Senior Country Regulatory Specialist

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

📋 Description

• Oversee country regulatory operations from the initiation of studies to the conclusion of projects.

• Offer expertise in country-specific ethics and regulatory submissions within established timelines, budget constraints, and quality benchmarks.

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

• Maintain up-to-date regulatory country intelligence in regulatory intelligence databases.

• Engage with clients regarding requirements set by Regulatory Authorities and local regulations.

• Advise on regulatory submission strategies prior to award.

• Provide country-specific regulatory insights for business development presentations and site selection processes.

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

• Prepare and submit documents to Central Ethics Committees, Local Ethics Committees, Regulatory Authorities, hospitals, including amendments, notifications, and safety submissions.

• Collaborate with Regulatory Authorities and Ethics Committees to coordinate responses to inquiries.

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

• Ensure that relevant documents are filed appropriately in the Trial Master File.

• Complete or assist in Regulatory Impact Assessments and implement operational changes in response to regulatory updates.

• Create or assist in the development of local regulatory training materials.

• Mentor and train junior Country Regulatory Specialists.

• Assist Procurement in managing Ethics/IRB vendors when needed.

• Contribute to the development of SOPs and Work Instructions while promoting continuous quality enhancement.

• Review SOPs and Work Instructions, ensure training compliance, and accurately report timesheets.

• Monitor workloads, project scopes, budgeted efforts, and project hours; escalate any discrepancies as necessary.

⛳️ Requirements

• A minimum of a BA or BS degree is preferred.

• At least 5-6 years of experience in a Clinical Research setting, or a comparable combination of education and experience.

• Comprehensive understanding of the clinical trial process across Phases I-IV and ICH GCP guidelines.

• In-depth knowledge of clinical trial submission processes according to country-specific and local regulations.

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

• Exceptional organizational and problem-solving abilities.

• Strong skills in presentation, documentation, influencing, and communication.

• A team-oriented mindset.

• Knowledge and interpersonal skills necessary for training and mentoring junior Country Regulatory Specialists.

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

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

• Ability to work autonomously as well as collaboratively within a team.

🏝️ Benefits

• Opportunities for career development and progression.

• Supportive and engaged management team.

• Training in technical and therapeutic areas.

• Peer recognition initiatives.

• Comprehensive total rewards program.

• An inclusive workplace culture.

• Reasonable accommodations provided when appropriate.