Senior Regulatory Affairs Associate
- Sydney
- Salary:Competitive salary package
- SalaryCompetitive salary package
- LocationSydney
- Job type Full Time
- DisciplineRegulatory Affairs
- ReferenceBH-43326
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Senior Regulatory Affairs Associate
Job description
Benefits
• Excellent opportunity for progression and development opportunities
• Work with a global specialty pharmaceutical company
• Collaborative culture with a strong focus on quality and innovation
About the company
Part of a leading global specialty pharmaceutical group with a strong presence across the APAC region. The business is committed to improving patient access to important medicines and maintains high standards for quality, compliance and cross-regional collaboration.
About the opportunity
We are seeking a Senior Regulatory Affairs Associate to join a high-performing team. Reporting to the Regulatory Director, you will support product registration and variation activities, dossier compilation and publishing, and submission tracking across the region. You will build strong working relationships with cross-functional teams and external partners to ensure timely, compliant delivery of submission activities.
Duties
• Prepare and manage product registration and variation submissions in line with local regulatory requirements
• Conduct gap analyses to ensure dossier compliance prior to submission
• Develop and review product labelling, product information and consumer information in collaboration with Medical and Marketing teams
• Coordinate dossier compilation and electronic publishing activities across the region
• Maintain GMP evidence and ensure timely pre-clearance for manufacturing sites where required
• Support due diligence activities for potential new product acquisitions
• Manage incoming/outgoing agency correspondence and communicate outcomes to stakeholders in a professional and timely manner
• Maintain submission tracking, regulatory documentation and compliance with internal SOPs and QMS standards
• Contribute to continuous improvement and a quality-focused mindset within the team
Skills and Experience
• Bachelor’s degree in Science or a related discipline
• Minimum 4 years’ experience servicing the Australia/New Zealand region or similar markets
• Strong written and verbal communication skills and a good eye for detail
• Proactive, organised and able to manage competing priorities
• Comfortable working cross-functionally in a fast-paced environment
Culture
The organisation encourages collaboration, ownership and continual learning. The team values quality and teamwork and provides opportunities for professional growth.
How to Apply
If this sounds like a fit, please click apply or contact Gemma Staddon on +61 2 8877 8776 for a confidential discussion.
• Excellent opportunity for progression and development opportunities
• Work with a global specialty pharmaceutical company
• Collaborative culture with a strong focus on quality and innovation
About the company
Part of a leading global specialty pharmaceutical group with a strong presence across the APAC region. The business is committed to improving patient access to important medicines and maintains high standards for quality, compliance and cross-regional collaboration.
About the opportunity
We are seeking a Senior Regulatory Affairs Associate to join a high-performing team. Reporting to the Regulatory Director, you will support product registration and variation activities, dossier compilation and publishing, and submission tracking across the region. You will build strong working relationships with cross-functional teams and external partners to ensure timely, compliant delivery of submission activities.
Duties
• Prepare and manage product registration and variation submissions in line with local regulatory requirements
• Conduct gap analyses to ensure dossier compliance prior to submission
• Develop and review product labelling, product information and consumer information in collaboration with Medical and Marketing teams
• Coordinate dossier compilation and electronic publishing activities across the region
• Maintain GMP evidence and ensure timely pre-clearance for manufacturing sites where required
• Support due diligence activities for potential new product acquisitions
• Manage incoming/outgoing agency correspondence and communicate outcomes to stakeholders in a professional and timely manner
• Maintain submission tracking, regulatory documentation and compliance with internal SOPs and QMS standards
• Contribute to continuous improvement and a quality-focused mindset within the team
Skills and Experience
• Bachelor’s degree in Science or a related discipline
• Minimum 4 years’ experience servicing the Australia/New Zealand region or similar markets
• Strong written and verbal communication skills and a good eye for detail
• Proactive, organised and able to manage competing priorities
• Comfortable working cross-functionally in a fast-paced environment
Culture
The organisation encourages collaboration, ownership and continual learning. The team values quality and teamwork and provides opportunities for professional growth.
How to Apply
If this sounds like a fit, please click apply or contact Gemma Staddon on +61 2 8877 8776 for a confidential discussion.