Consultant, Regulatory Affairs
4 weeks ago
Consultant, Regulatory Affairs & Operations 347
Australia, Melbourne
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Hybrid
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Life Cycle
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Regulatory Affairs & Operations
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Permanent contract
We’re looking for a Consultant to join our Regulatory Affairs & Operations team. Play a key role in delivering high-quality regulatory outcomes, optimising submission strategies, and contributing to the continuous improvement of regulatory processes and team capability.
About the Role:
The Consultant operates within theRQCfunction, supporting the development, preparation, and submission of regulatory applications forprescription medicines and other therapeutic goodsacrossAustralia and New Zealand.This role involves managing regulatory projects from planning through execution, working collaboratively with internal teams and clients to ensure compliance with local regulatory requirements. The Consultant plays a key role in delivering high-quality regulatory outcomes, optimising submission strategies, and contributing to the continuous improvement of regulatory processes and team capability.
Key Responsibilities:
- Prepare, review, and submit regulatory submissions for new product registrations and lifecycle maintenance variations to TGA and Medsafe.
- Ensure compliance with TGA and Medsafe regulatory frameworks.
- Manage clients and projects for assigned activities including tracking deliverables, budgets and timelines.
- Liaise cross-functionally with medical, safety, quality, and supply chain teams for compilation of submission-ready documentation.
- Respond to agency queries and deficiency letters within defined timelines.
- Maintain internal regulatory trackers, databases, and submission archives in accordance with internal and client procedures.
- Monitor changes in local regulatory framework and communicate impact assessments as needed.
Requirements:
- Bachelor’s or master’s degree in pharmacy, Life Sciences, or a related field.
- 3 to 4 years of Regulatory Affairs experience with direct involvement in prescription medicine regulatory submissions.
- Hands-on experience with TGA and Medsafe regulatory procedures, including preparation and submission of CTD dossiers.
- Strong project management experience in regulatory operations, with proven ability to coordinate cross-functional inputs and meet submission timelines.
- Sound understanding of regulatory requirements across the Australian and New Zealand markets.
- Excellent written and verbal communication skills with strong attention to detail.
- Ability to manage multiple priorities and work independently in a dynamic regulatory environment.
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