Principal Scientist

Role & responsibilities

• Will be a part of R&D Biotech team
• The role involves supporting product development and ensuring compliance with global regulatory standards.
• Should have a thorough understanding of biosimilar CMC aspects - process and analytics
• Should 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 development
• Preparation of technical justifications/declaration to support regulatory submissions
• Author/drafting respective CMC sections of a CTD dossier in developed and emerging markets

Experience

Minimum 8-10 year experience in Biopharma R&D with exposure to regulatory query handling/ regulatory collaboration

Qualification

Ph.D in Biotechnology/ other life sciences from reputed university/institute

Accountabilities and Responsibilities

Will 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 interpretations
• Good oral and written communication skills
• Should be able to work in tandem with cross functional teams