Benefits…

• Opportunity to develop and enhance skills in regulatory affairs and pharmacovigilance in the pharmaceutical industry
• Make an impact by ensuring that the company's products meet regulatory requirements and are safe for consumers
• Working with evolving technologies
• Modern offices located in Sydney, CBD, close to public transport
• Hybrid flexible working environment
• 12 month assignment - hourly rate

About the company…
A distinguished leader in the Pharmaceutical industry, offering ethical solutions with their core purpose to improve the lives of people around the world. Renowned for breakthrough medicines and transforming patients lives all around the world.

About the role…
My client are seeking a highly motivated and detail-oriented individual to join the team as a Regulatory Operations Specialist in Australia & New Zealand. The successful candidate will provide operational support for Regulatory Affairs and Pharmacovigilance processes, assist in compliance and audit readiness activities, and support the implementation of process improvements. This role involves providing support for the conduct of compassionate access programs, which allows for the provision of potentially life-saving treatments to patients in need.

What you'll be doing…

• Coordinate and support training and job aids for Regulatory Affairs and Pharmacovigilance policies.
• Track metrics and provide support for Regulatory Affairs and Pharmacovigilance deliverables.
• Provide support for invoice processing and financial reporting.
• Implement processes to ensure complete and up-to-date regulatory archives.
• Support internal and external audits and collaborate with Medical, Quality, and Ethics and Compliance personnel.
• Maintain up-to-date and accurate internal Regulatory Affairs and Pharmacovigilance IT tools.
• Create and maintain compliant documentation within documentation systems, including Veeva Vault and RIM.
• Conduct and report on compassionate access programs to health authorities.
• Support localisation of global materials.
• Identify and support implementation of local process improvement opportunities.
• Support audit readiness initiatives.
• Support training and education on Regulatory Affairs and Pharmacovigilance matters for affiliates.

What you need…

• Proven ability to work well in a team, including experience working remotely.
• Demonstrated ability to adapt to changing situations.
• Strong IT acumen, including experience working with complex and evolving IT systems
• Proficiency in Microsoft Office, particularly Word and Excel
• Experience in document management and editorial reviews preferred
• Previous experience in the pharmaceutical or similar relevant industry

Culture
You will collaborate with a team of leaders who are renowned for their supportive nature and progressive incentives that align with traditional values. This company places a strong emphasis on delivering first-class customer and patient care, and fosters a stable and ethical work environment that is valued by both its local and global team members.

How to Apply…
Your application will be reviewed by Francesca Strange. Feel free to call Fran on 02 8877 8719 for a confidential discussion.

About Us…
Healthcare Professionals Group, a leading recruitment agency for biotechnology, medical devices, pharmaceutical, and scientific companies. Visit www.hpgconnect.com for more job opportunities in the pharmaceutical, medical, and healthcare industries.