Global Regulatory Submissions Director

hace 4 semanas

Ciudad de México, Ciudad de México SAO Fortrea Brazil Limitada A tiempo completo

As a leading global contract research organization with a focus on scientific rigor and extensive clinical development experience, SAO Fortrea Brazil Limitada provides pharmaceutical, biotechnology, and medical device customers with a wide range of clinical development, patient access, and technology solutions across multiple therapeutic areas.

The Global Regulatory Submissions Manager will collaborate with peers across the organization to achieve client-centric delivery in a matrix environment, particularly collaborating with all stakeholders within Site Readiness.

Please note that this is not a people manager position, and relocation support or sponsorship will not be provided.

Key Responsibilities:

  • Oversight and accountability for RA/IRB/EC/Third Body submissions, including submission strategy, timeline planning, and delivering to agreed-upon timelines by tracking submission/approval timelines against projected milestones in relevant systems.
  • Provides consolidated country requirements and regular status updates to project teams and clients, as applicable.
  • Responsible for ensuring compliance of deliverables to applicable regulations, guidance requirements, and client requests by preparing, reviewing, and providing input to core study documents, as applicable. This may include compiling, reviewing, and distributing core packages, quality controlling core packages, and country packages, maintenance, and close-out.
  • Provides high-quality advice on regulatory issues to project team members and clients by maintaining awareness of current regulatory legislation, guidance, and practice related to RA, IRB/EC, and Third Body submissions.
  • Where applicable and with suitable experience, provides guidance and regulatory expertise on the application of the EU CTR in CTIS to other stakeholders. Manages applicable user access to CTIS and acts as a backup in case of unexpected absences of other team members.
  • Reviews and inputs required Start-Up project plans. Distributes, implements, and monitors compliance to Start-Up project plans with respect to RA/IRB/EC/Third Body submissions.
  • E nsures responsible deliverables are met within required timelines, maintaining awareness of Green Light (GL) approval and Site Ready to Enroll (RTE) milestones. Proactively identifies and escalates to Start-Up Leads any risks to meeting deliverables. Manages projects according to the billing guide to ensure work is performed within budget. Notifies the Start-Up Lead of hours identified as Out-of-Scope.
  • Proactively engages in both quality assurance and risk management activities to ensure project deliverables are met. Initiates improvements to enhance the efficiency and quality of the submission work performed on assigned projects. Supports audits (internal and external) and inspections, as needed. Supports resolution of any findings.
  • Presents/attends at external and internal meetings, including project core teams and client meetings, Pre-Post Award Transition (PPAT) and Time Expectations Meetings (TEM), Kick-Off Meetings (KOM).
  • Contributes to the development of the group through participating and leading in process improvement initiatives, e.g., developing and updating SOPs.

Requirements:

  • 7-10 years of experience in the Pharmaceutical industry or Drug Development in Regulatory Affairs.
  • Excellent communication, organization, and planning skills with an attention to detail.
  • Extensive experience in leading clinical trial applications at a regional/global level.
  • Direct project management skills and ability to work independently.
  • Understanding of and ability to determine relevance of governmental regulatory processes and regulations as they pertain to investigational drug regulations, in particular.
  • Bachelor's degree or higher.
  • Fluency in English.

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