Regulatory Affairs Director
4 weeks ago
Job Summary
This is a unique opportunity to lead a growing business from a regulatory affairs perspective with multiple launches and a dynamic & entrepreneurial team. As the Head of Regulatory Affairs, you will be responsible for managing the submission process and working closely with health authorities TGA and Medsafe and SEA stakeholders.
Key Responsibilities
- Leading the review, interpretation, development and submission of technical files and regulatory dossiers
- Providing input on possible new ways of drug development and registration and work on proposals for business development
- Managing and maintaining all regulatory registrations in accordance with the latest standards
- Working cross-functionally with marketing and sales team as part of the leadership team
- Supporting, growing and developing the Regulatory Affairs team
- Overseeing other related areas and functions to ensure all Adverse Events, product and/or quality complaints are appropriately addressed and processed
Requirements
- Tertiary scientific qualification Life Sciences
- An extensive track record in efficient submissions biologicals & orphan drugs
- Strong strategic & executional expertise across multiple launches
- External stakeholder management
- Exposure to APAC markets will be advantageous
- Strong presentation & relationship building skills
- Excellent organisational skills & attention to detail
About Us
We are a dynamic and mature team in a hands-on role where your experience and expertise will play a large contribution to the wider business. This is a truly exciting opportunity to make your impact in a specialty therapeutic area with a fast growing business.
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