- Opportunity to work on exciting pipeline products including an NCE application
- Global healthcare company
- Broad product range - prescription, OTC, listed medicines
- Competitive salary
- Excellent opportunity for growth and professional development
- Flexible working
About the company
A global specialist pharmaceutical company that has been bringing transformative healthcare 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 solutions
- 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
Very positive and close-knit environment, where flexibility and teamwork are at the heart of what they do.
How to Apply
Click apply or contact Joanna Murphy, Specialist Manager on +61 2 8877 8718 for a confidential discussion.
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