Senior Compliance Professional

Há 3 dias

Brasil beBeeRegulatory Tempo inteiro

Job Overview:

To excel as a Senior Regulatory Specialist, you must maintain awareness of current regulatory standards related to submissions and serve as a local expert in project start-up activities for Brazil. This role involves proactively interacting with authorities to provide guidance regarding requirements.

Key Responsibilities:

  • Maintain awareness of regulatory legislation, guidance, and practice in Brazil.
  • Coordinate the collection and organization of data and information required by authorities.
  • Compile and prepare routine submissions filed to authorities.
  • Liaise with internal and external vendors in the generation of submissions.
  • Perform a review of final submission documents.
  • Ensure that all assigned start-up and maintenance activities are on track in accordance with client expectations and comply with applicable laws and guidelines, ICH/GCP, SOPs, and quality standards.

In Country Specific Tasks:

  • Serve as primary contact for investigative sites and ensure necessary documents are collected in a timely manner.
  • Collect and track all necessary documents required and perform a quality review, formatting, and compilation of the final documents for effective site activation and maintenance without supervision.
  • Ensure high-quality documents are filed and systems are updated on an ongoing and timely basis, making us ready for an audit at any time.

Clinical Trials Information System (CTIS) Tasks:

  • Assist in uploading submission documentation to CTIS and monitor notifications and alerts to ensure milestones and events for the trial are met within timelines mandated.

Qualifications:

  • Hold a University/College degree or certification in a related allied health profession from an accredited institution AND have 2 years' work experience in clinical research, including a strong working knowledge of the ICH guidelines and RA, IRB/IEC regulations.

Experience:

  • Have a minimum of 3 years of experience in clinical development or start-up/regulatory process.
  • Have working knowledge of ICH, RA, IRB/IEC, and other applicable regulations/guidelines; familiarity with investigator start-up documents and contract negotiation process; previous interaction with operational project teams and investigative sites.

Working Conditions:

This is an excellent opportunity to develop your skills and expertise in a dynamic environment. You will be part of a collaborative team dedicated to delivering high-quality results.

About Us:

We are committed to fostering a culture of excellence, innovation, and teamwork. Our goal is to make a positive impact on the lives of patients and communities worldwide.

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