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    Job · 22177013

    Airvin Skills logo

    Regulatory Affairs Associate

    Airvin Skills · Hyderabad · hybrid · Posted 1d ago

    Undisclosed0–1 yrsfulltimeSourced fromNaukri

    About a minute. You'll make an account on the way through.

    About this role

    Role & responsibilities


    A Regulatory Affairs Associate to support the regulatory affairs team in preparing and managing

    regulatory documentation and dossiers for product approvals.


    Key Responsibilities


    Assist in compilation of regulatory dossiers as per CTD/ACTD format

    Support preparation of regulatory documentation for submissions

    Track regulatory timelines and submission/approval status

    Coordinate with cross-functional teams (QA, R&D;) for document collection

    Maintain regulatory files and correspondence with authorities

    Support labelling and artwork review as per regulatory guidelines

    Stay updated with Pharma Regulatory guidelines and requirements


    Preferred candidate profile


    Basic knowledge of MS Office (Word, Excel, PowerPoint)

    Good written and verbal communication skills

    Attention to detail and documentation discipline

    Willingness to learn and work in a regulated, compliance-driven environment

    Sourced from naukri

    Skills

    BREAKTHRcompliance reviewpharmacovigilanceclinical trialsCRORegulatory AffairsSubmissionEctdregulatory submissionsUSFDARegulatory ReportsCTDoncologyadverse eventsDrug Regulatory AffairsPharmaceuticalLife Sciences

    Regulatory Affairs Associate · waiting for your command