Full Time Regulatory Affairs Associate

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.