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Regulatory Affairs Specialist
2 weeks ago
Job Title: Regulatory Affairs Specialist
About the Role:- We are seeking a highly skilled Regulatory Affairs Specialist to join our team.
- The ideal candidate will have experience in preparing, reviewing, and submitting regulatory dossiers to Medsafe and TGA.
- Responsibilities include ensuring compliance with regulatory frameworks and guidance.
- As the regulatory project coordinator for assigned submissions, you will serve as a liaison between teams.
- Lifecycle management of prescription medicines is also a key aspect of this role.
- Other duties include responding to agency queries and deficiency letters.
- Maintaining internal regulatory trackers and databases is also required.
- A bachelor's degree in science, pharmacy, or a related discipline is essential.
- Minimum 5 years' experience in regulatory affairs is preferred.
- Good knowledge of legislation, regulations, guidelines, and working procedures is necessary.
- High-level written and oral communication skills are crucial.
- Proven problem-solving and project management skills are required.
- Reasonable computer literacy is expected.
- Collaborate with experts in regulatory affairs.
- Contribute to projects that impact patient care.
- Enjoy a flexible work model and commitment to work-life balance.