Opportunity to work on exciting pipeline products including an NCE application
Global healthcare company
Broad product range - prescription, OTC, listed medicines
Excellent opportunity for growth and professional development
About the company
Our client is a global specialist pharmaceutical company that has been bringing transformative products to patients for over a century. Boutique organisation committed to helping people to live better and healthier lives.
About the opportunity
A great opportunity to join this highly successful global pharmaceutical team and work on a diverse range of products. The portfolio of products includes Rx, OTC, and listed products. You will be reporting to the Regulatory Affairs Manager ANZ.
The ideal candidate will have a willingness to learn and the flexibility and adaptability to work across the full product range.
**Exciting opportunity to support with upcoming NCE application**
Maintain regulatory compliance of products and ensure regulatory records are always up to date
Responsible for variation applications for the range of products
Support the RA Manager with new applications including one upcoming NCE
Liaise with key stakeholders and provide support and guidance on regulatory requirements
Review and evaluate proposed product labelling and manufacturing changes for regulatory filing
Involved in supporting maintenance of quality records and liaising with global team
Skills and Experience
Tertiary qualification in relevant scientific discipline
Minimum of 3 years of Australian regulatory experience in the pharmaceutical industry
Substantial knowledge of TGA and Medsafe requirements for therapeutic goods
Experience with compilation, submission and maintenance of regulatory files is an advantage
Excellent communication and presentation skills
Willingness to learn
Ability to work autonomously and collaboratively across sectors
Positive and friendly, team environment with solid support and mentoring.
How to Apply
Click apply or contact Joanna Murphy, Specialist Manager on +61 2 8877 8718 for a confidential discussion.
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