International Regulatory Submissions Specialist

2 semanas atrás


São Paulo, São Paulo, Brasil SAO Fortrea Brazil Limitada Tempo inteiro

As a leading global contract research organization (CRO) committed to scientific excellence and extensive expertise in clinical development, SAO Fortrea Brazil Limitada provides pharmaceutical, biotechnology, and medical device clients with a comprehensive array of solutions in clinical development, patient access, and technology across more than 20 therapeutic areas. With a workforce exceeding 19,000 professionals operating in over 90 countries, Fortrea is transforming drug and device development on a global scale.

International Regulatory Submissions Specialist will work collaboratively with colleagues throughout the organization to ensure client-focused delivery in a matrix environment, emphasizing cooperation within Site Readiness.

Please note that this position does not entail managing personnel, and relocation assistance or sponsorship is not available.

Key Responsibilities:

  • Oversee and ensure accountability for RA/IRB/EC/Third Body submissions, including submission strategy, timeline management, and timely delivery by monitoring submission/approval timelines against planned milestones in relevant systems.
  • Provide consolidated country requirements and regular updates to project teams and clients as necessary.
  • Ensure that deliverables adhere to applicable regulations, guidance, and client specifications by preparing, reviewing, and contributing to core study documents, including the compilation, review, and distribution of core and country packages.
  • Offer expert regulatory guidance to project team members and clients by remaining informed about current regulatory laws, guidance, and practices related to RA, IRB/EC, and Third Body submissions.
  • Guide and advise on EU CTR applications in CTIS to stakeholders. Manage user access to CTIS and serve as a backup when required.
  • Review and contribute to Start-Up project plans. Monitor compliance with the project plan concerning submissions.
  • Ensure that deliverables are met within timelines by tracking Green Light approval and Site Ready to Enroll milestones. Proactively identify and escalate any risks to meeting deliverables.
  • Engage in quality assurance and risk management activities to ensure project objectives are achieved. Propose enhancements for improved efficiency and quality. Support audits and inspections as necessary.
  • Participate in external and internal meetings such as project core team meetings, client meetings, and various start-up meetings.
  • Contribute to the team's development by participating in process improvement initiatives and SOP updates.

Requirements:

  • Several years of experience in the pharmaceutical industry or drug development in regulatory affairs.
  • Strong communication, organizational, and planning skills with a keen attention to detail.
  • Extensive experience in managing clinical trial applications at regional and global levels.
  • Direct project management capabilities with the ability to work independently.
  • Understanding of governmental regulatory processes and regulations related to investigational drug regulations.
  • Bachelor's degree or higher.
  • Proficiency in English.

SAO Fortrea Brazil Limitada seeks proactive problem solvers and innovative thinkers who share our commitment to overcoming challenges in clinical trials. Our mission is to revolutionize the development process, ensuring the swift delivery of groundbreaking ideas and treatments to patients. Join our exceptional team and experience a collaborative environment that fosters personal growth and enables you to make a significant global impact.



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