Garima Rawat
Senior Executive at Enzene Biosciences Ltd
Based in Pune, India
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Seniority
C-Team
Department
General Business & Management
Location
Pune
Industry
Biotechnology
Company size
946
Contact information
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g•••••••@enzene.com
Phone
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Background
About Garima Rawat
Accomplished Global Regulatory Affairs Professional specializing in the biopharmaceutical sector, offering extensive experience in regulatory submissions and related activities. Demonstrated expertise in navigating highly regulated markets, including the US and Europe, with successful submissions to USFDA, EMA, KFDA, and ANVISA. Proficient in managing individual sections of dossier writing for BLA, MAA, and DMF, as well as handling query responses and preparing IND, IMPD, scientific advice, and BPD packages. Skilled in ensuring compliance by interpreting regulatory guidelines and maintaining strict adherence to regulations. Experienced in fostering cross-functional collaborations to drive regulatory strategies and submissions. In addition to regulatory expertise, possesses a strong background in analytical methods, including HPLC, SDS-PAGE, cell-based bioassays, ELISA, and binding kinetics assays. Committed to maintaining the highest standards of compliance and quality in all regulatory activities.
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