Regulatory Affairs Specialist
2 weeks ago
We are seeking an experienced Regulatory Affairs Specialist to join our team.
The successful candidate will be responsible for delivering high-quality regulatory solutions across Australia and New Zealand.
The role involves preparing, reviewing, and submitting regulatory dossiers to Medsafe and TGA, including New Medicine Applications (NMAs), Variations (Category 1), Notifications, product information updates, and safety-related changes.
The ideal candidate will have a bachelor's degree in science, pharmacy or a related discipline and a minimum of 5 years' experience in regulatory affairs.
They will also have good knowledge of legislation, regulations, guidelines and working procedures within Australia, New Zealand and the JAPAC region.
The Regulatory Affairs Specialist will work closely with cross-functional teams to ensure compliance with regulatory frameworks and guidance.
The role requires strong problem-solving and project management skills, as well as excellent written and oral communication skills.
Key Responsibilities:- Prepare, review and submit regulatory dossiers to Medsafe and TGA.
- Ensure compliance with regulatory frameworks and guidance.
- Coordinate regulatory projects and track deliverables, timelines and risk mitigation plans.
- Liaise with medical, safety, quality and supply chain teams for submission-ready documentation.
- Bachelor's degree in science, pharmacy or a related discipline.
- Minimum 5 years' experience in regulatory affairs.
- Good knowledge of legislation, regulations, guidelines and working procedures within Australia, New Zealand and the JAPAC region.
- Strong problem-solving and project management skills.
- Excellent written and oral communication skills.
- Collaborate with industry experts in regulatory affairs.
- Contribute to projects that drive real-world impact on patient care.
- Enjoy a flexible, hybrid work model and commitment to work-life balance.
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