- SalaryNegotiable
- LocationNorth Shore
- Job type Full Time
- DisciplineRegulatory Affairs
- Reference37631
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Regulatory Affairs Associate
Job description
About the company
An established multi-national, biopharmaceutical company with product range across reproductive health, urology, and gastroenterology.
About the opportunity
Working within the regulatory team your main responsibility will be to monitor and maintain local and overseas compliance with regulatory affairs across your product portfolios. You will work closely with cross functional teams to provide technical guidance and support
Duties
- Prepare and submit regulatory submissions, responses, and notifications to TGA
- Maintenance of product registrations
- GMP clearance
- PI, CMI, and label updates
- Artwork approvals
- Liaise with TGA and internal colleagues
- Provide technical support to quality and marketing teams
Skills and Experience
- Minimum 2 years local regulatory affairs experience in pharmaceutical industry
- Knowledge of Australian regulatory requirements and guidelines
- Tertiary qualification desirable in Pharmacy, Pharmacology or relevant science subject
- Strong relationship with the TGA and or Medsafe
- Ability to work cross functionally
- Excellent attention to detail, proactive and competent
- Effective verbal and written communication
How to Apply
Click apply or contact Davina Ocansey, Recruitment Consultant on +61 2 8877 8712 for a confidential discussion.
