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    Regulatory System Associate

    Haleon
    0-5 years
    Not Disclosed
    Hyderabad
    10 May 3, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Communication Skills, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Title: Regulatory Information Management (RIM) System Manager

    Job Purpose:
    The purpose of this role is to oversee the regulatory information management (RIM) system for all Consumer Healthcare products globally. This involves managing regulatory processes to ensure compliance with legal and pharmacovigilance obligations. The role includes operating regulatory systems, preparing and storing regulatory submissions, managing labeling, tracking compliance, and generating reports. Close collaboration with internal and external stakeholders is essential to meet compliance requirements and enhance efficiency through system optimization.

    Key Responsibilities:

    1. System Administration:

      • Identify and drive system or process enhancements to improve data quality, user experience, and compliance.
      • Provide guidance and support for system upgrades and changes.
      • Monitor system performance and resolve issues promptly.
      • Collaborate with IT on system implementation and change control activities.

    2. System Reports:

      • Manage the design, validation, and delivery of regulatory reports for compliance and departmental KPIs.
      • Ensure timely delivery of ad-hoc and regular reports.

    3. Data Compliance:

      • Ensure high data quality of regulatory information.
      • Identify and address data errors and inconsistencies.
      • Manage compliance reports for business stakeholders.

    4. User Training and Support:

      • Deliver effective system user training and promote compliant use of RIM applications.
      • Maintain up-to-date process documentation and training materials.
      • Provide system administration, including user access management.
      • Offer day-to-day support to users and communicate the importance of registration tracking.

    Other Activities:

    • Support other activities related to the Systems team as needed.

    Previous Experience Required:

    • Bachelor’s degree or equivalent experience.
    • Minimum 2 years’ experience in regulatory operations or similar roles.
    • Experience in pharmaceutical organizations, particularly in Regulatory Affairs.
    • Understanding of global regulatory affairs processes.
    • Familiarity with non-prescription healthcare products, including OTC medicines, cosmetics, and devices.
    • Knowledge of EMA EudraVigilance, EVMPD requirements, and Regulatory Information Management.
    • Familiarity with database applications, reporting concepts, and project/business analysis.
    • Proficiency in standard IT applications, especially advanced use of Microsoft Excel.
    • Knowledge of Insight Manager application, cloud-based applications, and systems validation methodologies.
    • Strong organizational, coordination, and editorial skills.

    Diversity, Equity, and Inclusion: Haleon fosters an inclusive environment that celebrates diversity, promotes equitable outcomes, and encourages fair treatment for all. The company values different perspectives, respects individuals, and supports community engagement. Haleon offers an agile working culture and encourages flexibility. Applicants are encouraged to discuss flexible work arrangements with the hiring team.

    Equal Opportunity Employer Statement: Haleon is an Equal Opportunity Employer committed to diversity and inclusion. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, veteran status, or any other protected class under federal, state, or local laws.

    Note:
    For US Licensed Healthcare Professionals, Haleon may be required to report expenses incurred during the interview process to ensure compliance with federal and state transparency requirements. Any personal information provided during the application process will be treated confidentially.

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