Regulatory and Technical Associate

Ask yourself this:​

• Would you like to contribute to the industry and positively make an impact on people's lives?

About the company:

Innovative pharmaceutical company looking to expand the business by double in the next 2 years. They develop and manufacture over-the-counter medicine and medical devices etc for the Australian and New Zealand markets.

The Job:​

• Review of existing registration dossiers for pharmaceutical products
• Identify discrepancies that may influence the likely success or failure of the application

• Review of specification of raw materials, intermediates, and finished products are compliant with the regulatory standards
• Able to check that all labelling, promotional materials, and packaging materials meet Australian regulatory requirements
• Ensure all documentation is in appliance with TGA regulatory requirements
• Provide technical assistance to manufacturers and regulators in GMP, dossier development, and submissions through audits.
• Recognise the latest manufacturing trends and regulations requirements
• Develop technical documents and tools
• Conducting audits to assess compliance with local and international standards
• Working with manufacturers to develop strategies and tools to identify deviations and non-compliance

You:​

• Minimum 2 years prior experience working in the pharmaceutical industry

• Experience with new product development and formulations
• Excellent communication skills with a Professional approach
• Advanced working knowledge of Microsoft Word, Excel, PowerPoint, and Outlook

• Knowledge of pharmaceutical manufacturing processes
• Available to work full-time on site
• Must be eligible to work in Australia (Australian Citizen or appropriate Visa holder)​

ABOUT i-PHARM CONSULTING

i-Pharm Consulting is a specialist Recruitment Company servicing the global Pharmaceutical industry. We provide both permanent and contract staff to a wide range of Pharmaceutical, Medical Device, Biotechnology and Contract Research Organisations (CROs). i-Pharm has specific expertise in Clinical Research, Medical Affairs, Regulatory Affairs, Pharmacovigilance, Quality Assurance and Bioinformatics.

www.i-pharmconsulting.com

TO APPLY

If you would like to discuss this vacancy further, please call Alyssa Kang on +61 (0) 2 8310 5852, or email akang@i-pharmconsulting.com. If this role is not suitable, Alyssa is also available to discuss other possible positions or answer any general questions regarding your career and the current market.