Balaxi Pharmaceutical Limited Job Openings for Regulatory Affairs

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

Balaxi Pharmaceutical Limited Job Openings for Regulatory Affairs

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.