Regulatory Contractor

vor 1 Tag

BaselCity, Schweiz Barrington James Vollzeit

Job DescriptionRegulatory Contractor – full-time 6 months contract (remote)We are seeking a Regulatory Affairs Contractor to support one of our small biotech clients, including the preparation and submission of initial Marketing Authorization Applications (MAAs).September start dateFully remote, but preference to have candidates based in Spain, Poland or Switzerland.Key responsibilities:Lead or support EU regulatory submissions, including CTA applications and amendments via CTISCentralised MAAs for New Active Substances (NAS)Authoring/preparing Paediatric Investigation Plans (PIPs), waivers and modificationsSupporting preparation of scientific advice meetingsSupport in monitoring, assessing, and maintaining current awareness of evolving regulations and guidance documents relevant to ongoing studiesRequired experience:Strong CTA and CTIS experienceProven experience authoring/leading PIP'sMAA filing/submission experienceStrong understanding of EU regulatory landscape and clinical trial regulations including scientific advice, meetings with EMA and national HA'sOncology experience is desirable

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