Regulatory Affairs Strategist & Liaison

ThermoFisher Scientific; United States; A distancia; USD 100.000 - 150.000; Jornada completa

Descripción de la vacante

Thermo Fisher Scientific in the United States is seeking a Sr Regulatory Affairs Specialist - Regulatory liaison to support global regulatory submissions and strategy. You will collaborate with internal stakeholders and health authorities to ensure compliant submissions and timely approvals.

Responsibilities include preparing global regulatory documents, QC review of submissions, coordinating with project teams, and advising on regulatory strategy.

Formación

• Bachelor's degree in Pharmacy or Life Science required or advantageous.
• Regulatory experience or combination of education and experience considered.
• Strong English communication skills, written and verbal.

Responsabilidades

• Provides regulatory advice and carries out projects in regulatory affairs services.
• Acts as liaison with internal stakeholders in regulatory affairs.
• Performs day-to-day operational aspects: assessment of regulatory documents, preparation and assembly of global regulatory submissions, QC review of final submission package.
• Interfaces with project teams and Health Authorities regarding regulatory strategy/submission activities.
• Develops and maintains cooperative working relationships with Project Managers and project team members for assigned projects.
• Advises and directs project team as to their responsibilities relative to regulatory strategy/submission activities.
• Acts as a key liaison between Regulatory Affairs Department and project team for assigned projects.

Conocimientos

Regulatory affairs experience

English communication

Cross-functional collaboration

Attention to detail

Project coordination

Educación

Bachelor's degree in Pharmacy or Life Science

Herramientas

eTMF

CTMS

Microsoft Office

Descripción del empleo

Thermo Fisher Scientific in the United States is seeking a Sr Regulatory Affairs Specialist - Regulatory liaison to support global regulatory submissions and strategy. You will collaborate with internal stakeholders and health authorities to ensure compliant submissions and timely approvals.

Responsibilities include preparing global regulatory documents, QC review of submissions, coordinating with project teams, and advising on regulatory strategy.