Senior Regulatory Affairs Consultant

1 week ago


Australia Healthcare Professionals Group Full time
About the Opportunity

We are seeking a highly skilled Senior Consultant to join our Regulatory, Quality & Compliance team. As a Senior Consultant, you will be responsible for managing complex regulatory projects for clients in Australia, New Zealand, and the JAPAC region.

Key Responsibilities
  • Manage multiple client projects simultaneously, ensuring timely delivery and high-quality results.
  • Develop regulatory strategies and pathway options to meet client needs.
  • Prepare and review regulatory submissions, including literature-based applications, to ensure compliance with relevant regulations.
  • Liaise with clients and regulatory authorities to ensure effective communication and resolution of issues.
  • Mentor junior team members to develop their skills and knowledge.
  • Contribute to business development initiatives to identify new opportunities and grow the business.
  • Provide expert advice on regulatory affairs and compliance to clients and internal stakeholders.
  • Assist in responding to regulatory agency questions and supporting product lifecycle management activities.
Requirements
  • Degree in Science/Pharmacy or related discipline.
  • Minimum 8 years' experience in Australian/global regulatory affairs (Rx and biologicals preferred).
  • Strong knowledge of TGA/Medsafe regulations and guidelines.
  • Experience in clinical data evaluation and presentation of clinical and non-clinical data.
  • Confidence in handling challenges and finding solutions.
  • Commercial acumen and understanding of the broader healthcare environment.
About Our Company

Healthcare Professionals Group is a leading consultancy firm specializing in regulatory affairs, quality, and compliance for the healthcare and life sciences industries. We foster a supportive and friendly environment where people genuinely care about each other. We value work-life balance and offer a close-knit culture with hands-on support for new team members.



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