Unique opportunity to lead a growing business from a regulatory affairs perspective with multiple launches and a dynamic & entrepreneurial team!

• Newly created senior leadership opportunity MEL based!
• Strategic & operational responsibility. Highly agile environment.
• Partner with CEO & highly experienced APAC exec who challenge the status quo

We are excited to be partnering with this international biopharmaceutical company dedicated to providing new and innovative therapies and technologies that fulfil unique unmet needs in our community. As leaders in the commercialisation of products across various therapeutic areas, they have established a strong reputation for successfully promoting partner products in ANZ and SEA. With a steadfast commitment to patient care and delivering value to customers, they foster a culture of innovation and entrepreneurship. Their efforts are driven by solid clinical evidence, close customer partnerships, and exceptional service.

Reporting to the CEO your responsibilities will include:

• Managing the submission process and working closely with health authorities TGA and Medsafe and SEA stakeholders.
• 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

To be successful in this role you will have:

• 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

Candidates with a background on biologicals and orphan drugs will be highly regarded. What is also important is that you enjoy working with 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.
To apply for this role please submit your application in WORD format by clicking 'apply'; or contact Jasmine Garbino on 0460 947 804 for further queries.  Confidentiality is assured.