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:
Bachelors 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.