Associate Director Regulatory CMC – Development

argenx SE; Oost-Vlaanderen; Sur place; EUR 100 000 - 138 000; Plein temps

Avantages offerts par ce poste

Incentive program

Résumé du poste

argenx SE is seeking a Regulatory CMC expert to lead regulatory strategies for pre-clinical, clinical, and commercial programs, coordinating with internal teams and external partners.

The role emphasizes preparing IND/IMPD/MAA submissions, assessing CMC risks, and contributing to lifecycle management, with strong leadership and cross‑functional collaboration required.

Qualifications

• Advanced degree with experience in CMC regulatory dossier development (IND/IMPD/BLA/MAA).
• Science-oriented, experience with large molecules is a plus.
• Strong writing skills and knowledge of ICH/FDA/EMA guidelines.

Responsabilités

• Develop and execute regulatory strategies for pre-clinical, clinical and commercial programs.
• Prepare and manage CMC submission plans (IND/IMPD/CTAs/MAAs).
• Coordinate responses to Health Authorities for timely submissions.
• Draft regulatory documents and briefing packages with internal/external stakeholders.
• Contribute to lifecycle management and regulatory risk strategies.
• Collaborate across global locations and external partners to maintain communication.

Connaissances

Team player

Leadership

Project management

Global collaboration

Organized

Attention to detail

Proactive

Fluent English

Formation

Master’s degree or PhD in biotechnology, pharmaceutical sciences or bioengineering

Description du poste

Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets, led by VYVGART, our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG, and with the potential to treat patients across dozens of severe autoimmune diseases. We are building a new kind of biotech company, one that maintains its roots as a science-based start-up and pushes our commitment to innovate across all corners of our business. We strive to inspire and grow our company, our partnerships, our science, and our people, because when we do, we deliver more for patients.

PURPOSE OF THE FUNCTION 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.

REPORTING LINE

Head of Global Regulatory CMC

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.

#LI-Onsite

The annual base salary hiring range for this position is €100,000.00 - €137,500.00 EUR

This job is eligible to participate in our short-term and long-term incentives program.

The hiring range displayed above is the range of possible base pay compensation that argenx believes in good faith it will pay for this role at the time of this posting.

The hiring range is based on the job grade for this position.

Individual compensation paid within this range depends on a variety of factors, including, but not limited to, internal equity, prior education and experience, job-related knowledge and demonstrated skills.

argenx may pay more or less than the posted range and this range may be modified in the future.

At argenx, all applicants are welcomed in an inclusive environment. They will receive equal consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other applicable legally protected characteristics.

argenx is proud to be an equal opportunity employer.

Before you submit your application, CV or any other personal details to us, please review our argenx Privacy Notice for Job Applicants to learn more about how argenx B.V. and its affiliates（“argenx”）will handle and protect your personal data. If you have any questions or you wish to exercise your privacy rights, please contact our Global Privacy Office by email at [e-mail].

argenx is a global immunology company dedicated to improving the lives of people suffering from severe autoimmune diseases. Through our rich pipeline of first-in-class therapies, led by VYVGART®, we are accelerating progress toward our bold 2030 vision: to reach 50,000 patients and transform the landscape of autoimmune treatment.

Our innovation mission combines with meaningful work and endless opportunities for growth to create once-in-a-career experiences.

argonauts work in locations around the globe including Belgium, Boston, Japan and Amsterdam.