Piramal Pharma Solutions (PPS)
Designation : Executive
Function : RA
Functional Area : Regulatory Affairs
Job Role Summary : The role involves maintaining regulatory databases, supporting document compilation, and coordinating required documentation for regulatory submissions, amendments, and license applications with FDA and CDSCO.Â
Job Profile :
- Maintaining and updating database to track the submissions.
- Support for document compilation for Applicant's part.
- Preparation of Letter of Access.
- Collection of documents for Annual updates, Amendments and CEP Amendments.
- Collection of documents for License applications to FDA and CDSCO
Job Requirements :
- Understanding of regulatory documentation, license requirements, submissions
- Basic understanding of peptide synthesis principles is a plus.
Type of Experience : Regulatory submissions, licenses, handling Indian FDA, CDSCO,
Academic Qualifications :
- Masters/bachelor’s degree in chemistry or a related field.
