Navi Mumbai, Maharashtra, India
Regulatory Affairs professional with over 15 years of experience in the pharmaceutical industry, currently serving as Senior Manager Regulatory Affairs at Rubicon Research Limited. Brings a strong focus on regulatory strategy, compliance, and documentation to support the development and approval of pharmaceutical products in alignment with global standards. Proficient in managing regulatory timelines, data retention, and document preparation, including CTD, ACTD, and variation filings. Committed to ensuring adherence to regulatory guidelines, maintaining product lifecycle requirements, and collaborating effectively with agencies and clients to achieve successful regulatory outcomes.
Drug Registration, CTD, ACTD, Variation, Product life Cycle Management, Communication to agency and client,Response to agency, Change Control, communicaStandard Operating Procedure, Country registration requirement, regulatory requirement formulation
Dossier preparation, CTD, ACTD, Variation Filing, Plant Co-ordination, response to the queries
Drug Registration, CTD, ACTD, Country Specific Requirements,
Bioequivalence Studies