Listed 8 weeks ago
Senior RA/QA Associate
Axia HR
HR
- Location
- Sydney, NSW
- Type
- Full-time
About the role
Your new company
An innovative pharmaceutical organisation that is over 30 years established here in Australia is looking for a Senior Regulatory Professional to join their dynamic and collaborative organisation. This opportunity is a 12-month fixed term position with view to permanency. Boasting a broad range of branded products across a range of therapeutic areas, their focus is on quality healthcare to improve patient care on a global level.
Your new role
Reporting directly into the Regulatory Affairs manager, you will assist with management of local and international CMO's. You will be responsible for, but not limited to:
- Management and leadership of branded products ensuring compliance with all internal and external regulatory requirements
- Managing on-going compliance requirements and develop regulatory strategies to support the business
- Preparing documentation for regulatory dossiers, drug master files, licence renewals and responses to questions from regulatory bodies
- Diligent and organised in your approach to workflow for legal and regulatory functions
- Review manufacturing and quality documentation and procedures e.g. Change Controls, CAPA, SOP
- Performing ISO 13485 and GMP audits on CMO's
- Review and approve all product labelling for compliance with relevant regulations
About You
- 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
If interested please apply below or contact Sorcha Hayward @ +61458612522 for a confidential discussion