Country Regulatory Specialist, Clinical Research

This is a fully remote position, open to applicants in Brazil.

📋 Description

• Execute designated tasks associated with country regulatory operations under guidance.

• Offer delivery and expertise in country ethics and regulatory submissions from project initiation to completion.

• Act as the primary country-level liaison with Regulatory Authorities and Central/Regional Ethics Committees under project leadership supervision.

• Manage regulatory country intelligence within regulatory intelligence systems.

• Engage with clients regarding Regulatory Authority and local regulatory requirements.

• Advise on pre-award regulatory submission strategies.

• Provide country-level regulatory subject matter expertise for business development presentations and site selection processes.

• Keep informed on country-specific startup timelines and offer strategic recommendations.

• Anticipate submission and approval timelines, monitor milestones, analyze delays, propose mitigation strategies, and escalate risks as necessary.

• Prepare and submit documents to Central EC, Local EC, Regulatory Authority, hospitals, amendments, periodic notifications, safety notifications, and other local submissions.

• Collaborate with Regulatory Authorities and Ethics Committees, coordinate responses to queries, and identify solutions to challenges.

• Serve as the country-level regulatory subject matter expert throughout assigned projects.

• Submit relevant documents to the Trial Master File in accordance with SOPs and client requirements.

• Complete or assist with Regulatory Impact Assessments and implement operational actions as regulations evolve.

• Create or assist in developing local country regulation training materials.

• Support Procurement in managing Ethics/IRB vendors when necessary.

• Ensure ongoing quality improvement for country-level submissions and communications.

• Adhere to SOPs and Work Instructions, maintain training compliance, and ensure accurate timesheet records.

• Monitor workload, scope, budgeted efforts, and project hours; escalate discrepancies when identified.

⛳️ Requirements

• A minimum of a BA or BS is preferred.

• At least 3-4 years of experience in a Clinical Research environment, or a comparable combination of education and experience.

• Ideally, possess experience in a regulatory setting.

• In-depth understanding of clinical trial processes across Phases I-IV and ICH GCP.

• Comprehensive knowledge of country-specific and local clinical trial submission processes and regulations.

• Experience adhering to applicable GxPs (e.g., GVP, GCP, ISO 14155).

• Excellent organizational and problem-solving abilities.

• Proven track record of meeting deadlines with a high quality of work.

• Strong skills in presentation, documentation, influencing, and both written and verbal communication.

• A team-oriented mindset.

• Proficient in Microsoft Office Suite, web-based systems, voicemail, email, and Internet applications.

• Capability to manage competing priorities in a dynamic, fast-paced environment.

• Demonstrated ability to work independently as well as collaboratively within a team.

• Advanced proficiency in English.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Technical and therapeutic area training provided.

• Peer recognition initiatives.

• Comprehensive total rewards program.

• Inclusive workplace culture.

• Remote work arrangement available (100% remote in Brazil).