Senior Regulatory Affairs Associate (BBBH34334) Sydney, Australia
Work with a global pharmaceutical company
Work in a friendly and supportive environment
About the company
This leading pharmaceutical company is at the forefront of innovation with an incredibly strong pipeline. Combining passion with research and development they have discovered many of the most utilised medicines across various therapeutic portfolios. This enables them to be instrumental in contributing to the health and well-being of patients worldwide
About the opportunity
A 12-month contract position for a Regulatory Affairs professional reporting to an experienced Regulatory Manager where you will ensure regulatory compliance of the prescription product portfolios. You will work closely with the quality and marketing teams to provide technical guidance and support
- Ensure submission and approval of regulatory applications, including maintenance of product registration
- Artwork approvals and label compliance
- PI and CMI updates
- Liaise with external regulators and internal colleagues
- Compliance activities in accordance to the MA Code of Conduct related to post market and promotional activities
Skills and Experience
- Minimum 3 years regulatory affairs experience in pharmaceutical industry
- Experienced with Cat 1 submissions
- Bachelor's degree or equivalent in a relevant scientific subject
- Knowledge of Australian regulatory requirements and guidelines
- Ability to adapt to challenging situations.
- Ability to work cross functionally
- Excellent team player, proactive and competent
- Effective verbal and written communication
This organisation has strong vision and values, offering a committed working environment to produce results. They encourage developmental and future career paths across other areas of the business.
How to Apply
Click apply or contact Davina Ocansey, Sourcing Consultant on +61 2 8877 8712 for a confidential discussion.