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Regulatory Affairs Manager

4 months ago

Sydney, Australia Healthcare Professionals Group Full time

Benefits
• Challenging new role joining an organisation that is growing.
• Leadership position mentoring a small team
• Great environment with friendly & hard working team
• Competitive salary package + Bonus
• Supportive work-life balance

About the company
Join a renowned healthcare company dedicated to serving the medical and scientific community, providing innovative solutions in contrast agents, medical devices, imaging, and interventional radiology.

About the opportunity
As a Regulatory Affairs Manager, you will be responsible for managing pharmaceutical and medical device registrations in accordance with Australian and New Zealand health authority regulations. You will develop regulatory strategies, resolve complex registration issues, and collaborate with regional and corporate teams. This role is vital for maintaining compliance and ensuring timely product authorisations, directly impacting the company’s market presence and success.

Duties
• Drive registrations for pharmaceuticals and medical devices
• Develop regulatory strategies
• Resolve complex registration issues
• Maintain compliance with corporate and local regulations
• Collaborate with global teams
• Manage product label changes

Skills and Experience:
• 8+ years’ experience working in Regulatory Affairs in ANZ
• Experience within Regulatory Affairs in the Pharmaceutical Industry
• Management/Leadership skills
• Demonstrated understanding of the pharmaceutical and medical device industry procedures
• Experience in GDP and QMS
• Strong communication skills & excellent attention to detail

Culture:
Our client fosters a positive, collaborative work environment with a strong emphasis on employee growth, teamwork, and innovation. They promote excellence and support their employees in achieving their career goals.

How to Apply:
Click apply or contact Gemma Staddon, Specialist Manager on gstaddon@hpgconnect.com for a confidential discussion.