As an (Associate) Director Regulatory 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
Working at LAVA
LAVA Therapeutics offers an attractive set of labour conditions, recognizing and rewarding its 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.
Our Core Values
Our company culture is built on five important Core Values: Innovation, Teamwork, Results-orientation, Flexibility and Fun. We understand that innovation is at the heart of what we do. We drive the ability to innovate and we all have a strong awareness about emerging scientific and business opportunities. We work closely as a team, have a constructive and collaborative mindset and we put the common interest of the company above our own individual interest. We have a strong orientation on results, we meet agreed goals in a timely and efficient manner and we deliver on our promises. We are flexible, adapt well to changing circumstances and work well under pressure. Finally, we all contribute to a safe, professional and enjoyable workplace in which people are treated respectfully and diversity is embraced.
How to apply
Please send your CV together with a cover letter to email@example.com referring to the (Associate) Director Regulatory CMC (non-clinical) vacancy.
Your application and related information will remain strictly confidential.