Senior Regulatory Affairs Associate
A unique and exciting contract opportunity has become available in one of the world’s leading Biotechnology companies based in Sydney.
As the successful candidate will be responsible for helping to develop, implement and deliver regulatory strategies that will accelerate access to new products and optimise the value of the existing product portfolio. You will be the primary Contact with the Australian (TGA) and New Zealand (Medsafe) regulatory agencies. Furthermore you will be responsible for life cycle management support of the currently approved products to meet corporate and regulatory compliance requirements.
As this is a senior level position we are looking for candidates who possess the following attributes, communication skills and the ability to communicate cross-functionally, excellent attention to detail and accuracy high level of flexibility, team player, capable of being able to work autonomously.
- Collaboration with local and global stakeholders to develop optimum regulatory strategies to maximise business opportunities for both new product registration and ongoing life cycle management.
- Work with cross functional teams on new and existing product strategies
- Development of good working relationships with health authorities to support optimal business outcomes.
- Ability to support activities to influence the regulatory environment through contribution to industry groups and consultations to drive the strategic priorities. Operational excellence through use of necessary quality systems to meet corporate and regulatory compliance requirements for all regulatory activities in Australia.
- Minimum of 3 years’ experience in in Regulatory Affairs
- A successful background in achieving regulatory approvals and supporting successful launches in Australia
- Experience in dealing with a broad range of stakeholders at all levels internal and external to the company.
- Demonstrated strong relationship and history of successful interactions with TGA and Medsafe
- Experience in the review, critical evaluation and presentation of clinical data.
- High level of knowledge of TGA legislation, regulations, guidelines and working procedures
Minimum a relevant Pharmacy/Bioscience degree and a higher degree desirable
This is a rewarding opportunity for an individual who wants to be part of an organisation which invests in transformative medicine to change people’s lives!
Please reach out if you require further information.