Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is a late-stage biopharmaceutical company that is creating and developing a pipeline of differentiated antibody therapeutics.
Requirements
- Develop, plan and execute appropriate regulatory strategies of pre-clinical, clinical (early to late stage), and commercial stage programs
- Responsible for preparing and managing CMC regulatory submissions
- Coordinate, write and review responses to regional and global Health Authorities
- Participate to the authoring and preparing IND, IMPD, scientific briefing documents, Investigator Brochures and regulatory agency response documents
- Participate to the authoring and preparing BLA, J-MAA, MAA and ROW applications and related life cycle documents
- Coordinating activities with external partners
- Conduct regulatory assessments for CMC change controls and oversee submission of amendments for clinical phases
- Tracking execution of regulatory Commitments
Benefits
- Competitive salary package
- Extensive benefits
- Front seat in the development of therapeutic antibodies
- Work environment in a human-sized, dynamic and rapidly growing biotech company