Global Regulatory Affairs Manager
Karo Healthcare AB / Biomedicinjobb / Stockholm
2026-06-08
Visa alla biomedicinjobb i Stockholm,
Solna,
Lidingö,
Sundbyberg,
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hela Sverige Visa alla jobb hos Karo Healthcare AB i Stockholm − 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
Så ansöker du Sista dag att ansöka är 2026-06-22
E-post:
people@karo.com Arbetsgivarens referens Arbetsgivarens referens för detta jobb är "Regulatory Affairs Manager".
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Karo Healthcare AB (org.nr 556309-3359)
Klara Norra Kyrkogata 33 (
visa karta)
111 22 STOCKHOLM
Jobbnummer 9951328