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Healthcare Regulatory Specialist
2 weeks ago
As a Regulatory Consultant, you will play a pivotal role in delivering high-quality regulatory outcomes for prescription medicines and other therapeutic goods across Australia and New Zealand. This involves overseeing regulatory projects from planning through execution, collaborating with internal teams and clients to ensure compliance with local regulatory requirements, and contributing to the continuous improvement of regulatory processes and team capability.
Key Responsibilities:
- Developing, reviewing, and submitting regulatory submissions for new product registrations and lifecycle maintenance variations to TGA and Medsafe
- Ensuring adherence to TGA and Medsafe regulatory frameworks
- Managing clients and projects for assigned activities, including tracking deliverables, budgets, and 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 and client procedures
- Monitoring changes in local regulatory framework and communicating impact assessments as needed
Requirements for Success:
- 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
- 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
