Cureton Biotech
Website:
cureton.in
Job details:
Job Location: Okhla Industrial Area Phase – 1, New Delhi
Employment Type: Full Time | On-Site
Salary: 40K -55K Per Month
Experience required: 5–6 Years (Pharma Industry / Export Documentation)
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Job Summary:
We are looking for a skilled and detail-oriented Regulatory Affairs Executive with hands-on experience in CTD/ACTD dossier preparation and exposure to Latin America (LATAM) regulatory markets.
The candidate will be responsible for managing end-to-end regulatory activities including dossier preparation, submission, product registration, and coordination with international regulatory authorities to ensure compliance with export market requirements.
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Key Responsibilities:
Prepare, compile, and review CTD / ACTD dossiers for international markets (LATAM preferred).
Handle product registration, renewals, and variations for export markets, especially Latin America countries
Coordinate with international regulatory authorities for dossier submission, approvals, and compliance and quarries resolution.
Ensure compliance with importing country regulations (LATAM, ROW markets)
Manage and maintain regulatory documentation such as COA, COPP, FSC, stability data, and technical dossiers
Respond to regulatory queries, deficiency letters, and audit observations from global authorities
Work closely with manufacturers and internal teams for data collection and dossier compilation
Track regulatory timelines to ensure on-time submissions and approvals
Maintain accurate and updated records of all regulatory submissions and approvals
Support internal and external audits, inspections, and documentation reviews
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.
Ready to Apply?
Please send your resume to hr.curetonbiotech@gmail.com with "Regulatory Affairs Executive" in the subject line.
Click on Apply to know more.