Company

Australia Biotechnology ManufacturingSee more

addressAddressKeysborough, VIC
CategoryLegal

Job description

  • 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
Refer code: 2241880. Australia Biotechnology Manufacturing - The previous day - 2024-05-23 00:20

Australia Biotechnology Manufacturing

Keysborough, VIC
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