Ind-Swift
Join Our Team
Executive/Officer/Sr. Officer
Drug Regulatory Affairs
for R&D Centre Panchkula
B.Pharma/M.Pharma with 3-5 years of experience of Regulatory Markets (EU/MHRA/USFDA)
Responsibilities:
•Preparation and review of registration dossiers as per CTD/ACTD and country-specific formats.
•Review of quality documents like API’s DMF, Finished Product Specification, Certificate of Analysis, BMR, BPR, Process Validation and Stability etc. for guidelines compliance.
•Plan and coordinate with various departments like QA, QC and Production, to project the document requirements for appropriate submissions.
•Co-ordination with clients for the tracking and status update of project plans.
•Preparation of response to queries raised by regulatory authorities as well as by clients.
•Preparation of Product Questionnaire, MAF and all related documents for bidding of international tenders.
•Literature search/survey to compile clinical and non-clinical part within registration dossiers.
•Preparation and review of SPC, Product monograph, package insert and labeling information.
•Involved in drafting & review of applications for Product Approval, CPP, MMC, Non-Conviction Certificate and FSC.
•Involved in preparation of renewal application for certificates like GMP, CPP, WHO-GMP, GLP & Non-Conviction Certificate.
Send Your Resume:
Email: [email protected]
Contact: 70879 78441
