Work in a friendly and supportive environment
Smaller team environment offers opportunity to gain a breadth of experience
Innovative and global organisation
Flexible working arrangement
Work with very rare products
About the company
Our client is a medium speciality bio-pharmaceutical organisation developing and innovating products in the areas of women's health, gastroenterology and urology/oncology. With a long-standing manager who is down to earth and personable
About the opportunity
Support the regulatory affairs function by providing a comprehensive regulatory affairs service including submitting new registration application and variations of existing registered products to ensure the compliance of all product with the TGA regulations and requirements.
- Prepare and submit allocated regulatory submissions/variations, responses, and notifications to TGA
- Develop PI, CMI, labels
- Ensure all new and existing products are maintained on the ARTG
- Act as company expert in the preparation of electronic submissions (NeeS and e-CTD)
- Receive and process Special Access Scheme Requests
- Submit applications for GMP clearance and maintain current GMP evidence
- Prepare and submit device regulatory submissions
- Performing product recalls
Skills and Experience
- Pharmacy Degree
- 5 years of working experience and 3 year of regulatory affairs experience
- Knowledge of international guidelines and national legislation related to drug registration and Pharmacovigilance
- Capable of developing and implementing regulatory strategy
- Must be well organized and able to multi-task in an environment of rapidly changing priorities
Join a small team environment with a long standing management.
How to Apply
Click apply or contact Davina Ocansey, Sourcing Consultant on +61 2 8877 8712 for a confidential discussion.
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