Regulatory Affairs Project Manager

12 month, 100% remote, Full time Max 55 EUR/hour

The Project Manager will collaborate closely with the RA Manager EU and the Client’s Leadership Team to coordinate workload and prioritisation for regulatory consultants. Core responsibilities include: Regulatory Labeling & Artwork Management: Creating and updating country label deviations, national SmPCs/PILs, CCDS compliance checks, preparing local abbreviated PI, supporting annex translations for centralised products, and updating/approving local artworks. Regulatory Submission Activities: Preparing and submitting national variations, renewals, PSURs, RTQs, MAAs, and MRP/DCP documentation (including via Veeva Vault RIM and non-CESP routes); updating submission records and approval dates. Local Regulatory Support & Intelligence: Providing in-country regulatory intelligence, supporting local MAAs, conducting SOP reviews/updates, coordinating with local affiliates, and acting as operational liaison with third-party partners and stakeholders. Regulatory Assessments & Compliance: Performing assessments for CMC, labelling, and other variations; reviewing RA data for PV reporting; managing actions related to market cessation, sunset clauses, and MA withdrawals. Stakeholder and Authority Interface: Serving as point of contact for Health Authorities and responding to medical information requests; informing global/reliant markets of reference product changes; supporting submission of educational materials and local change control requests. Administrative & Fee Activities: Calculating and obtaining approval of regulatory fees and requesting payment/PoP.