Global Regulatory Submissions Manager

hace 1 mes


San José, San José, Costa Rica SAO Fortrea Brazil Limitada A tiempo completo
Job Summary

SAO Fortrea Brazil Limitada is seeking a highly skilled Global Regulatory Submissions Manager to join our team. As a key member of our regulatory affairs team, you will be responsible for overseeing and ensuring the compliance of regulatory submissions, including submission strategy, timeline planning, and delivering to agreed-upon timelines.

Key Responsibilities
  • Develop and implement submission strategies to ensure timely and compliant regulatory submissions.
  • Collaborate with cross-functional teams to ensure regulatory compliance and adherence to client requests.
  • Provide high-quality advice on regulatory issues to project teams and clients, maintaining awareness of current regulatory legislation and guidance.
  • Manage user access to CTIS and provide regulatory expertise on the application of the EU CTR in CTIS.
  • Review and input into required start-up project plans, ensuring compliance to regulatory requirements.
  • Proactively identify and escalate risks to meeting deliverables, managing projects according to the billing guide.
  • Engage in quality assurance and risk management activities to ensure project deliverables are met.
Requirements
  • 7-10 years' 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.
  • Bachelor's degree or higher.
  • Fluency in English.


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