OneMD Sydney NSW Australia
2 months ago
Our client is a top complimentary medicine's company who are a household name in Canada, who are looking to expand their ANZ business and therefore require an experienced Regulatory affairs specialist to be the main point of contact for all things Regultory.
This position has been newly developed within the greater western Sydney region. This is a standalone role and offers seniority and a great family feel culture to work in.
Responsibilities include but are not limited to:
• Follow and adhere to all given instructions including work procedures, Standard Operating Procedures (SOPs), and current Good Manufacturing Practices (cGMP)
• Project manage, develop and oversee product registration/dossier collation in Australia and designated oversees countries, contributing to key strategic projects.
• Involvement in key quality and regulatory aspects of bringing new products to market.
• Responsible for assessing the regulatory impact on any change control.
•... Responsible for all ARTG regulatory applications (product listings, permitted
• indications/substantiations GMP preclearance, TGA product enquiries)
• Completion of a bachelor’s degree in a science discipline
• Minimum 5 years’ experience in Regulatory Affairs either in pharmaceutical, nutraceutical or complementary medicine manufacturing industry
• Capable of dealing with government and other regulatory bodies
• Thorough knowledge of therapeutic goods formulation, manufacturing and quality processes
What's on offer:
• Competitive Base salary + Super
• Hybrid work from home/office
• Flexible start and finish times
• Fantastic family feel culture
• Strong product pipeline
To apply for this role, please reach out to Nicola Davison on 04727 29731
Sydney NSW Australia
Regulatory Affairs Specialist Sydney NSW jobs
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