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Business: PPL
Department: Regulatory Affairs
Location: Navi Mumbai
Travel: Low
The role involves maintaining regulatory databases, supporting document compilation, and coordinating required documentation for regulatory submissions, amendments, and license applications with FDA and CDSCO. The position also includes preparing Letters of Access and performing other duties as assigned by the Head of Department.
Key Responsibilities:
Preferred candidate profile:
Piramal Pharma Solutions (PPS) is a Contract Development and Manufacturing Organization (CDMO) offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our customers through a globally integrated network of facilities in North America, Europe, and Asia. This enables us to offer a comprehensive range of services including drug discovery solutions, process & pharmaceutical development services, clinical trial supplies, commercial supply of APIs, and finished dosage forms. We also offer specialized services such as the development and manufacture of highly potent APIs, antibody-drug conjugations, sterile fill/finish, peptide products & services, and potent solid oral drug products. PPS also offers development and manufacturing services for biologics including vaccines, gene therapies, and monoclonal antibodies, made possible through Piramal Pharma Limited's investment in Yapan Bio Private Limited. Our track record as a trusted service provider with experience across varied technologies makes us a partner of choice for innovators and generic companies worldwide.
Job ID: 140924043
