Vaxxas is a fast growing and scale-up stage biotech company developing a novel vaccine delivery system that safely and cost effectively amplifies vaccine efficacy. It is an advanced platform that vaccinates by applying a patch to the skin for a few seconds directly depositing vaccine amongst dense population of key immune cells.
Reporting to the Chief Development and Operations Officer, the Head of Regulatory Affairs will be responsible for all Regulatory Affairs activities within Vaxxas. The person selected for this newly created position, will need to develop and execute the regulatory strategy for the development of Vaxxas products, build a regulatory team and lead interactions with global regulatory agencies. The successful applicant will need to be able to communicate the regulatory expectations to development teams and external stakeholders and prepare regulatory strategies and submissions.
From an operational and delivery perspective, the Head of Regulatory Affairs will:
- Manage the preparation of all regulatory submissions and ensure that all submissions are of high and acceptable standard.
- Understand and be able to communicate to team members and other stakeholders the current international regulatory requirements for Vaxxas products.
- Serve as primary regulatory agency contact (at the FDA and at other agencies) to achieve company regulatory objectives, by fostering strong relationships and acting as a credible, reputable, and effective advocate for the company.
- Build a stage-appropriate regulatory affairs team and select and manage external consultants. Develop regulatory strategies, objectives, operational plans and implement the plans to achieve the company objectives.
To be successful in this role you will have experience as the Head of Regulatory Affairs within a similar company. You will have experience across the following:
- A Scientific degree in an appropriate discipline.
- Regulatory Affairs Certification (RAC) desirable.
- Experience in regulatory affairs (US,EMEA and Australia) within the pharmaceutical industry including the development of vaccines or biological products and experience with medical devices and/or combination biologic/medical devices.
- Experience in managing a regulatory affairs team or building a regulatory affairs department and in managing/working with consultants and external advisors.
- Experience working with development teams and providing advice on the regulatory agency expectations and requirements.
- Strong leadership and communication skills, to ensure that sound drug development, regulatory and compliance practices are fully integrated into product development and clinical activities.
- Ability to explain the regulatory guidelines/guidance in a way that the development teams and management understand the requirements and the ability to work with development teams and management to reach results which will meet the regulatory expectations.
- An entrepreneurial, innovative, energetic, hands-on, team oriented, and customer focused, attitude and approach.
- Ability and strong desire to work in a dynamic “scale-up” environment and be able travel from time to time domestically and/or internationally.
- Exceptional interpersonal and leadership skills to effectively communicate and build working relationships with a broad spectrum of audiences at all organizational levels.
- Commitment to achieving corporate objectives while maintaining the highest ethical, regulatory, and scientific standards.
If you are excited by the prospect of the challenges and enjoy rolling up your sleeves, we want to hear from you.
To be considered, please submit your resume and cover letter (outlining your core capability for the role, demonstrated experience of how you have delivered outcomes and why this role is of interest) both in Word format by selecting the “apply now” function.
Confidential enquiries can be made to Peter Starling, Senior Client Partner on 07 3305 5830 or 0433 422 518.