Regulatory Affairs Specialist

2 semanas atrás

São Paulo, São Paulo, Brasil Thermo Fisher Scientific Tempo inteiro
Job Summary

We are seeking a highly skilled Country Approval Specialist to join our team at Thermo Fisher Scientific. As a key member of our regulatory affairs team, you will play a critical role in ensuring the successful submission and approval of our products in various countries.

Key Responsibilities
  • Regulatory Submission Coordination: Prepare, review, and coordinate local regulatory submissions, including MoH, EC, and other national applications, in alignment with our global submission strategy.
  • Local Regulatory Strategy Advice: Provide guidance on local regulatory strategy to internal clients, ensuring compliance with relevant regulations and guidelines.
  • Project Coordination: Coordinate project-specific local SIA services and ensure alignment with submission activities and timelines.
  • Communication and Collaboration: Maintain effective communication with investigators, internal functional departments, and other stakeholders to ensure seamless coordination of submission-related activities.
  • Regulatory Compliance: Ensure compliance with PPD's target cycle times for site activation and maintain accurate and timely trial status information on PPD tracking databases.
  • Country-Specific Support: Develop country-specific Patient Information Sheet/Informed Consent form documents and support the coordination of feasibility activities as required.
  • Regulatory Knowledge: Maintain knowledge of and understand PPD SOPs, client SOPs/directives, and current regulatory guidelines applicable to services provided.
Requirements

To be successful in this role, you will need to have a strong understanding of regulatory affairs and a proven track record of coordinating successful submissions. You will also need to be able to work effectively in a team environment and communicate complex information to internal stakeholders.

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