Regulatory Compliance Specialist
4 days ago
We are seeking a highly skilled Regulatory Affairs Associate to join our team in Sydney, Australia.
The successful candidate will be responsible for delivering regulatory strategy solutions to support the business and ensuring ongoing compliance with government, industry, and corporate requirements.
Key Responsibilities:- Provide strategic regulatory advice to local category teams and other business functions.
- Determine optimal regulatory strategies for new products and major life cycle projects.
- Evaluate chemicals and maintain records to ensure compliance with Australian AICIS requirements.
- Evaluate chemicals and maintain records to ensure compliance with NZ EPA requirements.
- Provide advice and submit dossiers to TGA (Australia) and Medsafe (NZ) to register new products or maintain current ones.
What You Will Need:
- Tertiary qualifications in chemistry, pharmacology, pharmacy, or related sciences.
- Minimum 3 years experience in a regulatory role in Pharmaceutical and/or FMCG Industry.
- Robust knowledge of Australian TGA and NZ Medsafe requirements.
- Experience with dossier review and submission to TGA and Medsafe.
- Working knowledge of Australian AICIS and NZ EPA requirements.
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