Job Title

Role & responsibilities Will be a part of R&D Biotech teamThe role involves supporting product development and ensuring compliance with global regulatory standards.Should have a thorough understanding of biosimilar CMC aspects - process and analyticsShould be updated with latest developments in various regulatory guidelines related to CMC across geographies (RoW, EMA, ANVISA, USFDA, PMDA etc)Will be responsible to provide technical support for regulatory queries for product registration and variation filings.Authoring of query responses related to product characterization and process/ product developmentPreparation of technical justifications/declaration to support regulatory submissionsAuthor/drafting respective CMC sections of a CTD dossier in developed and emerging marketsExperienceMinimum 8-10 year experience in Biopharma R&D with exposure to regulatory query handling/ regulatory collaboration QualificationPh.D in Biotechnology/ other life sciences from reputed university/institute Accountabilities and ResponsibilitiesWill function as a R&D expert for RA deliverables like support for dossier authoring, query responses etc.Competencies Proficiency on MS office, sound knowledge of statistical data analysis and interpretationsGood oral and written communication skillsShould be able to work in tandem with cross functional teams