CMC Regulatory Director & FSP Lead

ThermoFisher Scientific; Brussel Hoofdstad; On-site; EUR 180,000 - 240,000; Full time

Job summary

Thermo Fisher Scientific in Brussels is seeking an experienced Director, Regulatory affairs — CMC FSP to lead regulatory services for global clients, blending technical CMC expertise with delivery leadership.

You will guide senior teams, shape regulatory strategy across development, registration, and lifecycle management, and ensure timely, compliant submissions. The role offers strategic influence and cross‑functional collaboration within a high‑performing FSP.

Qualifications

• Bachelor’s degree required.
• 12+ years in regulatory affairs.
• 5+ years in management.

Responsibilities

• Lead, coach, and develop staff with performance reviews.
• Provide CMC regulatory strategies and project oversight.
• Serve as executive client contact for regulatory matters.
• Oversee budgeting, forecasting, and resource planning.
• Collaborate with business development on new opportunities.

Skills

Leadership

Regulatory affairs

CMC regulatory knowledge

Client management

Budgeting & forecasting

Team development

English communication

Education

Bachelor’s degree

Tools

Microsoft Word

Microsoft Excel

Adobe Acrobat

Job description

Thermo Fisher Scientific in Brussels is seeking an experienced Director, Regulatory affairs — CMC FSP to lead regulatory services for global clients, blending technical CMC expertise with delivery leadership.

You will guide senior teams, shape regulatory strategy across development, registration, and lifecycle management, and ensure timely, compliant submissions. The role offers strategic influence and cross‑functional collaboration within a high‑performing FSP.