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Associate Director

9.00 to 12.00 Years   Chennai, Noida, Hyderabad, Gurugram   01 Jul, 2022
Acura Solutions
Job LocationChennai, Noida, Hyderabad, Gurugram
EducationNot Mentioned
SalaryNot Disclosed
IndustryMedical / Healthcare
Functional AreaIT Operations / EDP / MIS
EmploymentTypeFull-time

Job Description

    Dear candidate ,We are hiring for Associate Director Work Experience Required : 9+YearsLocations : HybridRequired knowledge, skills and abilities
    • Experience in driving Labelling Centre of Excellence vision and goals
    • Subject Matter Expert in pharmaceutical product labelling
    • Ability to provide strategic input to develop technology-enabled labelling services
    • Ability to provide strategic input to expand GRA labelling capabilities
    • Ability to provide strategic input based on planned and draft regulatory changes related to labelling (e.g. move to electronic Product Information)
    • Proven expertise in global labelling processes (including European Centralised, Mutual Recognition and Decentralised Procedure requirements for MAAs and variations) from initial change request through to implementation in the local market
    • Proven expertise in global labelling outputs, including Company Core Data Sheets (CCDS),
    • justification document, Reference Safety Information (RSI), basis and reference labels, core and local labelling including artwork
    • Proven expertise in CTD Module 1 Product Information and Module 2.5 (clinical overviewaddendum)
    • Proven expertise and experience in chairing Global Labelling Committee meetings for the review of CCDS and RSI
    • Good understanding of US labelling requirements, including SPL format
    • Good understanding of process for preparation of initial CCDS from clinical trial data and Target
    • product profile
    • Good understanding of pharmacovigilance activities related to Reference Safety Information for
    • marketed products
    • Proven expertise for regulatory review of promotional material (AdPromo) for local market
    • Prepare and provide labelling training, including AdPromo for both regulatory and medical reviewers
    • Preferably, experience in labelling technology systems e.g. ZINC for AdPromo review and approval, RIM system with Labelling Module
    • Line Manager for supporting global labelling strategic projects
    RegardsHR

Keyskills :
labelsregulatory affairs

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