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Regulatory Affairs at Navi Mumbai-Sanpada .

1.00 to 6.00 Years   Navi Mumbai   13 Mar, 2023
Job Search Hiring For Pharma Company
Job LocationNavi Mumbai
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaPharmacist / Medical Representative
EmploymentTypeFull-time

Job Description

    Urgent requirement forRegulatory Affairs at Navi Mumbai-Sanpada .Industry: Pharma CompanyExperience: 1 year aboveJob profile:
    • Management of regulatory submissions for Regulated / ROW markets for formulations.
    • Preparation, review and submission of country specific registration dossiers in high quality CTD/eCTD/NeeS in all modules (m1-m5) for regulatory submission.
    • Product life cycle management, renewals and submission of post approval variations to the marketing authorization.
    • In-depth with global regulatory guidelines & requirements, to formulate strategies.
    • Review, GAP analysis and update Developmental, CMC, Quality, BE, Waiver documents in line with the expectation of regulatory agencies.
    • To prepare timely & effective responses to queries raised by the regulatory agency.
    • To coordinate with cross functional teams with QA, QC, Validations, R&D, Production etc.
    • To coordinate with global vendors for regulatory compliance of dossiers for submission.
    • Application of Product Permissions, COPPs, and coordination for addition of New Products in WHO GMP List
    • Ensuring samples are sent timely and coordinating with concerned person for submission, getting the receipts and follow-up on the registrations.
    • Checking of Artwork, Leaflets of both International and Domestic Supplies.
    If you are interested for the above referred position, kindly revert back with your Updated Resume with Photograph along with following details:1) Current salary2) Expected salary3) Notice period4) Total experience5) Relevant experience6) Current location7) Reason for job changeContact no.:- Pratima- hidden_mobileMail ID:hidden_email

Keyskills :
gap analysisregulatory complianceregulatory affairsrow markets

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Regulatory Affairs at Navi Mumbai-Sanpada . Related Jobs

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