Data Solutions Coordinator – Reg Intel

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

📋 Description

• Oversee global regulatory bodies across more than 150 countries for updates impacting the Pharmaceutical, Biologics, MedTech, and Animal Health sectors.

• Assess regulatory developments for their relevance to industry scope and potential operational or strategic implications.

• Differentiate between actionable regulatory modifications and high-volume informational updates.

• Organize and categorize regulatory intelligence within the platform.

• Implement industry and Good Practice (GxP) tagging.

• Extract metadata such as effective dates, consultation deadlines, and enforcement timelines.

• Connect related regulatory documents.

• Monitor the evolution of global regulatory frameworks and pinpoint emerging trends.

• Collaborate with internal teams to enhance monitoring scope and classification logic.

• Maintain data accuracy and integrity through quality assessments and KPI monitoring.

• Continuously enhance regulatory intelligence workflows and structured data processes.

• Convey regulatory intelligence insights, updates, and trends clearly and accurately across various platforms.

⛳️ Requirements

• A minimum of 4 years' experience in Regulatory Affairs, Quality Assurance, GxP, or Regulatory Intelligence in the Pharmaceutical, Biologics, Medical Device, or Animal Health sectors is preferred.

• Strong grasp of GxP principles and global regulatory frameworks.

• Capability to interpret regulatory language and evaluate its practical implications for the industry.

• Experience in analyzing regulatory updates or compliance-related documents.

• A Master’s degree (M.S.) in Regulatory Affairs, Pharmaceutics, or Quality Assurance is preferred.

• Basic knowledge of current technologies utilized in data operations.

• Proficiency in using data-operation technologies and a willingness to adopt new ones.

🏝️ Benefits

• Employees have the option to work remotely.

• We are an equal opportunity employer.

• A diverse and inclusive workplace environment.

• Confidential treatment of applicant information in accordance with EEO guidelines.