Karo Healthcare AB jobb

− Responsible for global regulatory submissions (for a specific portfolio/region). − Creation and/or review of regulatory documentation (except for core dossier documentation) as relevant for submissions. − Artwork maintenance, ensuring artwork compliance in line with regulations, including serialisation requirements and input/requests in GLAMS artwork system − Maintaining current knowledge base of existing and emerging regulations, standards, or guidance documents. − Providing regulatory input to cross functional teams/projects. − Responsible for RA related activities for already registered products/pack sizes to be launched in new markets. − Coordinating subsidiaries, partners and consultants on applicable market(s) including publishing partner. − Coordinating Product Information translations, ensuring updates of applicable national databases and product monograph websites. − Contributing to SOP development and maintenance. − Veeva RIM system maintenance and compliance. − IDMP/SPOR maintenance and compliance Experience: − University degree in Life Science − Good understanding of regulatory requirements and applicable legal frameworks − Extensive record of Variation management − Experience of regulatory procedures within the EU (NP, DCP and MRP). Global RA experience is meritorious. − Experience from artwork maintenance and associated label requirements − Record of cross-functional duties and collaboration − Strong working relationship/experience with regulatory authorities