The role includes managing regulatory affairs activities, preparing and reviewing regulatory documentation, and ensuring compliance with applicable regulatory requirements for clinical and healthcare-related products. The candidate will support regulatory submissions, maintain product registration records, coordinate with internal teams and regulatory authorities, and track changes in applicable regulations to ensure timely compliance.
Qualifications:
• Prepare, review, and maintain regulatory documents and submission dossiers.
• Support product registrations, renewals, and regulatory submissions.
• Ensure compliance with applicable regulatory guidelines and requirements.
• Maintain regulatory records, licenses, certificates, and documentation.
• Coordinate with internal teams and external regulatory authorities.
• Monitor regulatory updates and support the implementation of applicable changes.
• Assist with regulatory audits and responses to regulatory queries.
• Bachelor's or master's degree in Pharmacy, Life Sciences, Biotechnology, or a related field.
• Experience in Regulatory Affairs (RA), preferably in the pharmaceutical, medical device, or clinical healthcare industry.
• Knowledge of regulatory documentation, submissions, and compliance requirements.
• Solid documentation, communication, and coordination skills.
📌 Regulatory Affairs Associate (New Delhi)
🏢 Intrinseque Health
📍 New Delhi
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