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    International Compliance Manager - United Kingdom - Sobi - Swedish Orphan Biovitrum AB (publ)

    Sobi - Swedish Orphan Biovitrum AB (publ)
    Sobi - Swedish Orphan Biovitrum AB (publ) United Kingdom

    2 weeks ago

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    Description
    International Regulatory Affairs Manager (Remote)
    International Regulatory Affairs Manager | Sobi – SwedishOrphan Biovitrum AB (publ) | UK

    Sobi offers the opportunity to work at an international pharmaceuticalcompany focused on specialty pharmaceuticals meeting the high medical needsof rare disease patients and providing treatment and services to them.

    Our...

    Sobi offers the opportunity to work at an international pharmaceuticalcompany focused on specialty pharmaceuticals meeting the high medical needsof rare disease patients and providing treatment and services to them.

    Ouremployees come from a variety of backgrounds within research, healthcare,industry and the academic sphere.
    Job DescriptionOne of Sobi's four strategic pillars is to "Go Global". TheManager, Regulatory Affairs International supports our ambitiousgeographical expansion plans.

    Sobi is seeking to register some of ourexisting portfolio into new territories and to register several of ourdevelopment projects into the international region.

    This role is key todriving both the Regulatory strategy and execution.
    Key responsibilitiesRepresent International region in Global Regulatory Team and othercross-functional forums, for assigned productsDevelop International regulatory strategies and filing plans, inpartnership with the Global Regulatory Lead, and country leads, forassigned products in developmentPlan and create a core dossier for International, in partnership withcross-functional teams, for assigned productsDevelop regulatory strategies in assigned countries, in partnershipwith local Regulatory teamsManage, plan and direct all aspects for the successful preparation,submission and timely approval of marketing applications and post-approvalmanagement for assigned countriesProvide strategic guidance on regulations and changes in assignedcountriesSupport interactions with Health Authorities in assigned countriesQualificationsA University Degree in Life Sciences is required with 5 to 7 years ofindustry experience, of which at least 3 years of experience withinRegulatory Affairs (registration, development, maintenance)

    Experience of regulatory requirements in countries outside the US andEuropeVery good knowledge in written and oral English is required, knowledgeof any other languages would be an assetExperience from leading projects and cross-functional teamsAdditional InformationPersonal Attributes A strong team player, with the ability to work effectively in a teamsetting and interact with people of different cultural, seniority andfunctional backgroundsHighly self-motivated and able to drive activitiesExcellent communication skillsThe suitable candidate should demonstrate the Sobi Values; Care for ourpatients, for our colleagues and for our company, Ambition, Urgency,Ownership and PartnershipEnsure exemplary behaviour, ethics and transparency within the Companyand with regulatory agenciesIn addition, you should live up to our core values:
    Ambition,Ownership, Urgency, Partnership and Care.


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    remote, remote job, virtual, Virtual Job,virtual position, Work at Home, work from home
    When applying state you found this job on Remote Network.
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