Regulatory Affairs Manager - CMC Analytics Lead

ThermoFisher Scientific; Brussel Hoofdstad; Sur place; EUR 80 000 - 110 000; Plein temps

Résumé du poste

Thermo Fisher Scientific in Belgium is seeking a Regulatory Affairs Manager to provide strategic regulatory leadership across regional product development from preclinical stages through registration and lifecycle optimization. You will deliver regulatory intelligence, author submission modules, coordinate with CMC and QA teams, ensure compliance with ICH/GMP, and interface with clients to accelerate approvals.

Fluent English required; occasional international travel may be required.

Qualifications

• Master in chemistry, pharmaceutical sciences, bio-engineering, or related discipline.
• Fluent in English, written and spoken.

Responsabilités

• Follow up on regulatory activities across regions and support submissions.
• Provide strategic regulatory guidance and intelligence for product development.
• Coordinate with CMC, QA and manufacturing teams to ensure compliance and timely regulatory deliverables.
• Author and review regulatory documents and submission components for global filings.
• Support lifecycle management and post-approval variations.

Connaissances

Regulatory leadership

Regulatory intelligence

Project management

GMP/ICH knowledge

English fluent

Formation

Master in Chemistry/Pharmaceutical Sciences

Description du poste

Thermo Fisher Scientific in Belgium is seeking a Regulatory Affairs Manager to provide strategic regulatory leadership across regional product development from preclinical stages through registration and lifecycle optimization. You will deliver regulatory intelligence, author submission modules, coordinate with CMC and QA teams, ensure compliance with ICH/GMP, and interface with clients to accelerate approvals.

Fluent English required; occasional international travel may be required.