Regulatory Operations Specialist I

Overview

Manage laboratory instrument and equipment lifecycles, regulatory operations, and quality and validation activities in a cGMP environment.

What you'll do

• Manage installation, qualification, maintenance, and documentation for laboratory instruments.
• Prepare and review SOPs, protocols, validation master plans, and cGMP documents.
• Handle nonconformance reports, change controls, and corrective and preventive actions.
• Conduct data integrity assessments and evaluate instrument specifications against USP/EP standards.
• Manage import/export licenses, Dual Use NOCs, import certificates, applications, and reconciliations.
• Support audits, training, onboarding, mentoring, and equipment lifecycle activities.

What you'll need

• 4–7 years of experience in regulatory affairs, quality assurance, analytical science, packaging, pharmaceutics, material management, or related disciplines.
• Bachelor’s degree in pharmacy, science, engineering, B.Tech, packaging, polymer, or printing, or an equivalent qualification.
• Proficiency with Microsoft Office and document management or publishing tools.
• Understanding of pharmaceutical product lifecycles, regulatory requirements, GxP, and ICH-GCP guidelines.
• Strong organizational, analytical, review, and time-management skills.
• Ability to work independently, meet tight deadlines, and maintain quality.

Nice to have

• Knowledge of management information systems and electronic data management systems.
• Diploma or certification in Regulatory Affairs.
• Excellent root-cause analysis and process improvement skills.

Details

• Location: Mumbai.
• Work environment: Office or remote.