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    1 job found in Craigieburn, Victoria

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      • melbourne, victoria
      • permanent
      • full-time
      YOUR NEW COMPANYOur client is a global bio-pharmaceutical company. They are regarded as one of the most innovative companies in the world because of their approach to find solutions for unique, complex and previously neglected healthcare problems. They have created an environment where professionals are able to develop and grow. Their ethos is to present their employees with early opportunities to develop their skills and progress their career. YOUR NEW DUTIESYou will work as part of an established, high achieving, team in Melbourne. On offer is a generous base salary + 10% super + annual bonus. Regulatory: Maintain awareness of regulatory legislation and guidelines in EU, US andother relevant markets Apply for MA, variations and annual update reports in Europe including CH Update documentation as required in response to Regulatory Agencycomments/questions Prepare modules for the e-CTD dossier File substantial amendments as requiredCT Applications: As appropriate to the needs of the designated product portfolio: Prepare and/or collate all documentation to support clinical trial applications inEurope, US and Australasia Advise on the Investigator Brochure and Investigational Medicinal ProductDossier for Europe, US and Australasia Ensure investigational medicinal product is supplied to the study sites incompliance with regulatory approvals, including labelling, import permits WHAT YOU ARE / YOUR SKILLSETBachelor’s Degree in a scientific/pharmacy discipline or equivalentMUST have working knowledge of international regulatory standards in the areas of quality, safety and efficacy. WHAT'S IN IT FOR YOU?Our client is committed to providing a flexible work schedule, work/life balance and comprehensive on-the-job as well as remote training. Some of the fantastic perks are:Flexible work schedule Work/life balance Development opportunities If this SOUNDS LIKE YOU, please APPLY NOW to kick start your career with a leading healthcare company, or email your resume to pamela.panagopoulos@randstad.com.au.Please note: due to the volume of applications, only shortlisted candidates will be contacted.At Randstad, we are passionate about providing equal employment opportunities and embracing diversity to the benefit of all. We actively encourage applications from any background.randstad.com.auAt Randstad, we are passionate about providing equal employment opportunities and embracing diversity to the benefit of all. We actively encourage applications from any background.
      YOUR NEW COMPANYOur client is a global bio-pharmaceutical company. They are regarded as one of the most innovative companies in the world because of their approach to find solutions for unique, complex and previously neglected healthcare problems. They have created an environment where professionals are able to develop and grow. Their ethos is to present their employees with early opportunities to develop their skills and progress their career. YOUR NEW DUTIESYou will work as part of an established, high achieving, team in Melbourne. On offer is a generous base salary + 10% super + annual bonus. Regulatory: Maintain awareness of regulatory legislation and guidelines in EU, US andother relevant markets Apply for MA, variations and annual update reports in Europe including CH Update documentation as required in response to Regulatory Agencycomments/questions Prepare modules for the e-CTD dossier File substantial amendments as requiredCT Applications: As appropriate to the needs of the designated product portfolio: Prepare and/or collate all documentation to support clinical trial applications inEurope, US and Australasia Advise on the Investigator Brochure and Investigational Medicinal ProductDossier for Europe, US and Australasia Ensure investigational medicinal product is supplied to the study sites incompliance with regulatory approvals, including labelling, import permits WHAT YOU ARE / YOUR SKILLSETBachelor’s Degree in a scientific/pharmacy discipline or equivalentMUST have working knowledge of international regulatory standards in the areas of quality, safety and efficacy. WHAT'S IN IT FOR YOU?Our client is committed to providing a flexible work schedule, work/life balance and comprehensive on-the-job as well as remote training. Some of the fantastic perks are:Flexible work schedule Work/life balance Development opportunities If this SOUNDS LIKE YOU, please APPLY NOW to kick start your career with a leading healthcare company, or email your resume to pamela.panagopoulos@randstad.com.au.Please note: due to the volume of applications, only shortlisted candidates will be contacted.At Randstad, we are passionate about providing equal employment opportunities and embracing diversity to the benefit of all. We actively encourage applications from any background.randstad.com.auAt Randstad, we are passionate about providing equal employment opportunities and embracing diversity to the benefit of all. We actively encourage applications from any background.

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