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Regulatory Affairs Specialist

1 week ago

Sydney, New South Wales, Australia PharmaCare Group Full time

BioMedica is a natural health company dedicated to serving the needs of practitioners in clinical practice. As part of the PharmaCare Group, we have created a product range and support structure to cater to the professional holistic practitioner. Our team is passionate about quality wellness products and education.

Job Overview

About the role

  • We are seeking a highly motivated individual to manage and support our Regulatory and NPD team in achieving product registration approvals and market access opportunities.
  • The ideal candidate will drive business partnerships with various divisions of the business, ensuring creative and robust regulatory strategies are developed and delivered efficiently.
  • This role requires providing and overseeing regulatory evaluation of new products and existing product development to enable efficient market access.
Key Responsibilities

Manage Regulatory Applications: 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.

Develop Regulatory Strategies: Create and maintain all products dossier compliance to regulatory requirements, including dossier management improvements and efficiencies.

Liaise with NPD Team: Collaborate with internal NPD project teams to support their development and delivery of new products.

Resolve Deficiencies: Use problem-solving and collaboration to resolve any identified deficiencies or regulatory issues in a solutions-oriented manner.