Senior Regulatory Professional

Há 3 dias

Recife, Pernambuco, Brasil beBeeRegulatory Tempo inteiro R$45.000 - R$63.000

Job Overview:

As a key member of our global team, you will be responsible for managing site start-up activities and ensuring the collection of essential documents. Your primary contact with investigative sites will involve coordinating the preparation and submission of study documentation to regulatory authorities.

Responsibilities:

  • Maintain awareness of current regulatory standards and legislation in assigned countries.
  • Coordinate data collection and organize required information for submissions to EC/IRB/Third body/Regulatory Authorities.
  • Compile and prepare routine submission files, liaising with regulatory bodies as necessary.
  • Liaise with internal and external vendors for regulatory authority submissions.
  • Perform final review of submission documents.
  • Ensure timely completion of start-up and maintenance activities, adhering to client expectations and applicable laws.
  • Escalate study issues promptly and perform other duties as assigned.

In Country Specific Tasks (Global):

  • Serve as primary contact for investigative sites and ensure timely document collection.
  • Collect and track necessary documents, performing quality reviews, formatting, and compilation of final documents.
  • Ensure high-quality documents are filed and systems are updated on an ongoing basis.
  • Participate in team meetings as necessary.
  • Assist in strategy definition for Site Activation and provide projections and timelines to study teams.
  • Review and customize country-specific patient informed consent forms for compliance with local requirements and protocol.
  • May support negotiation of site contracts and budgets, tracking progress and intervening as necessary.
  • Identify and escalate risks to meeting deliverables to Submission Leads.

Clinical Trials Information System (CTIS) Tasks (EU Centralized Role):

  • Assist in uploading submission documentation to CTIS, interacting with and monitoring notifications and alerts.
  • Evaluate all milestones and events for the trial within mandated timelines.

Qualifications:

  • University degree (life science preferred) or certification in a related allied health profession from an accredited institution AND 2 years' experience in clinical research, including ICH guidelines and RA, IRB/IEC regulations.
  • Familiarity with investigator start-up documents and contract/budget negotiation processes.
  • Demonstrated understanding of research protocol requirements and ability to communicate them effectively.

Experience:

  • Minimum 3 years' experience in clinical development or start-up/regulatory process.
  • Working knowledge of ICH, RA, IRB/IEC, and other applicable regulations/guidelines.

Physical Demands/Work Environment:

  • General office environment.

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