Manager Regulatory Affairs

  Regulatory Affairs

Job title: Manager Regulatory Affairs

Company: Abbott

Job description: Core Job Responsibilities: * Life Cycle Management of a global product * Global Labeling Portfolio * Record Keeping * Compliance and Audits * GRA Academy

Core Job Responsibilities: Life Cycle Management of a global product Global Labeling Portfolio Record Keeping Compliance and Audits GRA Academy Life Cycle Management of product: u00A0 (list is for reference and not limited): Dossier Strategy & Compilation: Build Strategy for Initial submissions and variation with the compliance standard and support affiliate to achieve fast approval to meet the company strategy and timelines. Initial Submissions/Geo u2013 expansions Collaborate and cordinate with stakeholders for CTD modules (M2, M4, M5, clinical overviews, Literature References, etc.) to ensure timely delivery of the dossiers. Coordination of RA information to be included in periodic reports u2013 RMP, PSURs, ACOs (for renewals). Support renewals with clinical and pre-clinical documentation (EU and EM) Provide relevant documents for variations to EU & EM affiliates Promotional Material Release: Reviews and approves promotional materials with respect to CCDS and are compliant. globally applicable guidance and Ensures that promotional materials are accurate and compliant to internal codes of conduct, established regulations. Query from health authorities : Liase with respective stakeholders to get support on the deficiency requests to respond to health authority in timely manner. Global Labeling Portfolio : Develops and maintains EPD Company Core Data Sheets (CCDS) based on the available scientific knowledge, labeling guidelines, and requirements within the Abbott EPD Labeling Process.Ensures CCDS information is based on Subject Matter Expert (SME in LST) contribution. Organizes and participates in Labeling Sub-Team (LST) meetings, ensuring appropriate actions are followed through. Working with Product Leads, SMEs and cross functional teams ensures appropriate documentation to support label changes (clinical overviews, Module 5 documents, Literature References, etc.) are available to complete labeling project. Independently completes labeling activities assigned.Assesses and approves change requests for labeling documents.Able to participate and contribute to labeling decisions within cross-functional teams. Supervises compliance of local labeling documents for global products and reconciles deviations with company labeling documents (e.g., CCDS, corresponding patient information). Reviews and evaluates new labeling guidelines/policy (High surveillance countries) and determines implications for company labeling documents/labeling of therapeutic area products. Working with Product Leads and SMEs, develops strategic labeling responses to HA queries, within cross-functional team at appropriate time. Educate/guide stakeholders as and when required on labeling management procedure Record Keeping Maintains accurate files of labeling change history and associated documents, using the available company electronic systems from audit perspective and compliance to Abbott SOPs. Archive/Maintain importants and requiered decisions as per applicable GRA SOPs Compliance and Audits: Prepare for central PV audits and inspections by verifying data from available company electronic systems at regular frequency. Collaborate relevant stakeholders to meet compliance Travel: u00A0 Up to 15% may be required

Expected salary:

Location: Mumbai, Maharashtra

Job date: Fri, 26 Aug 2022 22:21:01 GMT

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