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Strategic Regulatory Affairs Manager

3 weeks ago

Sydney, New South Wales, Australia beBeeRegulatory Full time $100,000 - $120,000
Job Title: Strategic Regulatory Affairs Manager

About the Role

The successful candidate will lead and support our regulatory and new product development team to ensure product registration approvals and market access, enabling business growth through strategic regulatory planning and compliance.


Key Responsibilities:
  • Manage and support the regulatory and NPD team to achieve product registration approvals/market access opportunities to allow business growth.
  • Drive business partnerships with various divisions of the organization.
  • Ensure creative and robust regulatory strategies are developed and delivered efficiently and in line with business needs.
  • Provide and oversee regulatory evaluation of new products, and/or existing product development (e.g. regulatory classifications) to enable efficient market access.
  • Manage preparation, submission and tracking of regulatory applications for a defined product portfolio of listed complementary medicines, registered medicines, medical devices, foods, cosmetics, and other FMCG products.
  • Develop and maintain all products dossier compliance to regulatory requirements, including dossier management improvements and efficiencies.
  • Liaise with internal NPD project team to support their development and delivery of new products.
  • Use problem solving and collaboration to resolve any identified deficiencies or regulatory issues in a solutions-oriented manner, working closely with scientific affairs, quality assurance, technical services, and local brand teams.
  • Develop new products to capture market opportunities and increase our market reach.
  • Support the development of regulatory policy priorities, company positions and stakeholder engagement plans.
  • Oversee and manage record keeping and documentation of all regulatory and scientific affairs matters, including documenting and following change control procedures.
  • Manage responses to correspondence received from the Australian regulatory authorities (e.g. TGA, FSANZ, etc) within an agreed priority and timeframe.
  • Maintain strong relationships with external agencies, suppliers or others.
  • Keep up-to-date with government legislation as it relates to regulatory affairs, with appropriate communication of (potential) impacts across the business.
  • Keep up to date with new raw material expansion, clinical research, ATRG listing.