Portugal Regulatory Submissions Specialist

ThermoFisher Scientific; Lisboa; Presencial; EUR 42 000 - 62 000; Tempo integral

Resumo da oferta

Thermo Fisher Scientific is seeking a Country Approval Specialist to manage and coordinate regulatory submissions at the country level, aligning with global submission strategies. You will work with MoH, EC, and other national applications to ensure timely approvals and robust regulatory documentation.

The role requires 2+ years in regulatory submissions, strong communication, and excellent attention to detail within a team environment.

Qualificações

• Bachelor's degree or equivalent and relevant formal academic qualification.
• 2+ years of experience in a related regulatory or submission role.
• Experience coordinating local regulatory submissions in line with global strategy.

Responsabilidades

• Prepares, reviews and coordinates local regulatory submissions (MoH, EC, etc.) according to global strategy.
• Provides local regulatory strategy advice to internal clients.
• Coordinates project-specific local SIA services and activities.
• May contact investigators for submission-related activities.
• Acts as key country contact for ethical or regulatory submission activities.
• Coordinates with internal departments to align sites and study activation with submission timelines.
• Supports feasibility activities and maintains trial status in tracking databases.
• Maintains knowledge of PPD/Client SOPs and current regulatory guidelines.

Conhecimentos

Oral communication

Written communication

Interpersonal skills

Attention to detail

Negotiation skills

Computer skills

English proficiency

Medical terminology

Teamwork

Organizational skills

Regulatory knowledge

Formação académica

Bachelor's degree

Descrição da oferta de emprego

Thermo Fisher Scientific is seeking a Country Approval Specialist to manage and coordinate regulatory submissions at the country level, aligning with global submission strategies. You will work with MoH, EC, and other national applications to ensure timely approvals and robust regulatory documentation.

The role requires 2+ years in regulatory submissions, strong communication, and excellent attention to detail within a team environment.