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    Job · 20019186

    Apitoria Pharma logo

    Data Solutions Coordinator (Reg Intel) - India

    Apitoria Pharma · Bengaluru · onsite · Posted 20d ago

    Undisclosed4–9 yrsfulltimeSourced fromNaukri

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

    About this role

    Job Description
    The Role
    The Data Solutions Coordinator on the Regulatory Intelligence team at Redica Systems monitors global regulatory developments across 150+ countries. Responsibilities include identifying updates, assessing operational and strategic impact, determining industry scope, and ensuring accurate structured data entry in the regulatory intelligence platform. This role combines regulatory science, data structuring, and technology-enabled intelligence. Strong GxP knowledge, analytical judgment, and attention to detail are essential for this fast-paced, high-growth position.
    Key Responsibilities
    • Monitor global regulatory authorities (150+ countries) to identify relevant updates impacting Pharmaceutical, Biologics, MedTech, and Animal Health sectors.
    • Evaluate regulatory developments to determine industry scope and operational or strategic impact, distinguishing actionable changes from high-volume informational updates.
    • Classify and structure regulatory intelligence within the platform, including accurate industry and GxP tagging, metadata extraction (effective dates, consultation deadlines, enforcement timelines), and linkage of related regulatory documents.
    • Maintain awareness of evolving global regulatory frameworks, identify emerging trends, and collaborate with internal teams to refine monitoring scope and classification logic.
    • Ensure data accuracy and integrity through quality checks, KPI monitoring, and continuous improvement of regulatory intelligence workflows and structured data processes.
    About You
    • Communicates Effectively: Develops and delivers clear, concise communications across multiple platforms, ensuring accurate and timely sharing of regulatory intelligence insights, updates, and trends with teams and stakeholders.
    • Decision Quality: Demonstrates the ability to make good and timely decisions in data operations. Understands the implications of various data choices.
    • Optimizes Work Processes: Demonstrates the ability to enhance and streamline data processes. Seeks opportunities for data process improvement.
    • Business Insight: Demonstrates the understanding of the business and uses this knowledge to inform data decisions
    • Tech Savvy: Demonstrates a basic understanding of current technologies used in data operations. Can effectively use these technologies in daily work and is open to adopting new ones. Qualifications
    • 4 years experience in Regulatory Affairs, Quality Assurance, GxP, or Regulatory Intelligence within Pharmaceutical, Biologics, Medical Device, or Animal Health preferred.
    • Strong understanding of GxP principles and global regulatory frameworks, with the ability to interpret regulatory language and assess practical industry impact.
    • Experience analyzing regulatory updates or compliance-related materials.
    • A Master s degree (M.S.) in Regulatory Affairs, Pharmaceutics or Quality Assurance is preferred.


    Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

    Sourced from naukri

    Skills

    workflowsdata operationsRegulatory AffairsclassificationmetadataProcess ImprovementRegulatory FrameworksQuality AssuranceoperationscomplianceData EntryPharmaceutical

    About Apitoria Pharma

    Apitoria Pharma logo

    Apitoria Pharma

    Pharma

    7.3k+

    employees

    2023

    3 years old

    Hyderabad / Secunderabad, Telangana

    India

    About

    A top global API manufacturer, focused on producing Paracetamol while maintaining cost leadership through vertical integration in pharmaceuticals.

    Industries

    Pharma

    Employee ratings

    585 reviews

    4.2/ 5

    Culture

    4.0

    Career growth

    3.6

    Work-life

    4.2

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