Balaxi Pharmaceutical Limited Job Openings for Regulatory Affairs
We have urgent openings in Regulatory Affairs at Balaxi Pharmaceutical Limited at Hyderabad.
Department: Regulatory Affairs
Designation: Executive
Qualification: M.Pharm
Experience: 2 to 5 yrs
Job Location: Plot No.409, H. No: 8-2-293, MAPS Towers, 3rd Floor, Phase-III, Road No: 81, Jubilee Hills, Hyderabad, Telangana 500096.
Interested candidates Please share your Profiles to hr@balaxi.com
Job description:
Review of CMC (Chemistry Manufacturing and Controls) section of Drug substance and Drug Product
Responsible for Pre-Approval Life Cycle Management (Compile dossiers in CTD/ACTD/Country specific formats)
Post-Approval Life cycle Management (Quality-CMC/Variations/Renewals) for the marketing authorizations of Emerging Markets
CMC Renewal Dossier submission for LATAM, ASEAN, AFRICAN regions.
End to end knowledge on drug discovery and development Exposure on all dosage forms (Solids, Semi-solids, Injectable, liquid) including Medical devices
Handling queries related to dossiers from Regulatory authorities
Review of technical documents such as Analytical method validations, Product development report, process validation
reports, BMR, BPR, APR's, Annual reports, Stability Data and protocol, API, In Process, Finished Product and Excipients specifications
In-depth knowledge on general chapters of BP & USP Pharmacopeia
Review and approval of artworks including package inserts as per cGMP regulatory requirements
Initiation, review and approval of change controls related to Artworks
Good Comprehension on ICH-Good Clinical Practices (GCP) guidelines, Clinical trial phases, Patents
Collaborated with global colleagues and involved in Health Authority interactions
Review of Stability protocols and stability data
Preparation/Legalization process of Legal Documents like Manufacturing License, GMP certificate, FSC and CPP Knowledge on eCTD
Active co-ordination with F&D, Production, Quality Control, Quality Assurance, Packaging and IBD departments while
identifying discrepancies in technical data.
إرسال تعليق