Senior Regulatory Professional

2 semanas atrás

Brasil beBeeRegulatory Tempo inteiro US$86.365 - US$126.975

Job Overview:

You will be responsible for ensuring timely submissions to regulatory authorities, maintaining awareness of current regulatory standards, and serving as a local expert in project start-up activities.

Key Responsibilities:

  • Maintain awareness of regulatory legislation, guidance, and practice in assigned countries.
  • Coordinate and collect data required by regulatory authorities, including preparation of study documentation.
  • Compile and prepare routine submissions filed to regulatory authorities and liaise with them as applicable.
  • Liaise with internal and external vendors in the generation of regulatory authority submissions.
  • Perform review of final submission documents.
  • Ensure all assigned start-up and maintenance activities are on track, in accordance with client expectations and in compliance with applicable laws and guidelines, regulatory requirements, ICH/GCP, SOPs and quality standards.
  • Prevent and escalate study issues appropriately and in a timely fashion.

In Country Specific Tasks:

  • Serve as primary contact for investigative sites and ensure documents required are collected in a timely manner.
  • Collect and track necessary documents and perform quality review, formatting, and compilation of final documents for effective and compliant site activation and maintenance.
  • Ensure high-quality documents are filed and systems are updated on an ongoing and timely basis, making your team ready for an audit at any time.
  • Participate in team and project meetings as applicable.
  • Assist in strategy definition for Site Activation and provide accurate projections and timelines to study teams.
  • Review and customize country and site-specific patient informed consent forms for compliance with local requirements and protocol.
  • Proactively resolve informed consent issues and other potential difficulties with study sites.
  • May support negotiation of site contracts and budgets with sites, if applicable, and track progress of contract and budget milestones/developments.

Clinical Trials Information System (CTIS) Tasks:

  • Assist in upload of submission documentation to CTIS and interact with and monitor all notifications and alerts to ensure all milestones and events for the trial are met within the timelines mandated.

Required Skills and Qualifications:

  • Maintenance of regulatory awareness and expertise.
  • Strong communication and coordination skills.
  • Ability to work effectively with cross-functional teams.
  • Familiarity with regulatory requirements and procedures.
  • Excellent analytical and problem-solving skills.

Benefits:

The successful candidate will have the opportunity to work on a variety of projects, develop their knowledge and skills, and contribute to the success of the team.

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