Agent
Jobs
Applied
Tracker
Profile
    1. Jobs for you
    2. Job

    Job · 21680241

    MUMBAI · FULLTIME

    Regulatory Affairs Associate

    Airvin Skills

    Airvin Skills

    Mumbai · hybrid · Posted 1d ago

    Sourced fromNaukri
    Undisclosed0–1 yrsfulltimeMumbai

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

    agent · working

    • Read this posting0.6s
    • Found the form on Naukri · 10 questions to answer1.8s
    • Decided the answers for all of them2.2s
    • Tailor your résumé to this role
    • Waiting for you

    Section · 01

    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

    Section · 02

    Skills

    clinical data managementpharmacovigilanceclinical trialspharmacologyDrug safetymedical affairsmedical writingscientific writingpharmaceuticsRegulatory AffairsICH-GCPClinical Operationsclinical developmentoncologyDrug Regulatory AffairsLife Sciences

    Regulatory Affairs Associate · waiting for your command