Vacant job

− 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 serialization 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.