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Urgent | Sr Executive Regulatory Affairs Labelling with Leading Pharma MNC in Ku

4.00 to 9.00 Years   Mumbai City   26 Dec, 2022
CERENTRAL CONSULTANTS PVT LTD Hiring For Multinational Pharma MNC at Kurla, Mumbai
Job LocationMumbai City
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaLegal Practice
EmploymentTypeFull-time

Job Description

    Designation: Sr Executive Regulatory Affairs LabellingReports to: Manager Regulatory AffairsShift: US EST Time ZoneKEY ROLES/RESPONSIBILITIES:Global labeling details (labels, cartons, package inserts, patient package inserts) to ensure quality andaccurate compliance, evaluations, maintenance, reviews and approvals with cross-functional teams forregulatory submissions. Preparation of Labelling related documents e.g. SmPC, PIL and Labelling texts for submission in EU region. Coordinating with the different stakeholders for timely labeling related submission/approval and querysolving. Proofreading all types of label copy/annotation/etc. at all developmental stages as well as final label copyto ensure accuracy of labeling. Creation of SPL for US Human and Vet product submissions, drug listing, annual establishment registrationand annual self-identification for GDUFA. Monitor and process innovator-labeling updates for existing generic products and ensure compliance withinnovator updates, including side-by-side comparison with RLDs. Responsible for coordination of CCDS development and updates of PCC products and coordination of locallabeling updates. Contribute to the development and/or review of all labeling aspects included in Promotional Material. Create/revise SOPs and work instructions for labeling (including global harmonization of labeling SOPs). Development and maintenance of a central repository for all labeling components.Software Handle: HARMONY SOFTWARE FOR REGULATORY AFFAIR LABELINGCountry Handle: EU, LATAM, ROW and US

Keyskills :
artworklabelscartonsregulatory affairslabelling

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