Regulatory Affairs Specialist
10 hours ago
The ideal candidate will be responsible for supporting the development, preparation, and submission of regulatory applications for prescription medicines and other therapeutic goods across Australia and New Zealand.
Key Responsibilities- Preparing, reviewing, and submitting regulatory submissions for new product registrations and lifecycle maintenance variations to TGA and Medsafe.
- Ensuring compliance with TGA and Medsafe regulatory frameworks and managing clients and projects for assigned activities including tracking deliverables, timelines.
- Liaising cross-functionally with medical, safety, quality, and supply chain teams for compilation of submission-ready documentation.
- Responding to agency queries and deficiency letters within defined timelines, maintaining internal regulatory trackers, databases, and submission archives in accordance with internal procedures.
A sound understanding of regulatory requirements across the Australian and New Zealand markets is essential, as well as possessing excellent written and verbal communication skills with strong attention to detail.
Requirements- Bachelor's or Master's degree in pharmacy, Life Sciences, or a related field.
- 3-4 years of Regulatory Affairs experience with direct involvement in prescription medicine regulatory submissions.
This role requires someone who can work independently and collaboratively as part of a team to deliver high-quality results.
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