Regulatory Operations Specialist

Vor 6 Tagen

Sydney, Österreich Healthcare Professionals Group Vollzeit
Benefits
• Regulatory operations role with a leading Pharmaceutical organisation
• Supportive and collaborative work environment
• Hybrid working environment

About the Company
Our client is a global leader in the pharmaceutical industry, specialisingin developing innovative medications and therapies. They are renowned for their commitment to improving patient outcomes and have a significant presence in the healthcare sector.
About the Opportunity
This 12-month assignment and is crucial for providing operational support for Regulatory Affairs in Australia & New Zealand. You will work within a supportive Medical & Regulatory team, collaborating closely with stakeholders to ensure regulatory compliance and audit readiness. You will manage project-based tasks, including CAPA from recent inspections, and use systemsfor data entry and documentation. Your role is vital for maintaining regulatory archives, supporting compassionate access programs, and contributing to process improvement initiatives. This role is key for maintaining the efficiency and compliance of our client's operations.
This role is a supporting role and if you are looking to secure a role in Regulatory Affairs in the Pharmaceutical Indusrythis could be a great role for you.
Hybrid working environment.

Duties
• Organiseand deliver training sessions on regulatory policies.
• Track and report on regulatory performance and financials.
• Ensure all regulatory documents are up-to-date and accessible.
• Prepare for and support internal and external audits
• Maintain and troubleshoot IT tools for Regulatory Affairs.
• Create and manage compliant regulatory documents.
• Administer compassionate access programs.
• Identify Process Improvements & streamline regulatory processes.

Skills and Experience
• Strong team working skills
• Experience in Regulatory Affairs position
• Strong organisational skills
• Ability to adapt to changing situations
• Proficiency in IT systems
• Proficient in Microsoft Office (Word and Excel)

Culture
Our client fosters a collaborative and supportive culture, prioritisinginnovation, professional growth, and a healthy work-life balance. They are committed to creating a positive and inclusive work environment.

How to Apply
Click apply or contact Gemma Staddon, Specialist Manager, on gstaddon@hpgconnect.com for a confidential discussion #J-18808-Ljbffr

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