Regulatory Affairs Liaison — Global Submissions Lead

ThermoFisher Scientific; Italia; À distance; EUR 60 000 - 90 000; Plein temps

Résumé du poste

Thermo Fisher Scientific seeks a Sr Regulatory Affairs Specialist to provide regulatory advice and manage global submissions. You will interface with internal stakeholders and health authorities to ensure compliant strategies.

The role emphasizes collaboration with project teams, preparation of regulatory documents, and QC of submissions, leveraging experience in EU and other regions and strong English communication.

Qualifications

• Bachelor's Degree in a life science field is preferred.
• Regulatory experience and ability to work globally.
• Experience with regulatory submissions in EU and other regions.
• Strong English communication, written and verbal.

Responsabilités

• Provide regulatory advice and carry out global submissions.
• Act as liaison with internal stakeholders and project teams.
• Prepare and assemble regulatory submission packages and perform QC review.
• Interacts with Health Authorities regarding regulatory strategy and submissions.
• Coordinate with Project Managers to align regulatory activities.

Connaissances

Regulatory affairs

English proficiency

Team collaboration

Attention to detail

Project coordination

Clinical trials knowledge

Time management

Formation

Bachelor's Degree

Outils

MS Office

eTMF

CTMS

Description du poste

Thermo Fisher Scientific seeks a Sr Regulatory Affairs Specialist to provide regulatory advice and manage global submissions. You will interface with internal stakeholders and health authorities to ensure compliant strategies.

The role emphasizes collaboration with project teams, preparation of regulatory documents, and QC of submissions, leveraging experience in EU and other regions and strong English communication.