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Ind-Swift-Laboratories Ltd. Hiring for Drug Regulatory Affairs- Executive/ Officer/ Sr. Officer – Panchkula & Gurugram location
OPEN POSITIONS
for Formulation Site
Drug Regulatory Affairs Executive/Officer/Sr. Officer
B Pharma/ M Pharma with 3-5 years of experience
Location: Panchkula (3) & Gurugram (3)
Responsibilities :
1. Preparation and review of registration dossiers as per CTD/ACTD and country specific formats.
2 Review of quality documents like API’s DMF, Finished Product Specification, Certificate of Analysis, BMR, BPR. Process Validation and Stability etc. for guidelines Compliance.
3. Plan and coordinate with various departments like QA, QC and Production, to project the document requirements for appropriate submissions
4 Co-ordination with clients for the tracking and status update of project plans. eries raised 5. Preparation of response to queries I by regulatory authorities as well as by clients.
6. Preparation of Product Questionnaire, MAF and all related documents for bidding of international tenders. 7. Literature search/survey to compile clinical and non-clinical part within registration dossiers.
8. Preparation and review of SPC, Product monograph, package insert and labeling information. 9. Involved in drafting & review of applications for Product Approval, CPP, MMC, Non-Conviction Certificate and FSC
10. Involved in preparation of renewal application for certificates like GMP, CPP WHO-GMP, GLP & Non- Conviction Certificate
Note : Only MHRA, EU GMP & ROW exposure candidates will be entertained.
Positions open in Drug Regulatory Affairs. Candidate can contact at +91-7087978441. Location Gurugram and Panchkula
