Senior Regulatory Affairs Associate (BBBH36124) Inner Suburbs Melbourne, Australia
About the company
With the highest professional and ethical standards, this leading pharma company seeks to commercialise therapies and technologies that uniquely fulfil the unmet medical needs in the Australian community.
About the opportunity
Working on predominantly oncology/haematology submissions and reporting to a highly experienced Regulatory Manager your main responsibility will be to ensure regulatory compliance of the prescription product portfolio. As a Senior Regulatory Affairs Associate you will work autonomously and will come with broad understanding of the regulatory requirements of the pharmaceutical product life cycle.
Duties
- Plan and manage regulatory activities for Australia and New Zealand relating to assigned projects that span technical areas including clinical, non-clinical, and CMC.
- Assist in developing and implementing strategies of regulatory submissions
- Manage the preparation, review, and timely submission of all components of regulatory dossiers as required for investigation and registration of products
- Ensure regulatory submissions are maintained in compliance with ANZ regulatory requirements.
- Provide expertise on regulatory matters.
- Develop and maintain current regulatory knowledge and advise management of significant developments.
- Support the Quality manager with a variety of quality duties
Skills and Experience
- Minimum of 3 years regulatory affairs experience working with pharmaceuticals
- Understanding of TGA and Medsafe regulatory requirements
- NCE & Cat 1 experience required
- Detail-oriented, a self-starter, and be comfortable with broad responsibilities in an entrepreneurial, fast-paced, small company environment
- Effective verbal and written communication skills are a must as well as superior planning skills
Culture
Strong work ethic, determined, dedicated, and driven to achieve targets. Transparent and honest working together to meet common goals. Collaborative and autonomous and a highly professional and cross functional teams.
How to Apply
Click apply or contact Jo Turner, Senior Specialist Manager, on 03 9938 7120 for a confidential discussion.