Talent.com
This job offer is not available in your country.
[Immediate Start] Regulatory Affairs Associate I

[Immediate Start] Regulatory Affairs Associate I

Teva PharmaceuticalsIndia
7 hours ago
Job description

Role : Regulatory Affairs Associate I (Regulatory Operation- Regulatory Data Analytics)

Primary purpose of the role :

The role of GRO Regulatory Data Analytics is to :

  • Manage Teva's data in accordance with requirements for xEVPMD in order to maintain Teva's Article 57 compliance
  • Provide a Central Data Service for the creation and maintenance of GRA product registration data in line with the global needs of Teva Global Regulatory Affairs.
  • Provide SME services for data management in current and future regulatory data systems

The primary purpose of this position is to execute the operations and services applicable to the GRO Regulatory Data Analytics role in line with business goals and objectives.

Main Duties & responsibilities :

  • Responsible for executing GRO Regulatory Data Analytics operations in line with Work Instructions and SOPs. Primarily will be Regulatory Data Analytics Service related to product registration data management (includes the procurement of data from source regulatory documentation which requires a thorough understanding of the structure and contents of a regulatory dossier, and a thorough understanding of the data structures applicable to registration data and the related system workflows).
  • Operationally hands-on in terms of carrying out data management activities as an individual contributor. This will require a thorough understanding of the structure and contents of a regulatory dossier (i.e. will be fluent in navigating and understanding the contents of a dossier). Registration data management will require a thorough understanding of the registration data structures, workflows, and applicable work instructions etc.
  • Perform Quality Control (QC) and data integrity checking, as part of the Regulatory Data Analytics operation, to confirm the accuracy and completeness of the Teva Global Registration database.
  • Represent GRO Regulatory Data Analytics across the wider Global Regulatory Affairs community. Must be proficient at building effective working relationships with all stakeholder and customer groups.
  • Responsible for providing effective business project contributions for projects focused on improving regulatory data quality, the provisioning of regulatory data for internal re-use via system integration, or the implementation of any business or technology change that impacts regulatory data or the regulatory technology landscape.
  • Qualification & Experience :

  • B Pharm / M Pharm only
  • 1-3 years (Preferred relevant experience in regulatory operations / affairs only)
  • Experience of the pharmaceutical industry with direct experience in Regulatory Affairs, possessing a solid understanding of the pharmaceutical regulatory affairs process.
  • Experience of managing regulatory product registration data, ideally within a regulatory information management environment.
  • Best regards

    Ankita

    Create a job alert for this search

    Regulatory Associate • India

    Related jobs
    • Promoted
    3 Days Left : Regulatory Affairs Associate I

    3 Days Left : Regulatory Affairs Associate I

    Teva PharmaceuticalsIndia
    Role : Regulatory Affairs Associate I (Regulatory Operation- Regulatory Data Analytics).The role of GRO Regulatory Data Analytics is to : . Manage Teva’s data in accordance with requirements for xEVPMD...Show moreLast updated: 3 days ago
    • Promoted
    Associate Director - Advanced Analytics

    Associate Director - Advanced Analytics

    KMK Consulting Inc.Nagpur, IN
    KMK is a global data analytics and technology consulting company empowering leaders across the Life Sciences industries to make better data-driven decisions. Our data analytics and software platform...Show moreLast updated: 30+ days ago
    • Promoted
    • New!
    [Urgent Search] Regulatory Affairs Associate I

    [Urgent Search] Regulatory Affairs Associate I

    Teva PharmaceuticalsIndia
    Role : Regulatory Affairs Associate I (Regulatory Operation- Regulatory Data Analytics).The role of GRO Regulatory Data Analytics is to : . Manage Teva's data in accordance with requirements for xEVPMD...Show moreLast updated: 3 hours ago
    • Promoted
    • New!
    Associate- Regulatory Affairs- India Market

    Associate- Regulatory Affairs- India Market

    DDReg PharmaIndia
    DDReg is seeking a qualified Regulatory Affairs Specialist to join our team, responsible for ensuring compliance with regulatory requirements for India for a portfolio comprising of New Drugs, Gene...Show moreLast updated: 3 hours ago
    • Promoted
    Regulatory Affairs Associate I

    Regulatory Affairs Associate I

    Teva PharmaceuticalsIndia
    Regulatory Affairs Associate I (Regulatory Operation- Regulatory Data Analytics).The role of GRO Regulatory Data Analytics is to : . Manage Teva’s data in accordance with requirements for xEVPMD in or...Show moreLast updated: 4 days ago
    • Promoted
    Regulatory Affairs Associate II

    Regulatory Affairs Associate II

    Teva PharmaceuticalsIndia
    Role : Regulatory Affairs Associate II.Work location : Mumbai & Bangalore.Summary : The Associate II, Complex Gx, Regulatory Affairs is responsible for the preparation and submission of high-quality r...Show moreLast updated: 30+ days ago
    • Promoted
    • New!
    [Apply Now] Regulatory Affairs Associate I

