Senior Regulatory Affairs Consultant
1 week ago
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.
- 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.
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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