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X4 Group
,
London, Greater London
Freelance CMC Regulatory Writer
Overview
An exciting new opportunity with a European-based Pharmaceutical Company for an initial 12-month contract with potential for extension. This requirement is for a CMC Regulatory Writer with EMA and FDA experience available for an immediate start or short notice period. Complete remote working is available for the entirety of this contract and you would be working alongside an existing team of regulatory writers on a remote-basis. CMC Regulatory Writer Details: Experience with Biologics and Small Molecules Experience with Medical Devices Briefing Documents Clinical Trial Applications MAA/BLA/NDA registrations Post-approval submissions PIPs CMC template creation EMA and FDA experience would be preferential Global experience would be ideal for this role considering the scope of their current projects and the international reach of their operations. If this role is of interest to yourself, then please email your most up-to-date CV to or call Ollie Griffiths on . Alternatively, if this could be of interest to someone within your network, please encourage them to reach out to me directly.