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    Job · 18857274

    Alcon logo

    Regulatory Operations - Regulatory Data Management Professional

    Alcon · Bengaluru · onsite · Posted 30d ago

    Undisclosed2–6 yrsfulltimeSourced fromNaukri

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

    About this role

    At Alcon, were passionate about enhancing sight and helping people see brilliantly. With more than 25,000 associates, we innovate fearlessly, champion progress, and act swiftly to impact global eye health. We foster an inclusive culture, recognizing your contributions and offering opportunities to grow your career like never before. Together, we make a difference in the lives of our patients and customers. Are you ready to join us

    This role is part of Alcons Quality & Regulatory Affairs function, a team that ensures our products are in compliance with global, local, and internal regulations and meet the strictest standards of quality as we help people see brilliantly.The Sr. Associate, Regulatory Operations (Professional Path) is primarily responsible for leading and completing compliance activities, including Change Control, Audit Management, and Quality Metrics. You will review regulatory documents and ensure adherence to audit schedules and regulations.

    Specifics Include:

    - Perform specialized tasks and conduct independent research to optimize outcomes for medical device and pharmaceutical products
    - Handle dossier preparation, Clinical Trial Disclosure, submission management, submission publishing, licensing, and labeling
    - Maintain up-to-date databases of submissions and approvals
    - Make decisions within the scope of assigned tasks to achieve project goals
    - Apply advanced knowledge, analytical skills, and self-direction
    - Adhere to GxP regulations by following Standard Operating Procedures (SOPs), maintaining accurate documentation, ensuring quality control, and completing required training
    - Contribute to the overall compliance of the organization and commit to continuous improvementAll associates must adhere to GxP regulations by strictly following Standard Operating Procedures (SOPs), maintaining accurate and complete documentation, ensuring rigorous quality control, and completing all required training. Associates are responsible for meeting their individual job requirements and contributing to the overall compliance of the organization. Compliance with regulatory requirements and a commitment to continuous improvement are essential to our operations .

    Qualifications: Associate shall have the appropriate education and experience to successfully perform the responsibilities/activities of this role.
    - Manage data entry, maintenance & registration hierarchy
    - Apply data quality & validation checks at point of collection
    - Define KPIs - cycle time, first-pass yield, on-time renewal
    - Monitor performance metrics & trends over time
    - Monitor dashboards & reports
    - Automate data workflows & trackers (PowerApps / Power Automate)
    - Perform data reconciliation
    ATTENTION: Current Alcon Employee/Contingent Worker
    If you are currently an active employee/contingent worker at Alcon, please click the appropriate link below to apply on the Internal Career site.
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    Alcon is an Equal Opportunity Employer and takes pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital status, disability, or any other reason.


    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

    data qualityDossieranalytical thinkingDossier PreparationPower automateChange Controldata reconciliationQuality ControlData ManagementoperationsmaintenanceAudit ManagementcomplianceData EntryPowerappsPharmaceutical

    About Alcon

    Alcon logo

    Alcon

    Medical Equipment

    2.2k+

    employees

    1945

    81 years old

    Fort Worth,Texas

    United States

    About

    A global leader in eye care, offering innovative surgical and vision care products while prioritizing research and development to meet evolving patient needs.

    Industries

    Medical EquipmentInternetAnalytics & KPO

    Employee ratings

    581 reviews

    3.8/ 5

    Culture

    3.7

    Career growth

    3.0

    Work-life

    3.8

    Employees rate it well for

    Work Life Balance71Work Culture67Senior Management50Salary48Job Security36

    Find them on

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    Regulatory Operations - Regulatory Data Management Professional · waiting for your command