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Senior Regulatory Affairs Associate

3.00 to 11.00 Years   Chennai   18 Oct, 2022
PAREXEL International
Job LocationChennai
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaFinance / Accounts / Tax
EmploymentTypeFull-time

Job Description

    • Relevant experience in regulatory package preparation, compilation and submission to Health Authorities in various markets with focus on EU countries.
    • Working knowledge of EU regulatory procedures including adaptability to strict Health Authority and Sponsor timelines for completing submissions
    • Knowledge of EU country regulations
    • Able to contribute as local SME for countries and collaborate with global team and other stake holders for increasingly more complex regulatory submissions for Clinical Trial Applications.
    • Experience in handling health authority queries
    • Good understanding and knowledge of ICH guidelines and Ethics Committee requirements for Clinical Trial Applications in EU countries.
    • Clear oral and written communication skills
    • Acceptability towards varied cultural mindsets to collaborate efficiently with client counterparts and other internal stakeholders as well
    • Execute and maintain submission delivery plans, submission content plans, and proactively provide status updates to designated stakeholders.
    • Strong communications skills and ability to guide and mentor team members.
    • Ability to work in different time zones
    Ability to work independently#LI-REMOTE,

Keyskills :
clinical trialsdocumentationapacdcgisopwritten communicationregulatory submissionsclinical trialsmeichethicsclinicalregulatorymilestonesregulationspreparationcompilation

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