Hiring for CMC - Regulatory Affairs - EU Market (formulations) Hyderabad for Exp. 2 - 5 Years at Aurobindo Pharma Ltd.
MedWiz Mumbai, Maharashtra, India
Jan 10, 2019Full time
Job Description:1.Major duties in Post approval life cycle management for the submissions of oral solid and liquid dosage forms in European union 2.Review of TTD documents such as Specifications (API, FP, Excipients, Packing materials), Product development report, stability protocols, dissolution protocols, packing plan etc. 3.Compilation of updated dossier (for APL & Customers) & responding to agency comments (MRP/DCP/National) 4.Preparing quality overall summary for Renewal filings 5.Product approval package preparation & Circulation of approved specifications 6.Preparation of variation packages & tracking of EP monograph updates 7.Review of change controls 8.Maintenance of status (Customer status, DCP-MRP & Renewal time table, Variations, Batch sizes, shelf life, CEP & Audit status etc.)