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Drug Regulatory Affair

3.00 to 8.00 Years   Delhi   31 Dec, 2024
Job LocationDelhi
EducationNot Mentioned
SalaryRs 3.0 - 6 Lakh/Yr
IndustryPharma / Biotech
Functional AreaQuality (QA-QC)
EmploymentTypeFull-time

Job Description

    Hiring Manager DRA (Drug Regulatory Affair) with one of established pharmaceutical company based at Shivaji Marg New Delhi.Position- Manager DRAQualification- B.Pharm, M.Pharm Experience- 5-10 years Salary- 40-50k (Negotiable)Responsibilities:Well versed in management of Dossier Preparation (documentation) in CTD Format for ROW, CIS, AFRICAN AND LATAM countries and quality issued through various quality management (Mandate) Preparing documents to support dossier if required like finished products specifications, AMV, DMF, Finished Product COA, and Stability Study. Exp professional in supplier quality management documentation in medical, pharma industry. Excellent team Coordination skills Experience in handling complex quality problems, Troubleshoot quality/compliance issue using experience and creativity to provide solution to a wide range of root causes towards dossier queries from clients from different country under their regulatory guidelines. Full awareness of end to end supplier quality Management include supplier selection, qualification, performance management, ASL Management, change control management, Nonconformance management, CAPA management, COPP and Product Permissions requirements, paper based audit management, quality agreement management Review product records to confirm that Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP) requirements are met. And to vet the document by 100% Proofing. Good analytical skills Understanding of regulatory requirements for various Consumer/pharmaceutical products. Able to handle supplier communication for providing end resolution simultaneously. Please Share your cv with below details Current CTCExpected CTCNotice Period--RegardsShweta Lead Recruiter HR Notionresume.hrn@gmail.comhidden_mobile

Keyskills :
dossier preparationregulatory affairs

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