...