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Regulatory Affairs Officer

1.00 to 3.00 Years   Mumbai City   06 Feb, 2024
Roche International Hiring For pharma EYE health company
Job LocationMumbai City
EducationNot Mentioned
SalaryRs 1.0 - 3.5 Lakh/Yr
IndustryPharma / Biotech
Functional AreaProduct Management
EmploymentTypeFull-time

Job Description

    Please find JD for Regulatory Affairs:1. Preparation of Dossier in CTD, ACTD and country specific format.2. Resolving queries received from various Ministry of Health.3. Preparation of Technical master file for Medical Device.4. Finalization of Artwork as per Country specific guidelines.5.Co-ordination with vendors for DMF and API related data.6. Review of documents received from various departments.7. Sample preparation as per countryguidelines.

Keyskills :
preparation of technical master file for medical device.dossier in ctd actdrow market in formulationfinalization of artwork as per country specific guidelines.

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