Regulatory Affairs Specialist

Benefits

• Excellent company culture
• Leading pharmaceutical company
• Undertake a role that will significantly improve the lives of patients

About the Company

This large, global pharmaceutical company work collaboratively together to positively impact the lives of patients around the world. Their purpose and mission is to innovate and bring therapies to patients that will significantly improve lives.

About the role

This role will be responsible for managing all regulatory affairs activities with a focus on the CMC section of the regulatory fillings.

Responsibilities include:

• Manage content of the regulatory dossiers
• Preparation and review of CMC related information and documentation
• Managing new product registration and lifecycle submissions
• Support all CMC related submission activities
• Contribute to quality reviews and risk assessment by providing regulatory expertise

Skills & Experience Required

• 1-3 years of experience in Regulatory Affairs experience in pharmaceutical industry
• Sound knowledge and experience in CMC related documentation and submissions
• Excellent communication, project management, planning and presentation skills
• Strong team player
• Ability to work with minimal supervision

How to Apply

Please follow relevant link to apply. Alternatively, please call Jo Turner on 03 9938 7120 or email at jturner@hpgconnect.com