Job Title Ref: BBBH24931_1645592160

Head of Regulatory Affairs

Salary 130000.00 - 150000.00 AUD

Location

Perth, Western Australia

2022-02-23

2022-03-23

Type Permanent

Sector Regulatory Affairs

i-Pharm https://www.i-pharmconsulting.com/

• TGA applications and documentation, including ARTG export submissions
• Prepare and finalise dossiers for marketing authorisations
• Interpret clinical research and medicine formulations
• Review and approve raw materials and product profiles for new products and commercial launches
• Review and approve product claim substantiations on existing product range as well as new products
• Manage pharmacovigilance requirements
• Reporting to Board and regulators as required
• Review formulations, labels, internal and external specifications, advertising materials, etc for regulatory compliance
• Establish and maintain formulation specifications
• Review requirements for EU and other regulatory environments
• Keep up to date with the current Therapeutics and Foods regulations
• Supervise and manage Regulatory Associate(s)
• Train and develop employees skills, ensuring competence and manage employee performance

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Consultant

Rachel Louise Jennings

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