Regulatory Affairs and Pharmacovigilance Manager - Rare Disease focus SydneyPharmaceutical / Senior Operations Be part of building the Australian affiliate; be involved in bringing innovative rare disease products to Australian patientsBuild and lead the Regulatory and PV functionExposure to global businessHelp build the Australian affiliateThis global pharma company provides access to highly innovative therapies for patients in international markets. They commercialize highly innovative therapies helping to save and improve the lives of patients suffering from the most challenging diseases. Through their partnerships, they enable emerging biotech companies to navigate local complexities and to expand their reach to patients around the world.
As geographic expansion is an important aspect of their strategy, they have expanded into ANZ and are looking for a Regulatory Affairs and Pharmacovigilance Manager to lead the strategy and workflow for this function as their business continues to grow.
Reporting to the Chief Operating Officer, your key responsibilities will include:
Developing and implementing regulatory strategies for product submissions with the TGA and MedsafeDeveloping the required process and documents to support applicationsLeading the review and submission of regulatory dossiers in ANZManaging Regulatory and PV budgetsDeveloping internal capabilities in PVActing as the local QPPV for TGAEstablishing and maintaining local PV system and proceduresCreating and conducting PV training programsWorking closely and supporting third party vendorsWorking collaboratively with the local ANZ team and with the global technical operations teamsAs the successful candidate, you will have:
Tertiary scientific qualificationExtensive experience across a broad spectrum of regulatory and PV activities within pharma or biotechExperience in registration of rare disease products across ANZ will be highly regardedExperience in dealing with a diverse range of international partners and stakeholdersExperience in leading a team is highly regardedAbility to work cross functionally both locally and globallyMost of all, you will have an entrepreneurial spirit, the ability to thrive in an environment of rapid change; work effectively within cross-functional teams; will be highly innovative and creative and have a passion for highly innovative therapies that can dramatically improve patients' lives.
To apply for this role please submit your application in WORD format by clicking 'apply'; or contact Nicola Hurst on 0429 901 885 for further queries.
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