Senior Regulatory Affairs Specialist
HybridSão Paulo, São Paulo, Brazil
Job Summary
Conduct country and regional clinical trial regulatory deliverables for DDCM and DEEC submissions, ensuring alignment with ICH-GCP, study specifics, and applicable regulations. Directly interact with regulatory authorities, primarily ANVISA, and manage the preparation, coordination, and review of submission documentation. Track central submission and approval progress within CTMS and eTMF systems while overseeing translation management and project-specific training. Collaborate with in-country and regional teams to meet deliverables, mitigate submission risks, and contribute to system and procedure reviews. Adhere to study budgets and support the maintenance of accurate clinical trial intelligence.
Required Qualifications
- 4+ years of experience in clinical trial submissions
- Experience ensuring regulatory deliverables are performed in accordance with all relevant regulations, guidelines, policies and procedures within contractual timelines and budget with sound scientific/technical principles
- Advanced knowledge of country/region Regulatory Agency (RA) and other country-level authority clinical trial requirements, as applicable
- Read, write and speak fluent English
- Employment with ICON is contingent upon having the legal right to work in the country where the role is based
Desired Qualifications
- Become involved, when required, staff training/mentoring
- Contribute to the review of ICON systems and procedures as appropriate
- Recognize, exemplify and adhere to ICON's values which center around our commitment to People, Clients and Performance
- Embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs
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