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    Regulatory Affairs Global Labeling Lead

    Iqvia
    5+ years
    preferred by company
    Bengaluru
    13 Nov. 23, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Title: Regulatory Affairs Global Labeling Lead

    Job Summary

    As a Regulatory Affairs Global Labeling Lead, you will oversee all labeling activities for specified Active Pharmaceutical Ingredients (APIs). You will collaborate with clients and IQVIA stakeholders, including Global Labeling, Pharmacovigilance (PV), Global Regulatory Leads (GRLs), and Local Operating Companies (LOCs), to ensure regulatory compliance.

    Key Responsibilities

    1. Labeling Development and Management

      • Lead the creation and management of core and regional labeling documents throughout the product lifecycle, including:
        • Company Core Data Sheet (CCDS)
        • European Summary of Product Characteristics (EU SmPC)
        • United States Package Insert (USPI)
        • Patient labels
      • Ensure compliance with regulatory policies and company procedures.

    2. Cross-Functional Leadership

      • Organize and lead Labeling Working Group (LWG) meetings involving experts from:
        • Regulatory Affairs (RA)
        • Clinical
        • Safety
        • Medical
        • Non-clinical
        • Regulatory Chemistry, Manufacturing, and Controls (Reg CMC)
      • Evaluate the impact of regional/local labeling changes on the CCDS and achieve consensus on global labeling matters.
      • Document, archive, and communicate LWG decisions, ensuring senior management endorsement.

    3. Regional and Local Labeling Coordination

      • Manage local labeling deviations and exceptions with regional/local regulatory leads.
      • Support the development of labels for first-to-file submissions outside the EU and US.
      • Align local labels with CCDS and ensure timely implementation of updates.

    4. Compliance and Systems Management

      • Maintain labeling compliance in:
        • Electronic Document Management Systems (EDMS)
        • Regulatory Tracking Systems
      • Manage Electronic Drug Registration and Listing Systems (eDRLS) in the US.

    5. Operations and Deliverables

      • Collaborate with Labeling Operations Coordinators (LOCs) as needed.
      • Ensure timely delivery of all labeling-related tasks and conduct quality control (QC) reviews for other Global Labeling Leads (GLLs).

    Qualifications and Skills

    • Experience

      • Regulatory labeling experience in the EMEA and North America regions is essential.
      • At least 5 years of pharmaceutical Regulatory Affairs experience in the pharmaceutical industry.

    • Education

      • Pharmacy graduate or a degree in life sciences.

    • Skills

      • Excellent written and verbal communication skills in English.
      • Proficiency in one or more additional European languages (e.g., Polish, Hungarian, German, Portuguese, Spanish, Romanian).
      • Strong ability to communicate complex regulatory information to diverse stakeholders.

    Other Requirements

    • Ability to meet deadlines and deliver quality results consistently.
    • Proven organizational and coordination skills in cross-functional environments.

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