Job Overview

This role supports QARA International by ensuring regulatory compliance execution and budget governance across the region. The Regional RA Compliance and Budget Analyst partners closely with regional and local Regulatory Affairs teams to maintain compliant regulatory operations while enabling effective planning, tracking, and reporting of RA budgets.

Key Responsibilities

• Support regional Regulatory Affairs compliance activities to ensure adherence to applicable international and local regulatory requirements and internal procedures.
• Coordinate and maintain regulatory documentation, trackers, and records to support audits, inspections, and lifecycle management activities.
• Monitor, analyze, and report on regional RA budgets, including forecasting, accruals, and variance analysis in partnership with QARA leadership and finance.
• Support the development and execution of regional RA operational plans, ensuring alignment with compliance priorities and budget constraints.
• Track regulatory submissions, renewals, and commitments to support timely and compliant execution across countries in scope.
• Prepare compliance and budget reports, dashboards, and presentations for regional and global stakeholders.
• Partner with cross‑functional teams (Quality, Finance, Supply Chain, and Commercial) to support regulatory initiatives and cost‑effective execution.
• Contribute to continuous improvement initiatives by identifying opportunities to enhance regulatory processes, controls, and budget transparency.

Qualifications

Education

• Bachelor’s degree required, preferably in Life Sciences, Regulatory Affairs, Business, Finance, Biotechnology, Pharmacy, or a related discipline.
• Advanced degree (e.g., Master’s) preferred.

Required Experience and Skills

• At minimum 2 years of relevant experience in Regulatory Affairs, Quality, Compliance, Finance, or business operations within a regulated industry.
• Foundational knowledge of regulatory requirements and compliance principles, ideally within medical devices or healthcare.
• Experience supporting documentation management, reporting, and data tracking.
• Proficiency with Microsoft Excel and PowerPoint; experience with budget tracking tools or systems is an advantage.

Preferred Skills

• Experience supporting regional or international regulatory operations.
• Exposure to audits, inspections, or regulatory submissions support activities.
• Familiarity with QMS, regulatory information management systems, or enterprise financial systems.
• Ability to work effectively in a matrixed, global environment.
• Interest in developing a career within Regulatory Affairs, Quality, or Compliance.
• Strong analytical skills with the ability to interpret financial and operational data.
• Effective written and verbal communication skills for cross‑functional collaboration.
• Strong organizational skills and attention to detail, with the ability to manage multiple priorities.

Languages

• Intermediate in English; additional Spanish is a plus.

Travel

Limited regional or international travel may be required.

Certifications

Regulatory or finance‑related certifications are a plus but not required.