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Job DescriptionOwn post-marketing PI and CMI safety updates across AU & NZ portfoliosHandson Pharmacovigilance & Regulatory Affairs role within a global generics organisationPermanent parttime | Fully remote | Highautonomy positionAbout the OrganisationHealthcare Professionals Group (HPG) is partnering with a globally established pharmaceutical organisation with a strong presence across Australia and New Zealand. Operating a diverse generics and hospital portfolio, the business is recognised for its commitment to regulatory compliance, product quality, and patient safety. With increasing portfolio complexity and ongoing regulatory requirements, the organisation is strengthening its local pharmacovigilance and regulatory capability to support postmarketing safety obligations across ANZ.About the OpportunityThis is a handson Pharmacovigilance & Regulatory Affairs Specialist role focused on postmarketing safety and regulatory maintenance. Reporting into senior local leadership, you will take ownership of Product Information (PI) and Consumer Medicine Information (CMI) safety updates, ensuring ongoing compliance with TGA and Medsafe requirements across marketed and nonmarketed products.The role is well suited to an experienced regulatory professional with strong generics and lifecycle management experience, comfortable working autonomously in a fully remote environment. While structured as a permanent parttime position (23 days per week), there is clear potential for additional scope and workload as the portfolio continues to evolve.DutiesOwn and deliver PI and CMI safety updates across Australian and New Zealand portfoliosConduct regular PI safety reviews against innovator reference safety information and global safety updatesManage TGA and Medsafe submissions related to PI and CMI updates within required regulatory timelinesReview regulatory databases to identify safetydriven update requirementsSupport maintenance and ongoing compliance of the local pharmacovigilance system, including SOPs and safety agreementsAddress and close CAPAs arising from pharmacovigilance audits and inspectionsPerform monthly reconciliation activities to support PV systemMaintain accurate documentation and ensure ongoing adherence to ANZ pharmacovigilance requirementsSkills and ExperienceDegree qualified in Life Sciences, Pharmacy, Nursing or a related disciplineMinimum 35 years'' experience in Regulatory Affairs and/or Pharmacovigilance within pharmaceuticalsStrong handson experience with PI and CMI lifecycle management and postmarketing variationsSolid working knowledge of TGA and Medsafe regulatory frameworksExperience within generics or established product portfolios highly regardedProven ability to work autonomously, manage timelines, and deliver accurate regulatory outputsStrong written communication skills and exceptional attention to detailBenefitsPermanent parttime role (23 days per week) with flexibilityFully remote working arrangementHighautonomy position with ownership of critical regulatory activitiesOpportunity for role and scope expansion over timeSupportive local leadership within a globally backed organisationCompetitive base salary, prorated, plus superHow to ApplyTo explore this opportunity in confidence, please contact:Rohan Lallbeeharry Senior Recruitment Consultant, HPG | [email protected] | +61 485 860 660 #J-18808-Ljbffr