Senior Regulatory Compliance Specialist

Há 20 horas

São Paulo, São Paulo, Brasil beBeeRegulatory Tempo inteiro R$80.000 - R$105.000

Country Approval Specialist Job Description

About the Role

We are seeking a highly skilled Country Approval Specialist to support our regulatory strategy and submission activities.

Key Responsibilities:
  • Provide local regulatory advice to internal clients under guidance from relevant authorities.
  • Coordinate project-specific services and ensure alignment with submission timelines.
  • Act as key-contact for ethical or regulatory submission-related activities at the country level.
  • Ensure site start-up activities align with submissions and agreed upon timelines.
  • Achieve target cycle times for site activation.
Additional Responsibilities:
  • Prepare compliance review packages for start-up CRA(s).
  • Develop country-specific patient information sheet/informed consent form documents.
  • Support feasibility activity coordination in accordance with agreed timelines.
  • Maintain trial status information on tracking databases.
  • Ensure local country study files and filing processes meet applicable requirements.
Required Skills and Qualifications

The ideal candidate will have knowledge of relevant SOPs, guidelines, and directives. Strong communication and organizational skills are essential for success in this role.

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