Manager Regulatory CMC

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