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Regulatory Affairs Officer

2.00 to 5.00 Years   Panchkula   28 Jun, 2022
Ind Swift Labs
Job LocationPanchkula
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaProductionQuality (QA-QC)
EmploymentTypeFull-time

Job Description

    Roles and Responsibilities1. Preparation and review of registration dossiers as per CTD/ACTD and country specific formats2. Review of quality documents like APIs DMF, Finished Product Specification, Certificate of Analysis, BMR, BPR, Process Validation and Stability etc. for guidelines Compliance3. Plan and coordinate with various departments like QA, QC and Production, to project the document requirements for appropriate submissions4. Co-ordination with clients for the tracking and status update of project plans5. Preparation of response to queries raised by regulatory authorities as well as by clients6. Preparation of Product Questionnaire, MAF and all related documents for bidding of international tenders7. Literature search/survey to compile clinical and non-clinical part within registration dossiers8. Preparation and review of SPC, Product monograph, package insert and labeling information9. Involved in drafting & review of applications for Product Approval, CPP, MMC, Non-Conviction Certificate and FSC10. Involved in preparation of renewal application for certificates like GMP, CPP, WHO-GMP, GLP & Non-Conviction CertificateDesired Candidate ProfileUS,EUGMP exposurePerks and BenefitsBest in industries,

Keyskills :
regulatory affairsdocumentationprocess validationvalidationlegal

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