Associate Director Regulatory CMC - Development

Associate Director Regulatory CMC - Development

argenx

Ghent, Belgium

ROLES AND RESPONSIBILITIES

• Develop, plan and execute appropriate regulatory strategies of pre-clinical, clinical, and commercial stage programs in close collaboration with the regulatory sub-functions, quality and CMC team members.
• Responsible for preparing and managing CMC regulatory submission plans (including IND/IMPD/CTAs/MAAs), ensuring submissions are accurate, complete, and timely in accordance with regulations and procedures.
• Coordinate, write and review responses to regional and global Health Authorities to ensure timely submission.
• Participate to the authoring and preparing IND, IMPD, scientific briefing documents, Investigator Brochures and regulatory agency response documents for therapeutic compounds in development in close collaboration with external and internal stakeholders.
• Participate to the authoring and preparing BLA, J-MAA, MAA and ROW applications (module 2 and 3) and related life cycle documents.
• Coordinating activities with external partners ensuring that deliverables are executed with the right priorities and to the required standards and maintain open lines of communication on assigned projects/products to ensure awareness on status and issues relating to submissions.
• Providing strategic input into CMC risks assessment and mitigation plans and ensuring they remain in line with the overall global Regulatory CMC strategy.
• Conduct regulatory assessments for CMC change controls and oversee submission of amendments for clinical phases.
• Tracking execution of regulatory commitments.

SKILLS AND COMPETENCIES

• Team player; able to build effective relationships with internal and external stakeholders.
• Leadership and communication skills.
• Experience in operations, planning, project management, and tracking projects with high complexity and risk, including clearly defined critical paths.
• Experience managing projects across global locations and time zones, as well as working effectively in diverse cultural and international environments.
• Well organized and able to handle multiple assignments in parallel.
• Excellent writing skills coupled with comprehensive knowledge of pharmacopoeial requirements, ICH guidelines, FDA and EMA/CHMP regulations and guidelines, and other international regulatory requirements.
• Proficiency with MS-Word and preferably with document management systems.
• Eye for detail and quality conscious attitude.
• Proactive – can do mentality.
• Fluent in English – our working language.

EDUCATION, EXPERIENCE AND QUALIFICATIONS

• Master’s degree or PhD in biotechnology, pharmaceutical sciences or bioengineering, with relevant expertise in CMC development and CMC regulatory dossier development (IND/IMPD/BLA/MAA).
• Science oriented, experience with large molecules is a plus.