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

Principal Scientist