Health and Safety Compliance Specialist

1 week ago

Sydney, New South Wales, Australia beBeeRegulatory Full time $80,000 - $140,000

About Regulatory Affairs Roles

We are looking for a detail-oriented individual who is passionate about regulatory affairs and has a strong understanding of the industry.

This role requires a dedicated and proactive person to support the regulatory management of health-related products in Australia and other countries within Asia Pacific Regions.

Key Responsibilities:

  • Develop and maintain product regulatory dossiers, ensuring accuracy and compliance with various regulations and codes of practice.
  • Conduct thorough reviews of product formulations against market requirements and relevant regulations.
  • Create and ensure accuracy of product labelling templates.
  • Review and approve product labelling, ensuring due diligence and sponsor obligations are met.
  • Manage regional regulatory strategies to smooth product market access compliance.
  • Review and approve marketing materials, guaranteeing alignment with regulatory standards.
  • Contribute to the development, implementation, and maintenance of regulatory SOPs, procedures, and data management.
  • Support post-marketing surveillance and adverse event reporting/analysis per regulation.
  • Review safety data and perform safety assessments as required per regional regulation.
  • Collaborate with multifunctional teams regionally to facilitate product development and sales.

Required Skills and Qualifications:

  • Bachelor's/Master's Degree in health-related science, life science, pharmacy, or medical degree.
  • Solid experience in similar field/job function for 5+ years in multinational companies.
  • China Cross Border E-Commerce experience will be an advantage.
  • Proactive, self-motivated, and well-organized individual.
  • Ability to work independently and as part of a team.
  • Multitasking and problem-solving attitudes with strong attention to details.
  • Strong influencing skills, previous experience of influencing Ministry of Health is desirable.
  • Basic understanding of technical regulation (testing and specification) and GMP, GVP & GCP.
  • Excellent communication, interpersonal, and presentation skills, both in spoken and written English and Mandarin.
  • Other language skills will be an advantage.
  • Strong professional integrity.
  • Ability to assess and provide risk assessment/mitigation plans based on regulations and communicate to the business.
  • Ability to prioritize and organize in an ever-changing environment while under pressure.

About You

This role requires a dedicated and detail-oriented individual who is passionate about regulatory affairs and has a strong understanding of the industry.

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