NewListed today

Senior RA/QA Associate

Axia HR

Pharmaceuticals & Medical Devices

Location: On-site, On-site
Type: Contract

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…

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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

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Senior Regulatory Affairs Professional

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NewListed today

Senior RA/QA Associate

Axia HR

Pharmaceuticals & Medical Devices

Location: On-site, On-site
Type: Contract

Your match

See how you fit

Scored against this job in seconds

Your account

Your profile and your match for this job appear right here.

About the role

Your new company

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

Newtoday