KSJ GROUP PTY LTD
Address: Castle hill, NSW 2154
Full Time Regulatory Affairs Associate
Salary $75,000 to $85,000 excluding superannuation
Are 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 with
Pharmacovigilance 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 pharmacovigilance
agreements.
• 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 to
investigate 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 timeframes
The minimum qualifications and experience for this role are:
• Bachelor’s degree or equivalent in Pharmacy or Chemistry or Life Sciences. Pharmacy is
preferred.
• Familiarity with local (Australia and New Zealand) and international regulatory guidelines.
• Experience in regulatory with an awareness on TGA and Medsafe requirements and
Pharmacovigilance with an ability to assess the case reports with awareness on TGA and
Medsafe PV guidelines.
Address: Castle hill, NSW 2154
Full Time Regulatory Affairs Associate
Salary $75,000 to $85,000 excluding superannuation
Are 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 with
Pharmacovigilance 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 pharmacovigilance
agreements.
• 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 to
investigate 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 timeframes
The minimum qualifications and experience for this role are:
• Bachelor’s degree or equivalent in Pharmacy or Chemistry or Life Sciences. Pharmacy is
preferred.
• Familiarity with local (Australia and New Zealand) and international regulatory guidelines.
• Experience in regulatory with an awareness on TGA and Medsafe requirements and
Pharmacovigilance with an ability to assess the case reports with awareness on TGA and
Medsafe PV guidelines.
