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KSJ GROUP PTY LTDAddress: Castle hill, NSW 2154Full Time Regulatory Affairs AssociateSalary $75,000 to $85,000 excluding superannuationAre you passionate about ensuring the safety and compliance of pharmaceutical products? Do you have experience in Pharmacovigilance? We are seeking for a Regulatory Affairs Associate withPharmacovigilance experience to join our dynamic team. As a key member, you will play a crucial role in managing regulatory processes and maintaining compliance with health authorities.Responsibilities:• Lead and deliver regulatory submissions within required timeframes and consistent with TGA and Medsafe requirements.• Ensure maintenance of allocated portfolio by carrying out activities associated with the change control process for CMC, artwork and labelling (Product Information).• Collaborate with team members to develop regulatory strategies for allocated portfolio and new medicine submissions.• Respond to TGA and Medsafe questions by liaising with local/global functions and external partners.• Maintain database systems in compliance with internal requirements.• Build and maintain effective collaboration with TGA and Medsafe personnel and other internal and external stakeholders.• Keep up to date with new TGA and Medsafe requirements and processes.• Contribute to departmental projects as required.• Collect, process, document, report, and follow up on adverse event reports.• Assist in the preparation, negotiation, approval, and maintenance of pharmacovigilanceagreements.• Efficiently process orders related to regulatory affairs.• Support internal and external audits, corrective action plans, and Health Authority inspections.• Work closely with other local departments to ensure seamless operations. Capacity toinvestigate and evaluate a problem to develop effective solutions.• Excellent communication skills (written and verbal).• Ability to multitask and work to deadlines.• Demonstrated ability to work well in a team environment and co-operate with others to achieve goals within specified timeframesThe minimum qualifications and experience for this role are:• Bachelor’s degree or equivalent in Pharmacy or Chemistry or Life Sciences. Pharmacy ispreferred.• Familiarity with local (Australia and New Zealand) and international regulatory guidelines.• Experience in regulatory with an awareness on TGA and Medsafe requirements andPharmacovigilance with an ability to assess the case reports with awareness on TGA andMedsafe PV guidelines.

Reporting to the Financial Controller, you be overseeing and managing the day-to-day aspects of the finance department including future planning. Other key responsibilities will include the following:Management of Finance team members including qualified accountants and Accounts teamOversight of the month-end process including ensuring the completion of the general ledger and Balance Sheet reconciliations and production of the P&L statementsCompletion of the commentary around variance to budgetCashflow forecastingOverseeing taxation returns such as BAS, FBT, and GST and liaison with external tax specialists.Oversee the external audit process.Managing the company's financial systemsProviding commentary and analysis around the company's performance to the management teamProviding financial advice to managers regarding initiatives to improve the company's financial performance.Responsible for overseeing insurance submission.Develop programs to automate work processes for continuous improvement.Assistance with various ad hoc projectsThe successful candidate will ideally have the following:CA or CPA qualification with previous experience in a similar financial leadership position within a sub-$100M organisation.Previous exposure to FMCG, manufacturing, industrial, or distribution sectors would be highly advantageous.Strong people leadership skills with a passion for developing high-performance teams.Exceptional business partnering abilities, capable of influencing stakeholders across the organisation.Ambitious and motivated individual with a focus on technical accounting and process improvement initiatives.High attention to detail.