Senior Regulatory Affairs Associate

Oct 11, 2021

Job Description

5 million. This is the number of products that Sandoz, a part of the Novartis Group of Companies, distributes into the Australian & New Zealand market every single month. Join the Team of the Year at Sandoz ANZ where you can actively contribute to this number by conducting regulatory feasibility assessments, formulating submission strategies and registering complex and interesting products to expand an already compelling Sandoz portfolio.

This is a great opportunity to use your existing Regulatory Affairs experience to be part of a business improving access to medicine for more people across the country.

As a Senior Regulatory Affairs Associate, your role will be to create and maintain value of products, processes and services through cross-functional team activity including product registration initiatives, and compliance of processes, services and products in the Australian and New Zealand markets.

Your responsibilities include, but not limited to:

• Identifies regulatory strategies for submissions of new generic and biosimilar products, collaborating cross functionally to ensure that high quality dossiers are submitted to TGA and Medsafe.
• Provides strategic product direction to teams on interaction and negotiates evidence with regulatory agencies.
• Ensures rapid and timely approval of new medicines, and continued approved status of marketed drugs
• Prepares PBAC submissions
• Provides advice to development and/or marketing teams on manufacturing changes, line extensions, technical labelling, appropriate regulations and interpretations.
• Drives process improvements and projects within the department

Minimum Requirements

Commercial OPS SIR SZ
Research & Development
Full Time

Senior Regulatory Affairs Associate

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