Regulatory Affairs Associate (37534) North Sydney, Sydney, Australia

Salary: AUD100000 - AUD110000 per annum + Super + Bonus

 

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

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**

 

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

 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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