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Regulatory Affairs Specialist
2 months ago
We are seeking a highly skilled Regulatory Affairs Specialist to join our team at PharmaCare Laboratories. As a key member of our Regulatory Affairs team, you will be responsible for ensuring compliance with legal, statutory, industry, and corporate requirements related to the regulation of healthcare products in Australia and Asian markets.
Main Responsibilities- Regulatory Strategy Implementation: Implement agreed regulatory strategies efficiently and in line with business needs.
- Regulatory Support and Recommendations: Provide regulatory support and recommendations for the assessment and market access of new products, and/or existing product development.
- Regulatory Submissions: Prepare, submit, and track regulatory applications for a defined product portfolio of listed complementary medicines, registered medicines, medical devices, foods, cosmetics, and other FMCG products.
- Documentation and Compliance: Review and maintain documentation in the dossier compliant to regulatory requirements, identify deficiencies in product dossiers, and resolve any identified deficiencies in a solutions-oriented manner.
- Collaboration and Communication: Liaise with external agencies, suppliers, or others to ensure compliant product dossiers and facilitate evaluation, maintain adequate records and documentation of all regulatory and scientific affairs matters.
- Compliance and Quality Assurance: Ensure compliance of labelling and packaging to appropriate regulations and legislation, responsibility for the maintenance of databases related to regulatory activities.
- Team Collaboration: Work closely with local brand teams, Scientific Affairs, Quality Assurance, and Technical Services to manage responses to correspondence received from the Australian and/or Asian regulatory authorities and consultants.
- Post-Market Product Assessments: Contribute and assist in responding to post-market product assessments and audits from government agencies and regulators.
- Regulatory Updates and Compliance: Keep up to date with government legislation as it relates to regulatory affairs and provide support for submissions to government regulatory consultations and reforms.