Senior RA/QA Associate
On-siteSydney, New South Wales, Australia
Job Summary
Manage local and international CMOs and branded products by ensuring compliance with internal and external regulatory requirements. Develop regulatory strategies, prepare documentation for regulatory dossiers, drug master files, and licence renewals, and respond to questions from regulatory bodies. Review manufacturing and quality documentation including Change Controls, CAPA, and SOPs, while performing ISO 13485 and GMP audits. Review and approve all product labelling for compliance with relevant regulations. This 12-month fixed term position offers a view to permanency within an innovative pharmaceutical organisation focused on quality healthcare to improve patient care globally.
Required Qualifications
- Degree qualified (Bachelors or higher)
- Auditing ability in line with Australia GMP and ISO 13485 standards
- At least 5+ years pharmaceutical GMP experience in Regulatory Affairs and/or Quality
- Well versed in regulatory planning, submission preparations and discussions with regulatory bodies
- Proficient with project planning and skilled working knowledge of TGA and MedSafe regulations
- Stellar attention to detail, strong organizational skills and manage multiple tasks professionally
- Working/Living rights for Australia
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