Country Regulatory Specialist, Clinical Research

Accountabilities:

Manage country-level regulatory and ethics submission activities from study start-up through project completion, ensuring compliance with Brazilian regulations, project requirements, timelines, budgets, and quality standards.
Prepare and submit applications to regulatory authorities, central and local ethics committees, and other relevant institutions, including initial submissions, amendments, periodic notifications, safety reports, and other required documentation.
Act as the primary country-level regulatory contact for health authorities and ethics committees, coordinating responses to queries, resolving submission-related issues, and escalating risks when necessary.
Provide regulatory expertise during business development, study feasibility, and site selection activities, advising project teams on local requirements, approval timelines, and potential operational challenges.
Forecast submission and approval timelines, track milestones, analyze delays, develop mitigation strategies, and communicate risks to project leads and relevant stakeholders.
Monitor changes in local regulatory requirements and guidelines, maintain accurate regulatory intelligence records, contribute to regulatory impact assessments, and implement appropriate operational updates.
Ensure regulatory documentation is accurately maintained in the Trial Master File (TMF) in accordance with applicable standard operating procedures, work instructions, and customer requirements.
Support the development of local regulatory training materials, contribute to continuous quality improvement, and provide expertise when coordinating ethics committee or institutional review board vendors, as required.
Monitor project workload, scope, budgeted effort, and working hours, maintaining accurate records and promptly escalating discrepancies or resource concerns.
Requirements:
A bachelor's degree in a relevant field is preferred, or an equivalent combination of education and professional experience.
At least 3–4 years of experience in clinical research, preferably in regulatory affairs or clinical trial regulatory submissions.
Solid understanding of clinical trial processes across Phases I–IV, including ICH Good Clinical Practice (GCP) guidelines and the regulatory requirements governing clinical research in Brazil.
Experience with country-specific clinical trial submission procedures and applicable quality standards, such as GCP, Good Pharmacovigilance Practices (GVP), and ISO 14155, as relevant.
Strong knowledge of regulatory authority and ethics committee processes, submission requirements, approval timelines, and ongoing study maintenance obligations.
Excellent organizational, analytical, and problem-solving skills, with the ability to manage competing priorities, meet deadlines, and deliver accurate, high-quality work.
Strong written and verbal communication, documentation, presentation, and stakeholder management skills, with the ability to engage effectively with regulatory authorities, ethics committees, and cross-functional teams.
Advanced English proficiency to support communication and collaboration within an international clinical research environment.
Proficiency in Microsoft Office and familiarity with web-based systems, electronic documentation platforms, email, and internet-based research tools.
Ability to work independently and collaboratively in a fast-paced, evolving environment while maintaining attention to detail, regulatory compliance, and accountability.
Benefits:
Remote flexibility: Work remotely from Brazil in a full-time position.
Career development: Access opportunities for professional growth, career progression, and ongoing learning.
Training and development: Benefit from technical training, therapeutic-area education, and opportunities to strengthen regulatory and clinical research expertise.
Supportive management: Collaborate with engaged leaders and experienced professionals in a knowledge-sharing environment.
Recognition and rewards: Access peer recognition initiatives and a total rewards program.
Global collaboration: Work with international, cross-functional teams and gain exposure to diverse clinical research projects and therapeutic areas.
Meaningful impact: Contribute to clinical research that supports the development of innovative therapies and improves patient outcomes worldwide.
Inclusive culture: Join a collaborative environment that values diverse perspectives, professional contributions, and continuous improvement.