Key Skills for Regulatory Affairs
* Job Description:
We are seeking a highly motivated and skilled Regulatory Consultant to join our team. The successful 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.
* Responsibilities:
1. Prepare, review, and submit regulatory submissions for new product registrations and lifecycle maintenance variations to TGA and Medsafe.
2. Evaluate and ensure compliance with TGA and Medsafe regulatory frameworks.
3. Manage projects and track deliverables, timelines, and activities.
4. Liaise cross-functionally with medical, safety, quality, and supply chain teams for compilation of submission-ready documentation.
5. Analyze and respond to agency queries and deficiency letters within defined timelines.
6. Maintain internal regulatory trackers, databases, and submission archives in accordance with internal procedures.
7. 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.
* At least 3 years of experience in Regulatory Affairs 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 skills with 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.