Regulatory CMC Director, Development Strategy

argenx; Oost-Vlaanderen; On-site; EUR 100,000 - 138,000; Full time

Job summary

argenx is seeking a Regulatory CMC expert to lead global regulatory strategy for large molecule programs, from pre-clinical through commercial stages, in a rapidly expanding biotech environment.

You will author and review regulatory submissions, coordinate with internal teams and external partners, and ensure timely delivery while aligning with ICH, FDA, EMA requirements. English fluency required.

Qualifications

• Advanced degree in biotechnology, pharmaceutical sciences or bioengineering.
• Experience with CMC regulatory dossier development.
• Experience with large molecules is a plus.

Responsibilities

• Develop and implement regulatory strategies for pre-clinical to commercial programs.
• Prepare and manage CMC regulatory submission plans.
• Coordinate responses to Health Authorities and maintain timelines.
• Author and review CMC-related documents (IND/IMPD/MAAs/BLA) with stakeholders.
• Monitor regulatory commitments and risk mitigation.
• Collaborate with external partners across global locations.

Skills

Leadership

Team collaboration

Regulatory strategy

Documentation writing

Cross-functional coordination

Attention to detail

English fluency

Education

Master’s or PhD in biotechnology/pharmaceutical sciences/bioengineering

Tools

MS-Word

Job description

argenx is seeking a Regulatory CMC expert to lead global regulatory strategy for large molecule programs, from pre-clinical through commercial stages, in a rapidly expanding biotech environment.

You will author and review regulatory submissions, coordinate with internal teams and external partners, and ensure timely delivery while aligning with ICH, FDA, EMA requirements. English fluency required.