Regulatory Operations Associate
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Results-driven regulatory affairs professional with 6+ years of experience in pharmaceutical and CRO sectors. Skilled in ICH guidelines and regulatory compliance, ensuring successful submissions and global standards adherence. Passionate about expanding expertise and contributing to a compliance driven environment.
Regulatory Operations Associate II | Fortrea | July 2020 – Present (≈5.5+ years)
Working in regulatory operations with focus on CMC documentation, post-approval changes, and regulatory compliance for US and EU markets. Responsible for compiling and reviewing regulatory submissions, assessing regulatory impact of changes, managing change control, coordinating with cross-functional teams, and handling documents in EDMS in line with ICH, USP, and EP requirements.
Quality Assurance Officer | Mexfluor India Pvt. Ltd. | June 2019 – March 2020 (≈10 months)
Supported pharmaceutical quality systems by implementing QMS, preparing and maintaining SOPs and BMRs, conducting internal audits, coordinating external audits, ensuring cGMP compliance, and managing training, calibration, and preventive maintenance activities.
Total Experience: ~6+ years in Pharmaceutical Regulatory Operations and Quality Assurance.
Master of Pharmacy (M.Pharm) | Bharati Vidyapeeth (Deemed to be University), Pune | 2017 – 2019
Specialized postgraduate education with strong focus on pharmaceutical sciences, regulatory concepts, and quality standards relevant to regulatory affairs and compliance.
Bachelor of Pharmacy (B.Pharm) | University of Mumbai | 2013 – 2017
Comprehensive foundation in pharmaceutical sciences, including drug development, manufacturing, quality assurance, and regulatory fundamentals.
