Regulatory Affairs Associate

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.