Country Regulatory Submissions Specialist

ThermoFisher Scientific; Roma; Ibrido; EUR 50.000 - 70.000; Tempo pieno

Descrizione del lavoro

Thermo Fisher Scientific in Rome, Italy seeks a Country Approval Specialist to manage and coordinate local regulatory submissions in line with global strategy. You will provide regulatory strategy guidance to internal clients and support start-up activities at the country level.

Key responsibilities include coordinating MoH/EC submissions, maintaining SOP-aligned country files, and ensuring site activation timelines align with submission plans.

Competenze

• Bachelor's degree or equivalent with relevant formal academic qualification.
• Experience or knowledge enabling local regulatory submissions and coordination.
• Familiarity with MoH/EC regulatory processes and documentation.

Mansioni

• Prepare, review and coordinate local regulatory submissions (MoH, EC, etc.) in line with EU/global strategy.
• Provide local regulatory strategy advice to internal clients.
• Coordinate start-up services and project activities related to submissions.
• Serve as country-level contact for submission-related activities.
• Coordinate with internal departments to align site start-up activities with submission timelines.

Conoscenze

Effective communication

Interpersonal skills

Attention to detail

Negotiation

Computer skills

English proficiency

Medical terminology

Team collaboration

Formazione

Bachelor's degree or equivalent

Strumenti

MS Office

Descrizione del lavoro

Thermo Fisher Scientific in Rome, Italy seeks a Country Approval Specialist to manage and coordinate local regulatory submissions in line with global strategy. You will provide regulatory strategy guidance to internal clients and support start-up activities at the country level.

Key responsibilities include coordinating MoH/EC submissions, maintaining SOP-aligned country files, and ensuring site activation timelines align with submission plans.