Regulatory Affairs Associate

Benefits:
• Join a collaborative team and work with a supportive leader
• Work with a global company providing innovative solutions
• Flexible working environment & competitive salary package + company benefits

About the company:
Our client is a global company with a strong presence in Australia. They specialize in developing innovative therapies for a range of diseases and medical conditions and are renowned for their research and development capabilities. They are constantly exploring new opportunities to expand their reach and impact in the healthcare industry and are seeking a highly skilled and motivated professional to join their team.

About the opportunity
This is a great role for someone with a background in the medical device industry to take on a challenging and rewarding role in a fast-paced environment. As the Regulatory Affairs Associate, you will be responsible for registering new medicines and medical devices and ensuring compliance with relevant regulations. In this role you will develop quality registration dossiers, submit timely applications and respond to regulatory agency requests for information. You will also be responsible for reviewing advertising and promotional materials.
To be successful in this role, you will need to be results-oriented, self-motivated and able to work autonomously. This is an exciting opportunity to join a close-knit team of professionals who work together to bring products to the market and manage their lifecycle.
A 12-month contract with the opportunity to work from home.
 

Duties
• Critically appraise dossier packages and resolve deficiencies prior to submission
• Prepare and submit medical device and medicines registration applications
• Provide accurate and timely regulatory advice to the business teams.
• Review artwork and labelling for compliance with regulations
• Identify process improvements
• Maintain local regulatory generated registration details
• Assist with regulatory monthly reports


Skills and Experience
• Tertiary qualifications in a pharmacy or a life science discipline.
• Experience working in the Medical Device industry in a regulatory affairs role.
• Knowledge of Australian and New Zealand medicine and medical device regulatory requirements and processes.
• An understanding of the new product development and commercialisation processes
• Good understanding of the advertising code of practices and some experiences in reviewing promotional materials.
• Effective written and verbal communications.
• Self-motivated & results orientated

Culture:
• Fast-paced, dynamic and innovative culture
• Encourages diversity and creativity

How to Apply
Click apply or contact Gemma Staddon, Specialist Manager on 02 8877 8776 for a confidential