Regulatory Affairs Executive

Role & Responsibilities:
• Prepare, compile, and submit regulatory dossiers for pharmaceutical export registrations to global regulatory authorities
• Maintain CTD/eCTD documentation for product registrations, renewals, variations, and post-approval changes
• Ensure compliance with international regulatory requirements and current guidelines across export markets
• Act as a liaison with regulatory agencies, export authorities, and external consultants for submission queries and follow-ups
• Coordinate with internal teams including QA, QC, Production, R&D, and Supply Chain to collect required technical documentation
• Track submission timelines, monitor status, and respond to deficiency letters within defined timelines
• Maintain organized regulatory databases, files, and documentation as per regulatory and company standards
• Provide regulatory intelligence on evolving global regulations impacting pharmaceutical exports
• Support labeling, packaging, and artwork compliance as per importing country requirements

Qualification:
• Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Chemistry, or a related discipline

Experience:
• 1-4+ years of experience in pharmaceutical regulatory affairs
• Preferable exposure to export regulatory submissions and international markets

Skills:
• Strong knowledge of global regulatory frameworks and export documentation requirements
• Hands-on experience with CTD/eCTD dossier preparation and submission tracking
• Familiarity with electronic submission systems and regulatory agency portals
• Excellent communication, coordination, and stakeholder management skills
• Strong organizational ability and attention to detail
• Good command of written and spoken English

About the Company:
The organization operates within the pharmaceutical sector, supporting global product registrations and export compliance across multiple international markets. It emphasizes regulatory excellence, cross-functional collaboration, and adherence to global quality and compliance standards to ensure timely product approvals and sustainable business growth.