AstriVax is a privately held spin-off company from the KU Leuven, founded mid 2022 with a seed round of €30 million to bring our ambition to the next level. We are building a first in class Plug & Play vaccine platform with a patented DNA based technology that launches self-amplifying live attenuated viruses on which additional targets can be added. The versatile technology of AstriVax can be used to develop a wide range of vaccines to prevent and treat infectious diseases, up to potential applications in oncology. We aim to address major challenges in vaccinology by developing novel vaccines that are single dose (game changing in vaccine landscape), easy to produce and with reduced cold chain requirements. The live attenuated viruses being launched from our products induce a polyfunctional immune response which has the potential to address many unmet medical need targets.
We are currently hiring a Regulatory Affairs (RA) Lead
As RA Lead you are responsible to define the global regulatory strategy of the Plasmid Launched Live Attenuated Virus (PLLAV) platform and you will execute the overall RA activities and deliverables of the company’s PLLAV platform. Your main responsibilities will encompass:
- Being the main contact with regulatory agencies globally.
- Defining strategy for regulatory consultations globally.
- Writing regulatory documents, like e.g. parts of the CTA (IMPD, etc) or IND sections, briefing books for regulatory consultations, etc.
- Contribute to review of other documents included in regulatory submissions (e.g. IB, DSUR, etc).
- Coordinating the submissions to regulatory authorities worldwide, including being the champion of regulatory submission platforms.
- Performing regulatory intelligence.
- Being part of the project teams and provide regulatory input in the strategy, ensuring that development activities are state-of-the-art and meet the stage-specific regulatory requirements.
- Practical/active execution of the daily activities for the listed responsibilities.
- Be the main point-of-contact for regulatory contractors.
- Master or PhD degree in life sciences or equivalent working experience.
- At least 8 years of practical RA experience in the pharmaceutical or biologicals industry, experience in vaccines and/or nucleic acid technologies is a plus.
- Excellent understanding of the regulatory landscape, the vaccine development process, both from a procedural, clinical as well as manufacturing and analytical side.
- Strong track record in preparing RA documentation and submissions to the regulatory authorities.
- Excellent writing and communication skills.
- Strong sense for detail, open and critical mind, high quality standards.
- Good leadership skills, able to listen, to negotiate, to decide.
- A real collaborative Team player with a hands-on can do and solution-oriented attitude.
WHAT DO WE OFFER
A stimulating, open and collaborative environment where every employee can make an impact. We believe that we can only achieve our goal if we work together. You’ll be part of a passionate and inspiring team that goes the extra mile to address major challenges in vaccinology. We foster a culture of learning, entrepreneurship and innovation. Together we build the company.
Are you in for this new professional challenge? Pease send your CV to email@example.com, we welcome your talent!