Address- Listing of the new Products
- Variations including labelling changes, safety updates.
- Maintenance of Marketing Authorisations including renewals
- Deficiency responses to authorities
- GMP Clearances
- TGO 91 and 92
- Interfacing with regulatory authorities to facilitate the approval of submissions.
- Work with sites (manufacturing, PV service provider) / appropriate personnel/departments to ensure regulatory requirements are met and resolve any outstanding regulatory issues.
- Partner with Quality Management for site transfers including but not limited to managing the transfer of registered information, checking master batch/analytical/labelling information and initiating change controls when required.
- Documenting all regulatory related change controls and participating in the overall process in the organisation as and when required
- Participating in Product Quality Reviews
- Participate in internal and external audits of the facilities and suppliers.
- Liaise with regulatory authorities for advice and guidance when necessary and to resolve issues to achieve the best possible outcome for the business.
- Maintain up-to-date records and documentation in relation to Marketing Authorisations
- Carry out duties in line with regulatory, commercial, quality and business needs and ensuring compliance with regulatory legislation and guidelines, and company processes and procedures.
- Support other regulatory employees within the Company when necessary.
- Assist in preparation of procedures (SOPs) for relevant regulatory activities, and in preparation and review of procedures for other areas.
Skills, Competencies and Experience
- Minimum of at least 3-5 years of Regulatory Affairs Experience with current TGA&Medsafe requirements for Complementary medicine.
- Tertiary qualification in science, or relevant discipline
- Excellent knowledge of GMP, ISO, GDP/GWP/GLP standards as per current PIC/S
- Detailed & effective communication skills that will be understood by all key stakeholders and partners.
- Strong Project Management skills
- Strong attention to detail and task accuracy
- Ability to act independently on given tasks and be a good team player.
- Very high attention to detail with ability to problem solve.
- Friendly with a good work ethic and the ability to work independently and within a small team
- Listing of the new Products
- Variations including labelling changes, safety updates.
- Maintenance of Marketing Authorisations including renewals
- Deficiency responses to authorities
- GMP Clearances
- TGO 91 and 92
- Interfacing with regulatory authorities to facilitate the approval of submissions.
- Work with sites (manufacturing, PV service provider) / appropriate personnel/departments to ensure regulatory requirements are met and resolve any outstanding regulatory issues.
- Partner with Quality Management for site transfers including but not limited to managing the transfer of registered information, checking master batch/analytical/labelling information and initiating change controls when required.
- Documenting all regulatory related change controls and participating in the overall process in the organisation as and when required
- Participating in Product Quality Reviews
- Participate in internal and external audits of the facilities and suppliers.
- Liaise with regulatory authorities for advice and guidance when necessary and to resolve issues to achieve the best possible outcome for the business.
- Maintain up-to-date records and documentation in relation to Marketing Authorisations
- Carry out duties in line with regulatory, commercial, quality and business needs and ensuring compliance with regulatory legislation and guidelines, and company processes and procedures.
- Support other regulatory employees within the Company when necessary.
- Assist in preparation of procedures (SOPs) for relevant regulatory activities, and in preparation and review of procedures for other areas.
Skills, Competencies and Experience
- Minimum of at least 3-5 years of Regulatory Affairs Experience with current TGA&Medsafe requirements for Complementary medicine.
- Tertiary qualification in science, or relevant discipline
- Excellent knowledge of GMP, ISO, GDP/GWP/GLP standards as per current PIC/S
- Detailed & effective communication skills that will be understood by all key stakeholders and partners.
- Strong Project Management skills
- Strong attention to detail and task accuracy
- Ability to act independently on given tasks and be a good team player.
- Very high attention to detail with ability to problem solve.
- Friendly with a good work ethic and the ability to work independently and within a small team
