Regional Associate, Quality and Regulatory Affairs-Asia Pacific

Overview

Regional Associate supporting quality and regulatory affairs for pharmaceutical products and medical devices across Asia Pacific markets.

What you'll do

• Manage product and device lifecycle activities, including variations, labelling, safety updates, and annual reports.
• Prepare and implement regulatory strategies for projects across Asia Pacific countries.
• Review and maintain product labels and artwork for content accuracy.
• Support country regulatory teams with troubleshooting and project solutions.
• Maintain regulatory records, registration statuses, and product information.
• Coordinate post-market approval requirements, reports, notifications, and incident reporting.
• Develop and implement regulatory-affairs SOPs and update regulatory databases.

What you'll need

• Expertise in regulatory registrations and submissions.
• Expertise with artwork management systems.
• Knowledge of national and regional regulatory requirements.
• Ability to coordinate with country, regional, and global regulatory teams.
• Ability to review regulatory strategies against business requirements.

Details

• Location: Gurugram, Haryana, India.
• Regional scope: Asia Pacific markets.