Managed regulatory submissions for product approvals in international markets, ensuring timely clearances.
Verified product labels for accurate claims, ingredient lists, and compliance with regulatory standards.
Coordinated with regulatory authorities to resolve queries and expedite product registrations.
Assisted in the preparation and management of Quality Control Documentation, ensuring compliance with GMP and regulatory guidelines.
Gained hands-on experience in compiling regulatory dossiers, including CMC (Chemistry, Manufacturing, and Controls) sections.
Reviewed and organized documents related to batch records, deviations, and change control.
Manage the preparation of full ACTD dossiers, compiling all required documents according to the ASEAN Common Technical Dossier format. Ensure each section meets regional requirements, including quality, safety, efficacy, and manufacturing information.
Maintain regulatory databases, track submissions,



and ensure proper documentation management.
Develop and implement regulatory strategies for pharmaceutical and nutraceutical products.
Keep up to date with changing regulations and interpret their impact on products.
Manage submissions such as DMFs (Drug Master Files), CTDs (Common Technical Documents), GRAS (Generally Recognized as Protected) dossiers, and other regulatory documentation.
Ensure accuracy and compliance of product labeling, packaging, and promotional materials.
Review ingredient lists, claims, and formulations for regulatory compliance. 15. Maintain regulatory databases, technical files, and compliance records. 16. Monitor and ensure compliance with pharmacovigilance, nutravigilance, and post-market reporting requirements.

Pay: ₹25,000.00 - ₹45,000.00 per month

Work Location: In person

📌 Regulatory Affairs Executive Makarba
🏢 Kaamlo Platform Private
📍 Makarba