Regulatory Affairs Associate

Benefits

• 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

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**

Duties

• 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

Culture

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.