Job Description:

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    About the Role

    Abbott's Established Pharma Division (EPD) is seeking a detail-oriented and process-driven professional to join its Regulatory Operations team. This role focuses on regulatory document management, compliance support, data accuracy, and coordination across regulatory functions to ensure timely and efficient regulatory operations.

    Key Responsibilities

    • Process, review, and manage regulatory and pharmaceutical documents using Document Management Systems (DMS) and Regulatory Information Management Systems (RIMS).

    • Maintain accurate regulatory records, document inventories, and submission-related documentation.

    • Perform quality checks on documents to ensure compliance with internal procedures and regulatory requirements.

    • Coordinate with Regulatory Affairs, Operations, and Publishing teams to support submission readiness and meet project timelines.

    • Upload, track, and maintain regulatory documents within RIMS and DMS platforms.

    • Manage MRP and PSP inventories and support Quality Management (QM) document coordination activities.

    • Assist in resolving process and system-related issues while supporting continuous improvement initiatives.

    • Contribute to departmental projects, operational excellence activities, and process standardization efforts.

    • Support training initiatives by assisting in the development of training materials and operational guidelines.

    • Provide guidance and support to junior team members when required.

    Preferred Qualifications

    • Experience in Regulatory Operations, Regulatory Affairs support, Documentation Management, or Pharmaceutical Operations.

    • Familiarity with DMS, RIMS, or similar document management systems.

    • Strong attention to detail and organizational skills.

    • Good communication and stakeholder coordination abilities.

    • Publishing/eCTD experience is beneficial but not mandatory.

    Work Details

    • Working Days: Monday to Friday

    • Work Timings: 8:30 AM – 5:00 PM

    • Occasional extended hours may be required to support business-critical activities.

    • Leave & Benefits: As per company policy.
      
      

    for more details connect  - Pranali Pawar
    Associate – HR & Recruitment
    📱 +91 7738511752
    📧 hiring@talismanstaffing.com