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Senior Executive - DRA (Walk In Interview)

3.00 to 8.00 Years   Mumbai City   27 Mar, 2023
Job LocationMumbai City
EducationNot Mentioned
SalaryRs 3.5 - 4.5 Lakh/Yr
IndustryPharma / Biotech
Functional AreaOthers
EmploymentTypeFull-time

Job Description

    To be very well versed with registration, documentation filing with the MOH for herbal /pharma products particularly CIS and all other countries. (Formulation)Details:-
    1. To prepare Country specific dossiers in the format of CTD/ACTD and specific formats as per the respective countries guidelines
    2. Co-ordination with third party manufacturing facility . Collecting documents from third party manufacturers.
    3. To provide artwork text matter for preparing product label artworks.
    4. Follow-up for FDA licenses/COPP applications
    5. Responding to queries raised by MOH.
    6. Coordinate with plants to get the Dossiers/ Technical documents and samples of products for registration.
    7. To prepare raw data for the dossier.
    8. To fill the tender forms & providing requested documents
    9. Maintaining the registration data base country wise registered and Under registration
    10. Export COAs as per registered Specification
    11. Courier Documents for export.
    12. To do legalization documentation as per country requirement.
    13. Knowledge of new product development and quality assurance experience.

Keyskills :
artworkdratechnical documentationctddossier preparationdrug regulatory affairs

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