Senior Regulatory Affairs Associate

Benefits

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.

Duties

• 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

Culture

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.