Regulatory Affairs Specialist (CMC)
Job details
Apsida Life Science have partnered with a leading Pharmaceutical company who are looking for a Regulatory CMC specialist. The role involves the preparation of the (CMC) sections for an MAA submission., This includes authoring Modules 2.3 and 3 of the Common Technical Document (CTD).The ideal candidate should have the following qualifications:Regulatory CMC Writing Expertise: Demonstrated experience in drafting CMC documentation for regulatory submissions, with a focus on EMA submissions.Familiarity with EMA Guidelines: Comprehensive knowledge of EMA regulatory requirements and guidelines for MAA submissions.Experience with Investigational Drugs: Previous involvement with investigational drug products, especially those targeting neglected tropical diseases like sleeping sickness.Technical Background: Strong foundation in pharmaceutical sciences, chemistry, or a related discipline, with the capability to analyse and communicate complex scientific data effectively. PRB
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