Vacancies at Evolet Healthcare for Drug Regulatory Affairs
Post: DRA Executive / Assistant manager/ Manager
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No. of post: 2
Job Description
• Preparation of Dossiers - CTD ( Common Technical Dossier) and ACTD(Asian Common Technical Dossier).
• To do Gap Analysis & Reviewing documents received from plant QA/QC & maintaining records.
• To do Gap Analysis in the Loan License / Third party data for dossier requirement.
• Co-ordinating with plant - production & packing for samples and documents.
• Abreast with current guidelines of registration of different countries and share with team.
• Handling queries & deficiencies received from Authorities.
• Reviewing of documents received from CROs, FR&D ADL.
• Checking data like Stability, Specification & Standard Test Methods, Standard Operating Procedure, Certificate of Analysis, Checking MFR & BMR for correct calculations.
• Visiting Mfg. Plant for the data required for submission and interaction with QA/QC.
• Reviewing the dossiers prepared by team members before submitting to Authorities / Agent and taking the complete responsibility of error free dossiers.
• Regulatory work status to be maintained and weekly updates to be reported to HOD.
Additional Information
Experience: 4-7 years
Education: B.Pharm
Location: Gurgaon
Fucntional Area: DRA
Industry: Pharma/Biotech
Last Date: 15th August, 2017
Interested candidates can send their CVs at recruiter@evolet.in
Posted by,
Diksha,
Evolet Healthcare Pvt. Ltd.
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