Senior Regulatory Affairs Officer Easebiz Fintech Solutions

5.0 - 10.0 years

3 - 8 Lacs

ahmedabad

Work from Office

Key Responsibilities Prepare, review, and submit CTD/ACTD/eCTD dossiers for international markets Develop and execute regulatory strategies for ROW, LATAM, SEA, Africa, and Pacific regions Manage product registration, renewals, variations, and post-approval compliance Ensure compliance with WHO-GMP, ICH, and country-specific regulatory guidelines Coordinate bioequivalence studies and relevant documentation Review technical files and maintain up-to-date regulatory documentation Liaise with regulatory authorities, internal departments, and external partners Mentor junior RA team members and drive process improvements Requirements B.Pharm / M.Pharm / Life Sciences background Minimum 6 years experience in Regulatory Affairs within the pharmaceutical industry Proficient in CTD/ACTD/eCTD dossier compilation Experience with parenteral dossiers (preferred) Exposure to global regulatory submissions and product lifecycle management Proficient in MS Office, with strong communication and leadership skills

Posted 12 hours ago

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