Country Submissions Specialist for Global Trials

ThermoFisher Scientific; Paris; Sur place; EUR 52 000 - 74 000; Plein temps

Résumé du poste

Thermo Fisher Scientific in France seeks a Country Approval Specialist to manage and coordinate country submissions aligned with global strategy. You will liaise with internal teams to ensure regulatory compliance and timely site activation across the country.

The role requires strong knowledge of local regulatory guidelines, fluency in French, and experience with MoH/EC submissions. Office-based, standard Mon-Fri schedule, with cross-functional collaboration.

Qualifications

• Bachelor's degree or equivalent and relevant formal academic qualification.
• 2+ years of related experience.

Responsabilités

• Prepares and coordinates local regulatory submissions in line with global strategy.
• Provides local regulatory strategy advice to internal clients.
• Coordinates country-specific SIA services and project coordination.
• May have contact with investigators for submission related activities.
• Key-contact at country level for submission-related activities.
• Ensures site start-up activities align with submission timelines and critical path.

Connaissances

Communication

Interpersonal skills

Attention to detail

Negotiation

Computer skills

French & English fluency

Medical terminology

Teamwork

Organizational skills

Regulatory knowledge

Formation

Bachelor's degree

Description du poste

Thermo Fisher Scientific in France seeks a Country Approval Specialist to manage and coordinate country submissions aligned with global strategy. You will liaise with internal teams to ensure regulatory compliance and timely site activation across the country.

The role requires strong knowledge of local regulatory guidelines, fluency in French, and experience with MoH/EC submissions. Office-based, standard Mon-Fri schedule, with cross-functional collaboration.