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    Job · 19104117

    Sarjen Systems logo

    Hiring For Regulatory Affairs SME I Product Analyst | Pharma Domain

    Sarjen Systems · Ahmedabad · onsite · Posted 28d ago

    ₹4.0L - ₹8.0L PA3–7 yrsfulltimeSourced fromNaukri

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

    About this role

    - eCTD Submission Process
    - Regulatory Dossier Management
    - Pharma Software Product Analysis
    - Customer requirement analysis
    - Product demonstrations
    - Functional documentation
    - Regulatory process consulting
    - Regulatory Affairs

    Required Candidate profile

    - SPL (Structured Product Labeling) preparation and management
    - Regulatory variations, renewals, and lifecycle submissions
    - Act as Regulatory Affairs domain expert for software product development.

    Perks and benefits

    - 5 Days week
    - GPA & Term Plan
    - Flexible Time

    Sourced from naukri

    Skills

    DossierMHRAFDAEMAregulatoryRegulatory AffairsSubmissionEctdregulatory submissionsDossier PreparationUSFDARegulatory GuidelinesDossier CompilationActdICHRACTDRowRegulatory ComplianceProduct ManagementFormulationDrug Regulatory Affairs

    About Sarjen Systems

    Sarjen Systems logo

    Sarjen Systems

    IT Services & Consulting

    75

    employees

    1998

    28 years old

    Ahmedabad, Gujarat

    India

    ₹5.5L PA avg

    Avg at Sarjen Systems

    ₹4L – ₹8L PA

    This role

    About

    Sarjen provides business and GxP compliant software solutions, services across several industry domains including Pharmaceutical, Healthcare, etc.

    Industries

    IT Services & Consulting

    Employee ratings

    10 reviews

    3.7/ 5

    Culture

    2.8

    Career growth

    2.4

    Work-life

    3.5

    Employees rate it well for

    Job Security40Work-Life Balance39

    Find them on

    WebsiteLinkedInAmbitionBox reviews

    Hiring For Regulatory Affairs SME I Product Analyst | Pharma Domain · waiting for your command