Arbetsbeskrivning

− 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