− 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
− 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