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
- 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
- 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
- Bachelor's degree or equivalent in Pharmacy or Chemistry or Life Sciences. Pharmacy is
- Familiarity with local (Australia and New Zealand) and international regulatory guidelines.
- Experience in regulatory with an awareness on TGA and Medsafe requirements and