Global Country Submissions Specialist — Regulatory Coordination

ThermoFisher Scientific; Comisión de Fomento de Perú; Híbrido; ARS 850.000 - 1.200.000; Jornada completa

Descripción de la vacante

Thermo Fisher Scientific in Argentina seeks a Country Approval Specialist to manage local regulatory submissions in alignment with global strategy. You will coordinate MoH/EC submissions, provide local regulatory advice, and liaise with internal teams to ensure timely site activations and study filings.

The role requires a Bachelor's degree and 2+ years of relevant experience, strong communication and regulatory knowledge, and the ability to work both independently and in a team within an office

Formación

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• 2+ years experience in related role or similar environment
• Equivalency may be considered with combination of education and experience

Responsabilidades

• Prepares, reviews and coordinates local regulatory submissions (MoH, EC) in alignment with global strategy.
• Provides local regulatory strategy advice to internal clients.
• Coordinates project-specific local SIA services and manages submission-related activities.
• May liaise with investigators for submission-related tasks.
• Primary country-level contact for regulatory submission activities.
• Ensures site activation timelines align with submission processes and critical path.

Conocimientos

Oral and written comms

Interpersonal skills

Attention to detail

Negotiation skills

Computer skills

English proficiency

Medical terminology

Teamwork/independence

Organizational skills

Regulatory knowledge

Educación

Bachelor's degree or equivalent

Descripción del empleo

Thermo Fisher Scientific in Argentina seeks a Country Approval Specialist to manage local regulatory submissions in alignment with global strategy. You will coordinate MoH/EC submissions, provide local regulatory advice, and liaise with internal teams to ensure timely site activations and study filings.

The role requires a Bachelor's degree and 2+ years of relevant experience, strong communication and regulatory knowledge, and the ability to work both independently and in a team within an office