FSP Country Approval Specialist
Thermo Fisher Scientific
Thermo Fisher Scientific seeks a Country Approval Specialist to manage and coordinate local regulatory submissions for clinical trials across multiple countries. This remote role involves preparing submissions aligned with global strategy, providing regulatory guidance, and ensuring compliance with applicable guidelines and timelines.
Responsibilities
- Prepare, review, and coordinate local regulatory submissions aligned with global strategy
- Provide local regulatory strategy guidance to internal stakeholders
- Serve as key contact for regulatory and ethical submission activities at country level
- Coordinate with internal departments to align site start-up activities with submission timelines
- Maintain trial status information and regulatory databases accurately and timely
Requirements
- Bachelor's degree or equivalent formal academic/vocational qualification
- 2+ years relevant experience in regulatory affairs or clinical trial management
- Strong written and oral communication skills in English
- Knowledge of regional and national regulatory guidelines
- Proficiency with computer systems and software applications
- Attention to detail and quality documentation practices
- Negotiation and interpersonal skills
Vacante publicada el 1 día atrás
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