Country Regulatory Specialist, Clinical Research
New
J
JobgetherClinical research
Work remotely from BrazilFull-TimeMiddle
Salary not disclosed
Apply NowOpens the employer's application page
Job Details
- Languages
- Advanced English proficiency
- Experience
- At least 3–4 years of experience in clinical research, preferably in regulatory affairs or clinical trial regulatory submissions.
- Required Skills
- Microsoft Office
Requirements
- Have a bachelor's degree in a relevant field, preferred, or an equivalent combination of education and professional experience.
- Have at least 3–4 years of experience in clinical research, preferably in regulatory affairs or clinical trial regulatory submissions.
- Understand clinical trial processes across Phases I–IV, ICH Good Clinical Practice guidelines, and Brazilian clinical research regulations.
- Have experience with country-specific clinical trial submission procedures and applicable quality standards, including GCP, GVP, and ISO 14155 as relevant.
- Know regulatory authority and ethics committee processes, submission requirements, approval timelines, and ongoing study maintenance obligations.
- Demonstrate organizational, analytical, and problem-solving skills, including the ability to manage competing priorities and meet deadlines.
- Have written and verbal communication, documentation, presentation, and stakeholder management skills.
- Have advanced English proficiency for communication and collaboration in an international clinical research environment.
- Be proficient in Microsoft Office and familiar with web-based systems, electronic documentation platforms, email, and internet-based research tools.
- Be able to work independently and collaboratively while maintaining attention to detail, regulatory compliance, and accountability.
Responsibilities
- Manage country-level regulatory and ethics submissions from study start-up through project completion.
- Prepare and submit applications, amendments, periodic notifications, safety reports, and other required documentation.
- Coordinate responses to queries from health authorities and ethics committees, resolve submission issues, and escalate risks.
- Advise project teams on local requirements, approval timelines, and operational challenges during feasibility and site selection.
- Forecast submission and approval timelines, track milestones, analyze delays, and develop mitigation strategies.
- Monitor changes in local regulatory requirements and guidelines, maintain regulatory intelligence records, and implement operational updates.
- Maintain regulatory documentation in the Trial Master File in accordance with applicable procedures and customer requirements.
- Support local regulatory training, continuous quality improvement, and coordination of ethics committee or institutional review board vendors.
- Monitor project workload, scope, budgeted effort, and working hours, and escalate discrepancies or resource concerns.
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