Manager Regulatory CMC

Manager Regulatory CMC

argenx

Ghent, Belgium

Purpose of the function

The Manager Regulatory CMC is responsible for providing Regulatory CMC expertise into the development and implementation of the global regulatory strategy, operations and planning for the CMC aspects of assigned projects/products. Responsibilities include developing and implementing regulatory strategies, authoring/reviewing of quality submission packages, ensuring their accuracy and timely delivery, and coordinating responses to health authorities for the company’s large molecule therapeutic drug candidates throughout their clinical development towards marketing approval as well as global life cycle management projects. Additionally, the job requires strong communication and coordination with external partners, contributing to risk assessments and mitigation strategies. In this role you will have a front seat in the heart of a development/commercial organization and able to weigh into CMC development strategies. Demonstrates strong leadership, effective cross-functional collaboration, and excellent communication skills.

Roles & Responsibilities

• Develop, plan and execute appropriate regulatory strategies of pre-clinical, clinical (early to late stage), and commercial stage programs in close collaboration with the regulatory sub-functions, quality and CMC team members;
• Responsible for preparing and managing CMC regulatory submissions (including IND/IMPD/CTAs), 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 & 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;
• 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 monoclonal antibodies is a plus. Excellent writing skills coupled with comprehensive knowledge of pharmacopoeia requirements, ICH guidelines, FDA and EMA/CHMP regulations and guidelines, and other international regulatory requirements.