Regulatory Affairs Specialist
4 weeks 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- Develop and implement regulatory strategies and pathways for clients
- Prepare and review regulatory submissions, including literature-based applications
- Liaise with clients and regulatory authorities to ensure compliance
- Mentor junior team members to develop their skills and expertise
- Contribute to business development initiatives to drive growth and revenue
- Provide expert advice on regulatory affairs and compliance to clients
- 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
- 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.
We are committed to delivering exceptional results and building long-term relationships with our clients. If you are a motivated and experienced professional looking for a new challenge, we encourage you to apply for this exciting opportunity.
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