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    Job · 10920513

    parexel international logo

    Regulatory Affairs Associate

    parexel international · Remote · onsite · Posted 71d ago

    Undisclosed6–6 yrsfulltimeSourced fromNaukri

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

    About this role

    When our values align, there's no limit to what we can achieve.
     
    At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

    Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

    We are seeking a detail-oriented Regulatory Affairs Specialist with 3+ yrs experience in post-approval regulatory activities for medicinal products registered through European procedures (CP, MRP, DCP, and National Procedures). The successful candidate will support lifecycle management activities, regulatory submissions, CMC documentation updates, and health authority interactions while ensuring compliance with applicable regulatory requirements.
    Key Responsibilities
    • Perform Regulatory Impact Assessments (RIA) for Change Controls raised in TrackWise.
    • Assess regulatory implications of manufacturing, quality, labeling, and product information changes.
    • Manage and maintain regulatory change records within Veeva RIMS.
    • Support implementation of regulatory strategies for post-approval changes.
    • Review, update, and author Module 3 sections of CTD dossiers for medicinal products.
    • Ensure CMC documentation remains current and compliant with regulatory expectations.
    • Support dossier lifecycle maintenance activities across multiple markets.
    • Conduct comprehensive Gap Analysis of Module 3 documentation.
    • Identify compliance risks, data gaps, and documentation deficiencies.
    • Develop and recommend remediation plans and regulatory strategies to address identified gaps.
    • Manage post-approval regulatory activities throughout the product lifecycle.
    • Support maintenance of marketing authorizations across EU markets.
    • Collaborate with cross-functional teams to ensure timely execution of regulatory commitments.

    Sourced from naukri

    Skills

    Dossierclinical researchclinical trialsregulatoryRegulatory AffairsEctdregulatory submissionsregulatory requirementsLabelsCMCUSFDAVEEVAChange Controlclinical developmentandaICHRACTDRimPostDMFDocumentationcompliancePharmaceutical

    About Parexel International

    parexel international logo

    parexel international

    Clinical Research

    5.8k+

    employees

    1982

    44 years old

    Raleigh, NC

    United States

    ₹8.1L PA avg

    Avg at Parexel International

    About

    Parexel is a trusted global clinical research organization (CRO) and biopharmaceutical services company.

    Industries

    Clinical ResearchHealthcare / PharmaManufacturingAnalytics & KPOPharma

    Employee ratings

    10 reviews

    3.8/ 5

    Culture

    3.3

    Career growth

    2.3

    Work-life

    3.8

    Employees rate it well for

    Company Culture38Overall Company38

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