Regulatory Affairs Associate

Benefits

• Organisation with a huge growth platform in both ANZ and emerging markets
• Support an established team with a progressive culture
• Sydney CBD location, state of the art offices, and a flexible working environment

About the company

A global leader, with a commitment to innovation to bring both therapies and vaccines to patients, our client consistently expands. Recognised as best in class in clinical development and research, their commitment to bringing life changing medicine to market is unmatched.

About the opportunity

Covering a full spectrum of regulatory life-cycle management activities, your focus in this 12 month maternity cover contract will be to support the team across a prescription medicine portfolio. Assisting to support projects across the ANZ region, you will work both locally, and globally to ensure patients maintain access to iconic medications. Your problem-solving abilities will enable you to ensure all of the team submissions are completed in a timely manner

Duties

Supporting a suite of products you will assist with the implementation of new processes and analyse regulatory pipeline. You will liaise with relevant internal departments to ensure regulatory advise and support is provided cross functionally. External contact is key to ensuring regulatory requirements are met and submissions, including amendments are approved

Skills and Experience

• Tertiary education in Pharmacy or Science
• Experience in an ANZ pharmaceutical regulatory affairs role
• Proven success negotiating with both TGA/Medsafe
• Ability to adapt and respond in a fast-paced work environment

How to Apply

Click apply or contact Angela Barclay, Divisional Manager on +61 2 8877 8743 for a confidential discussion.