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Regulatory Affairs Specialist

2 months ago

Northern Beaches Council, Australia PharmaCare Laboratories Full time

About the Role:

As a key member of the Regulatory Affairs team at PharmaCare Laboratories, you will play a critical role in ensuring the compliance of our products with legal, statutory, industry, and corporate requirements related to the regulation of healthcare products in Australia and Asian markets.

Key Responsibilities:

  • Implementing agreed regulatory strategies efficiently and in line with business needs
  • Providing regulatory support and recommendations for the assessment and market access of new products, and/or existing product development
  • Preparing, submitting, and tracking regulatory applications for a defined product portfolio of listed complementary medicines, registered medicines, medical devices, foods, cosmetics, and other FMCG products
  • Reviewing and maintaining documentation in the dossier compliant to regulatory requirements
  • Liaising with external agencies, suppliers, or others to ensure compliant product dossiers and facilitate evaluation
  • Maintaining adequate records and documentation of all regulatory and scientific affairs matters, including documenting and following change control procedures
  • Ensuring compliance of labelling and packaging to appropriate regulations and legislation
  • Responsibility for the maintenance of databases related to regulatory activities
  • Working 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

About You:

We are seeking an experienced and skilled Regulatory Affairs professional who possesses a science-based degree or postgraduate qualification and has subject matter expertise in regulatory affairs. You will be self-driven, results-oriented, with a positive outlook, and a clear focus on high-quality outcomes. You will be able to work with minimal supervision, with exceptional planning skills, prioritizing work requirements to meet deadlines in a fast-paced environment, while maintaining a strong attention to detail.