Zydus Cadila, a leading Indian Pharmaceutical company is a fully integrated, global healthcare provider. With in-depth domain expertise in the field of healthcare, it has strong capabilities across the spectrum of the pharmaceutical value chain.
Post : Regulatory Affairs - Vaccines & Diagnostics Manager
Job Description
With 10-20 years of relevant experience. The job requires to understand national and international regulatory guidelines and requirements and procedure for filing applications and the dossier in CTD format, to review dossier for Phase I, II & III clinical trial and marketing authorization and submission online on SUGAM portal for vaccines. Candidates should be well versed with the SUGAM-CDSCO online portal.
The job also requires regulatory awareness of difference in medical devices & in-vitro diagnostic kits, awareness of required QMS documentations and its implementation with gap analysis, transition awareness from FDA to MDR 2017 for medical devices and classification awareness of in- vitro diagnostics, to collaborate with cross functional stake holders for smooth on time applications / dossier submissions, to coordinate with business development for business expansion by strategy preparation to target new regulated markets, to provide regulatory support in product & process development strategy preparation, to review & submit of recombinant product dossier (Form B1. Form B3, Form B5, Form B7. Form C1, Form C3 & Form C5) to IBSC & RCGM.
Further the job consists of preparation & submission of post approval changes, review of change controls as per regulatory requirements, to respond the queries from MOH post submissions as per the timelines given by the respective regulatory authorities, to perform gap analysis for the available documents for regulatory adequacy and have knowledge for loan / contract manufacturing license application submission.
Job Location : Gujarat
Interested candidates can share their updated CV to Rachana.narayan@zyduscadila.com / arti.thaker@zyduscadila.com
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