Senior Regulatory Associate or Regulatory Affairs Manager

About the Company
A global pharmaceutical company that strives to contribute to the wellbeing of patients worldwide. With leading pharmaceuticals in several areas such as oncology, diabetes, immunology and pain management, this company is renowned for their life changing products. Their passion for research and development has resulted in one of the strongest product pipelines in the company’s history.

About the Opportunity
During this 14-month contract, you will have the opportunity to work on the highly anticipated blockbuster pipeline product within the diabetes portfolio. This ground-breaking product is forecasted to be one of the most commercially successful and life-changing diabetes drugs in history. Working in a close-knit, collaborative team the Senior RA Associate will be responsible for executing the regulatory plan.

**For candidates with a higher level of experience, this role will be offered as a Regulatory Affairs Manager position. There will not be direct reports. You will be responsible for developing the regulatory strategy plan for the blockbuster product and executing this plan.

Duties

• Implement regulatory strategies to ensure successful registrations, line extensions and new indications whilst maintaining compliance of all products to regulatory and quality requirements.
• Continue to maintain environment of operational excellence by collaborating cross-functionally to achieve business and regulatory objectives
• Continue to cultivate successful collaborative relationships with regulatory agencies.

 
Skills and Experience

• Bachelor’s degree in a scientific related discipline
• At least three years’ experience in regulatory affairs working with innovator medicines
• Demonstrable experience of successful engagement with regulatory bodies, TGA and Medsafe
• Previous experience working on innovator Category 1 and NCE applications
• Demonstrated experience with Section 31 and pre-ACM responses is highly desired
• Excellent verbal and written communication skills
• Ability to network both internally and externally

Culture & Benefits
To support those who share their vision of making life better for people around world, the company offer various health and wellness programs to their employees. The company has been recognised for their cultural diversity as well as being one of the best places to work at the Australian HR awards for consecutive years. They have also been recognised as one of the most ethical companies and secured the top spot in the pharmaceutical innovation index.


How to Apply
Click apply or contact Joanna Murphy, Specialist Manager on +61 2 8877 8718 for a confidential discussion.