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Associate Manager Regulatory Affairs (m/f)
Eingestellt von Hays aus Mannheim, Universitätsstadt
Projektbeschreibung
-Preparation and submission of new MAAs
-Submission and follow up of Clinical Trials/Clinical Trial Amendments; requiring close monitoring if changes in regulatory environment (CCMO, CGR)
-Follow up on regulatory product updates (variations), partnering with CROs in order to assure timely submission/implementation
-Prepare and implement new or changes to SOPs
-Supervision of Quality/Regulatory aspects of distribution in Switzerland; establish audit plans according to compliance needs; follow up on corrective action plans
-Advise Commercialbe a team-player -Able to prepare regulatory submissions in line with international or regional requirements and
scientific and company policies and procedures -Being able to assess promotional materials for clearance of use in Switzerland
-Able to handle routine labeling changes and drug listing; having attention to detail and being highly accurate
-Contribute to routine local process improvements, which have an impact on the working of the
Regulatory Affairs function; being process oriented -Excellent organization skills and ability to work on a number of projects with tight timelines is
required; able to set priorities
Weitere Qualifikationen: Regulatory affairs manager
-Submission and follow up of Clinical Trials/Clinical Trial Amendments; requiring close monitoring if changes in regulatory environment (CCMO, CGR)
-Follow up on regulatory product updates (variations), partnering with CROs in order to assure timely submission/implementation
-Prepare and implement new or changes to SOPs
-Supervision of Quality/Regulatory aspects of distribution in Switzerland; establish audit plans according to compliance needs; follow up on corrective action plans
-Advise Commercialbe a team-player -Able to prepare regulatory submissions in line with international or regional requirements and
scientific and company policies and procedures -Being able to assess promotional materials for clearance of use in Switzerland
-Able to handle routine labeling changes and drug listing; having attention to detail and being highly accurate
-Contribute to routine local process improvements, which have an impact on the working of the
Regulatory Affairs function; being process oriented -Excellent organization skills and ability to work on a number of projects with tight timelines is
required; able to set priorities
Weitere Qualifikationen: Regulatory affairs manager
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Sonstiges