    [Apply Now] Regulatory Affairs Associate I

    Teva PharmaceuticalsIndia
    Role : Regulatory Affairs Associate I (Regulatory Operation- Regulatory Data Analytics).The role of GRO Regulatory Data Analytics is to : . Manage Teva's data in accordance with requirements for xEVPMD...Show moreLast updated: 3 hours ago
    • Promoted
    Scientific Program Associate – Oncology Meeting Innovations (OMI)

    Scientific Program Associate – Oncology Meeting Innovations (OMI)

    DAVA OncologyNagpur, IN
    Oncology Meeting Innovations (OMI).This role involves supporting the.Candidates will contribute to research, content development, and program support activities that drive meaningful collaboration ...Show moreLast updated: 2 days ago
    • Promoted
    ▷ [Only 24h Left] Regulatory Affairs Associate

    ▷ [Only 24h Left] Regulatory Affairs Associate

    PeoplefyIndia
    I am on lookout for Regulatory Affairs Associate for US based, diversified pharmaceutical company in Navi Mumbai.Please refer below JD and share your profile on. Experienced in preparing, review and...Show moreLast updated: 26 days ago
    • Promoted
    Senior Associate, Pharma Commercial Operations

    Senior Associate, Pharma Commercial Operations

    KMK Consulting Inc.Nagpur, IN
    KMK is a global data analytics and technology consulting company empowering leaders across the Life Sciences industries to make better data-driven decisions. Our data analytics and software platform...Show moreLast updated: 30+ days ago
    • Promoted
    Senior Associate US Tax

    Senior Associate US Tax

    MYCPE ONENagpur, IN
    Tax Associate, you will assist in the preparation and filing of federal, state, and local tax returns for corporations, partnerships, and individuals. You’ll gain exposure to a variety of clients an...Show moreLast updated: 1 day ago
    • Promoted
    Regulatory Compliance Specialist -2+

    Regulatory Compliance Specialist -2+

    Jupiter AI LabsNagpur, IN
    Regulatory & Compliance Specialist.India and international destination countries.This role is ideal for professionals experienced in handling regulatory filings, certifications, and export-related ...Show moreLast updated: 19 days ago
    • Promoted
    • New!
    [15h Left] Regulatory Affairs Associate I

    [15h Left] Regulatory Affairs Associate I

    Teva PharmaceuticalsIndia
    Role : Regulatory Affairs Associate I (Regulatory Operation- Regulatory Data Analytics).The role of GRO Regulatory Data Analytics is to : . Manage Teva's data in accordance with requirements for xEVPMD...Show moreLast updated: 19 hours ago
    • Promoted
    Associate Director - Data Sciences

    Associate Director - Data Sciences

    Live ConnectionsNagpur, IN
    Role - Associate Director - Data Sciences.Budget - Up to 50 LPA including 15% Variables.Required Notice Period - Immediate to 30 days only. Hands-on experience in LLM & Fine Tuning.Data Analysis and...Show moreLast updated: 4 days ago
    • Promoted
    Senior Associate – Accelerated Revenue

    Senior Associate – Accelerated Revenue

    ProfessaNagpur, IN
    Professa is looking for a driven Senior .Accelerated Revenue practice and support the growth of our People & Organization consulting work. This is a high-impact role where you will work closely with...Show moreLast updated: 23 days ago
    • Promoted
    • New!
    Immediate Start! Regulatory Affairs Associate I

    Immediate Start! Regulatory Affairs Associate I

    Teva PharmaceuticalsIndia
    Role : Regulatory Affairs Associate I (Regulatory Operation- Regulatory Data Analytics).The role of GRO Regulatory Data Analytics is to : . Manage Teva's data in accordance with requirements for xEVPMD...Show moreLast updated: 3 hours ago
    • Promoted
    Regulatory Affairs Associate

    Regulatory Affairs Associate

    PeoplefyIndia
    I am on lookout for Regulatory Affairs Associate for US based, diversified pharmaceutical company in Navi Mumbai.Please refer below JD and share your profile on pallavi. Experienced in preparing, re...Show moreLast updated: 30+ days ago
    • Promoted
    Regulatory Affairs Excellence Specialist [Apply in 3 Minutes]

    Regulatory Affairs Excellence Specialist [Apply in 3 Minutes]

    PhilipsIndia
    Implements global regulatory strategies and roadmaps by leveraging a comprehensive understanding of the competitive market landscape and product marketing strategy to ensure alignment with organiza...Show moreLast updated: 10 days ago
    • Promoted
    Senior Tax Associate

    Senior Tax Associate

    ElevateNagpur, IN
    Elevate LLC is a national platform built to partner with growth-focused accounting, tax and advisory firms.Our mission is to empower entrepreneurial firms and their leaders by providing the capital...Show moreLast updated: 24 days ago
    • Promoted
    Research Associate / Consultant

    Research Associate / Consultant

    ShhyfftNagpur, IN
    We are looking for an Associate / Consultant to join our Executive Search Practice to help our business grow by identifying and recruiting top talent for executive level positions for our clients.Th...Show moreLast updated: 12 days ago