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Regulatory Affairs Specialist

2 months ago


Warriewood, New South Wales, Australia PharmaCare Full time
About Us

PharmaCare is a leading Australian-owned and family-operated business, proud of its heritage and commitment to delivering high-quality products to the market. With a diverse portfolio of well-known brands, we strive to inspire people to be their best, healthiest, and happiest selves.

Job Summary

We are seeking a highly skilled Regulatory Affairs Associate to join our team, responsible for ensuring compliance with legal, statutory, industry, and corporate requirements related to the regulation of healthcare products in Australia and Asian markets.

Key Responsibilities
  • Implement regulatory strategies to ensure compliance with business needs
  • Provide regulatory support and recommendations for product assessment and market access
  • Prepare, submit, and track regulatory applications for product portfolios
  • Review and maintain documentation in compliance with regulatory requirements
  • Liaise with external agencies and suppliers to ensure compliant product dossiers
  • Maintain records and documentation of regulatory and scientific affairs matters
  • Ensure compliance with labelling and packaging regulations
  • Manage databases related to regulatory activities
  • Work closely with local brand teams and other departments to manage regulatory correspondence
Requirements
  • Experience in regulatory affairs, preferably in OTC registered medicines, listed medicines, food, cosmetics, medical devices, and/or other related products
  • Science-based degree or postgraduate qualification
  • Self-driven, results-oriented individual with a positive outlook and attention to detail
  • Strong analytical and problem-solving skills
  • Commitment to compliance
About You

We are looking for a motivated and detail-oriented individual who is passionate about regulatory affairs and committed to delivering high-quality outcomes. If you have a science-based background and experience in regulatory affairs, we encourage you to apply for this exciting opportunity.