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Regulatory Affairs Specialist
3 weeks ago
BioMedica is a quality-focused Australian company dedicated to natural medicine products.
We support holistic practitioners through our services.
The Regulatory Affairs and R&D Manager will lead the regulatory team to ensure product registration approvals, market access, and business growth through strategic planning and compliance.
- Manage the team for product registration approvals and market access opportunities.
- Drive partnerships with various divisions.
- Develop creative regulatory strategies to meet business needs.
- Provide evaluations for new and existing products.
- Prepare and submit applications for listed medicines, registered medicines, medical devices, and other products.
- Ensure dossier compliance to regulatory requirements.
- Liaise with internal teams to develop new products.
- Use problem-solving skills to resolve deficiencies or issues.
The ideal candidate will be a qualified naturopath or have equivalent experience in natural health medicines.
Key attributes: self-driven, results-oriented, strong analytical skills, excellent communication, proven experience organizing others, strategic thinker, and understanding of relevant areas.
Key Requirements:
- A degree in naturopathy or related field.
- Proven experience in regulatory affairs and research and development.
- Excellent communication and organizational skills.
- Ability to work independently and as part of a team.
- Familiarity with regulatory requirements and standards.