Senior Regulatory Submission Specialist responsible for delivering high-quality clinical trial regulatory submissions across Australia and New Zealand. The role involves managing submission activities, collaborating with regulatory and ethics bodies, and contributing to process improvement initiatives.
Requirements
- Minimum 3 years of relevant regulatory experience in a CRO or pharmaceutical company.
- Strong working knowledge of ICH-GCP, regional regulatory requirements, ethics committee processes and clinical trial legislation.
- Excellent organisational skills with a knack for managing competing priorities.
- A proactive, solutions-focused approach with a continuous improvement mindset.
- Strong communication and stakeholder-engagement skills.
- A genuine commitment to delivering high-quality work and supporting team success.
Benefits
- Various annual leave entitlements
- Health insurance offerings
- Competitive retirement planning offerings
- Global Employee Assistance Programme
- Life assurance
- Flexible country-specific optional benefits
