Torrent Pharma R&D are hiring for Supervisor- Regulatory Affairs – Biosimilars
We at Torrent Pharma R&D are hiring for Supervisor- Regulatory Affairs – Biosimilars
Position: MGR/ Sr. MGR
Job Responsibility:
Regulatory filing for Biosimilars as per CTD/ACTD, PAC, PSUR & query compliance for DCGI, EU & Semi regulated market.
Managing RA Life cycle projects including records, overall strategy, regulatory filing documents for regulatory submission at DCGI and Global markets
Responding to technical queries related to product registration raised by Domestic/International drug authority/ Distributor/ LTR
Review New Project data site plan, QMS data and other technical documents for regulatory submission domestic as well as global markets
Information Management System, RA Life cycle documentation with c GMP requirement, SAP Operations.
Point of Contact with various International regulatory authorities.
Qualification & Experience: M.Pharma/ MSc/Ph.D with 10-12 years of relevant experience
Location: R&D Center (Gandhinagar)
Interested candidates may share their CVs on [email protected]
