Regulatory Affairs Officer
Job Description
Preparation & Review of Dossiers in ACTD, CTD or Country specific format for ROW market.Preparation and submission of Site GMP Application, Product Registration Applications with respective Regulatory Authorities.Liasoning with Local FDA for Product Permission, FSC, COPP etc. & CDSCO for inclusion of COPP.Coordination with QA/QC departments for technical/legal documents.Artwork designing for registration sample preparation and submissionPreparation and/or review of technical documents such as BMR, PVP/PVR, Specification, MOA, COA of raw material, finished product and packing materials and all other documents for compilation of dossiers.Documents preparation for bidding in National & International TendersMOH query response and resolution within stipulated timelineJob Type: Full-timePay: ?200,000.00 - ?350,000.00 per yearBenefits:
- Provident Fund
- Day shift
- bodakdev, Ahmedabad, Gujarat: Reliably commute or planning to relocate before starting work (Required)
- total work: 1 year (Preferred)
+91 9898033626
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Job Detail
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Job IdJD2902971
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IndustryNot mentioned
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Total Positions1
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Job Type:Full Time
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Salary:Not mentioned
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Employment StatusPermanent
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Job LocationAhmedabad, Gujarat, India
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EducationNot mentioned
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ExperienceYear