LAVA seeks a new team member:
Regulatory Affairs Manager (CMC/non-clinical)
Lava Therapeutics (LAVA) is a start-up company that creates and develops next generation γδ T cell engaging bispecific antibodies for the curative treatment of cancer.
LAVA started its operations in 2017 and is advancing its proprietary platform and pipeline of bispecific therapeutic antibodies, building on cutting-edge research originating from Dr. Hans van der Vliet’s group at the VU University Medical Center and Cancer Center Amsterdam. In 2018, LAVA raised EUR 16 million in its first major institutional financing round that will allow LAVA to develop a lead candidate for clinical testing and broaden its pipeline and bispecific γδ T cell engager platform. In the coming two years, two compounds will be brought to the clinic. Expanding our team with new, talented, employees is key to LAVA’s future success. The company is based in Utrecht, The Netherlands.
LAVA offers an attractive set of labor conditions, recognizing and rewarding its highly talented and motivated employees. This includes the ability to work together with a group of highly experienced leaders and professionals who all have a track-record of success in their field of business and in Life Science industry, we offer flexible working hours, a premium-free pension plan, 30 paid vacation days, opportunities for growth and development and a professional working environment in which hard working is balanced with fun.
As a Regulatory Affairs Manager (CMC/non-clinical) in the development team you will:
- Have up-to-date knowledge on regulatory guidelines on New Biological Entities and share this with R&D Team
- Prepare regulatory submissions including CTD, IMPD, CTA and IND and documents for regulatory agencies in US, EU and ROW with a focus on CMC. Ideally you also have knowledge of non-clinical development
- Connect with (inter)national health authorities, conduct agency meetings and prepare contact reports and meeting minutes
- Provide input in the development programs on the regulatory strategy needed for successful phase 1 and phase 2 submissions of new biological drugs
- Be responsible for setting up a document management system to support/facilitate CTD authoring and corresponding filings
- Assemble and maintain product development information repository to allow efficient retrieval of development reports, protocols, specifications, and other relevant documentation
- Represent LAVA’s interest in internal and external meetings
- Review development reports for regulatory compliance
- MSc or PhD in biotechnology, biology or related sciences
- > 5 Years of relevant regulatory experience in the (bio)pharmaceutical industry
- Medical/scientific writing skills is an asset
- Excellent project management skills
- Flexible mindset and resistance to stress and changes in strategy
- Outstanding written and verbal communication skills in Dutch and English
- Able to travel based on business needs
- A competitive salary package with benefits
- A work environment in a dynamic and innovative biotech company
How to apply
Please send your CV together with a cover letter to email@example.com referring to the Regulatory Affairs Manager vacancy.
Your application and related information will remain strictly confidential.