Start-up Regulatory Expert

Há 5 dias

São Paulo, São Paulo, Brasil beBeeRegulatory Tempo inteiro US$45.000 - US$60.000
Regulatory and Start-up Professional

We are seeking a highly skilled Regulatory and Start-up Specialist to join our team. As a key member of our organization, you will be responsible for executing feasibility, site identification regulatory, start-up, and maintenance activities in accordance with regulations, SOPs, and project requirements at the regional or country level.

Key Responsibilities:
  • Serve as a Single Point of Contact (SPOC) to perform feasibility, site activation, and some maintenance activities in assigned studies for investigative sites, according to applicable regulations, SOPs, and work instructions.
  • Prepare site documents, reviewing for completeness and accuracy.
  • Inform team members of completion of regulatory contractual, and other documents for individual sites.
  • Update and maintain internal systems, databases, tracking tools, timelines, and project plans with accurate and complete project-specific information.
  • Review, track, and follow up the progress, approval, and execution of required documents such as questionnaires, CDAs, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents.

This role requires advanced knowledge within a specific discipline typically gained through extensive work experience and/or education.

Requirements:
  • Bachelor's Degree in Life sciences or a related field.
  • 1-2 years of experience in clinical research regulatory and the following particular experience: CEP/CONEP - initial submission for Main Site and remaining sites, amendments to Main Site and Remaining sites, Notifications; ICF - Review and adaptation of local requirements (Country customization); ANVISA (MoH) - Initial DEEC Submission, Substantial Protocol Amendments, FAEC Update (Anvisa Clinical trial Form), annual study report (DEEC), Annual Safety Report (DDCM).
  • Advanced level of English skills.
  • Great communication skills and ability to work in a team.

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