Description
Regulatory Affairs Associates ensure that products meet Australian regulatory standards by preparing and submitting applications and maintaining compliance throughout the product lifecycle.
Responsibilities
- Prepare and submit regulatory submissions to the TGA and other bodies.
- Ensure compliance with Australian and international regulatory guidelines.
- Review product labelling and documentation for accuracy.
- Monitor changes in Australian regulations and update processes accordingly.
- Collaborate with cross-functional teams to support product approvals.
Qualifications
- Bachelor’s degree in science, pharmacy, or related field.
- Knowledge of Australian regulatory requirements (e.g., TGA, PBAC).
- Strong analytical and problem-solving skills.
- Experience in regulatory roles is preferred.