Recruitment for DRA Executive/Manager at Evolet Healthcare | 02 posts
Evolet Healthcare Pvt. Ltd. has long-term contracts with manufacturers of pharmaceutical products as well as with international pharmaceutical corporations and marketing companies that distribute its products in the markets of Asia, EU, CIS, Africa and Latin America.
Post: DRA Manager
No. of post: 02
• 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.
Experience: 1-7 years
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Regulatory Affairs Manager
Last Date: 5th Feb., 2017
Interested candidates can send their CVs at firstname.lastname@example.org
Evolet Healthcare Pvt. Ltd.
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