Cureton Biotech
Website:
cureton.in
Job details:
About Us:-
Cureton Biotech Pvt. Ltd. is dedicated to providing prime quality pharmaceutical products under its hood. We’re engaged in Pharmaceutical and Healthcare products as per the industrial standards GMP, WHO, and GLP to India and Globally.
Job Location:Okhla Industrial Area Phase – 1, New Delhi
Employment Type: Full Time | On-Site
*Salary: Up to ₹30,000 CTC Per Month
*Experience required: 3–5 Years (Pharma Industry / Export Documentation)
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Job Summary:
We are seeking an experienced and detail-oriented Regulatory Affairs Executive for a Merchant Exporter (Pharmaceuticals). The candidate will be responsible for managing regulatory compliance, export documentation, product registrations, and coordination with international regulatory authorities to ensure smooth export operations as per applicable guidelines.
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Key Responsibilities:
• Prepare, review, and submit regulatory dossiers and export documentation as per CDSCO, FDA, and importing country regulations.
• Handle product registration, export license applications, renewals, and variations for international markets.
• Coordinate with Indian regulatory authorities (CDSCO, State FDA) and overseas regulatory bodies for approvals and compliance.
• Ensure pharmaceutical products comply with destination country regulatory requirements.
• Manage documentation related to export such as COA, COPP, FSC, stability data, and technical dossiers.
• Respond to regulatory queries and deficiency letters from domestic and international authorities.
• Maintain updated regulatory and export compliance records.
• Support audits, inspections, and documentation reviews.
• Liaise with manufacturers, QA, Production, Logistics, and Marketing teams for regulatory alignment.
• Monitor regulatory timelines to ensure timely submissions and approvals for export consignments.
*Eligibility Criteria:*
• Bachelors / Master’s degree in Pharmacy, Life Sciences, or related field.
3–5 years of relevant experience in Regulatory Affairs (Pharma Export / Merchant Exporter preferred).
• Strong knowledge of CDSCO, FDA, DGFT, and international regulatory guidelines.
• Experience in CTD/ACTD dossier preparation for export market is must.
• Excellent documentation and communication skills.
• Strong attention to detail and deadline management.
• Ability to use translation tools/software to coordinate effectively with international clients and regulatory authorities.
• Flexibility in working hours to support coordination with overseas clients and regulatory bodies across different time zones.
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