Description
Senior Regulatory Affairs Associates lead complex regulatory submissions and provide strategic guidance on compliance with Australian and international regulations.
Responsibilities
- Manage high-level regulatory submissions and product registrations.
- Provide advice on compliance with Australian regulatory standards.
- Mentor junior regulatory staff and review their work.
- Develop strategies to address regulatory challenges.
- Liaise with regulatory bodies such as the TGA and PBAC.
Qualifications
- Advanced degree or extensive experience in regulatory affairs.
- Strong knowledge of Australian regulatory frameworks.
- Proven leadership and mentoring abilities.
- Excellent communication and organisational skills.