Talent.com
No longer accepting applications
Regulatory Affairs Associate I

Regulatory Affairs Associate I

Teva Pharmaceuticalsraipur, chattisgarh, in
22 days 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

    Associate • raipur, chattisgarh, in

    Related jobs
    • Promoted
    Regulatory Affairs Associate I

    Regulatory Affairs Associate I

    Teva Pharmaceuticalsraipur, India
    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: 15 days ago
    • Promoted
    Senior Associate, Pharma Commercial Operations

    Senior Associate, Pharma Commercial Operations

    KMK Consulting Inc.raipur, chattisgarh, 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!
    Senior Associate, Technical Operations

    Senior Associate, Technical Operations

    Albert Inventraipur, chattisgarh, in
    Albert‘s mission is to Digitalize the World of Chemistry, using data and machine learning to drastically accelerate the invention of new materials. We are looking for individuals to join our strateg...Show moreLast updated: 21 hours ago
    • Promoted
    • New!
    Senior Regulatory Affairs Trainer(Medical Devices)

    Senior Regulatory Affairs Trainer(Medical Devices)

    Tek Supportraipur, chattisgarh, in
    Job Title : Senior Trainer – Regulatory Affairs (Medical Devices).The ideal candidate will have hands-on experience in global regulatory submissions, product registration, quality system compliance,...Show moreLast updated: 17 hours ago
    • Promoted
    Manager EHS

    Manager EHS

    Pipal BizBhilai, Chhattisgarh, India
    Manager - Environmental Health & Safety.Heavy Engineering & Manufacturing.Manager - Environmental Health & Safety.The role demands expertise in IMS, ISO 9001, 14001, 45001 and auditing, along with ...Show moreLast updated: 30+ days ago
    • Promoted
    Senior Associate Director - Public Relations

    Senior Associate Director - Public Relations

    Emeritusraipur, chattisgarh, in
    Emeritus is committed to teaching the skills of the future by making high-quality education accessible and affordable to individuals, companies, and governments around the world.It does this by col...Show moreLast updated: 1 day ago
    • Promoted
    Sr. Associate - Risk Advisory (HITRUST)

    Sr. Associate - Risk Advisory (HITRUST)

    Cherry Bekaertraipur, chattisgarh, in
    Cherry Bekaert is a nationally recognized CPA firm with over 75 years of experience providing assurance, tax, and advisory services to our clients. We are seeking a Senior Associate (HITRUST) to joi...Show moreLast updated: 15 days ago
    • Promoted
    Principle Associate

    Principle Associate

    LawSikhoraipur, chattisgarh, in
    We are seeking an experienced Tax & Finance Professional / Chartered Accountant / CMA to join our finance team.The ideal candidate will be responsible for ensuring end-to-end tax compliances, strengthe...Show moreLast updated: 20 days ago
    • Promoted
    Associate - Revenue Operations

    Associate - Revenue Operations

    Emeritusraipur, chattisgarh, in
    Emeritus has partnered with more than 30 universities to date, including MIT, Columbia, Harvard, Cambridge, INSEAD, Wharton, UC Berkeley, INCAE, IIT, IIM, NUS, and HKUST, launching more than 100 co...Show moreLast updated: 22 days ago
    • Promoted
    Macawber Beekay - Project In charge

    Macawber Beekay - Project In charge

    Macawber Beekay Pvt Ltd.Chhattisgarh, India
    Key Responsibilities include : - Managing project activities from planning, budgeting, execution, to completion, ensuring compliance with technical specifications and ...Show moreLast updated: 30+ days ago
    • Promoted
    • New!
    Associate

    Associate

    Versetti Family Officeraipur, India
    Versetti Family Office, founded by serial entrepreneur Angel Versetti, is dedicated to advancing the boldest longevity ventures with funding, strategic guidance, and operational support.As a Longev...Show moreLast updated: 20 hours ago
    • Promoted
    • New!
    Regulatory Affairs Specialist

    Regulatory Affairs Specialist

    Dr. Reddy's Laboratoriesraipur, India
    We are seeking a detail-oriented Specialist in Regulatory Affairs primarily focusing on Oligonucleotides typically has a role that involves ensuring compliance with regulatory requirements for thes...Show moreLast updated: 20 hours ago
    • Promoted
    PARFI - Principal Associate - Projects & Procurement

    PARFI - Principal Associate - Projects & Procurement

    PANIIT ALUMNI REACH FOR JHARKHAND FOUNDATIONChhattisgarh, India
    Alumni Reach For India Foundation IITB office : PanIIT Alumni Reach For India Foundation (CIN : U93000MH2009NPL196614), MAB 09, Basement, Mathematics Dept, IIT Bombay, Po...Show moreLast updated: 9 days ago
    • Promoted
    Chief Manager - Data Science

    Chief Manager - Data Science

    Xpert ConexionsChhattisgarh
    Job Description Role & Responsibilities - Analyzing large datasets to identify trends, patterns, and insights.Using statistical methods to validate fin...Show moreLast updated: 30+ days ago
    • Promoted
    Associate Lawyer

    Associate Lawyer

    LawSikhoRaipur, Chhattisgarh, India
    Job Description : Faculty for Academic Writing & AI Integration Company Description Skillarbitrage is an initiative of Addictive Learning Technology Pvt Ltd, enabling global remote work opportunitie...Show moreLast updated: 13 days ago
    • Promoted
    Senior Associate - Audit

    Senior Associate - Audit

    Grant Thornton INDUSraipur, chattisgarh, in
    As a Senior Associate, professional will be leading engagement and responsible for performing audit under remote service delivery model by following Grant Thornton Audit approach, methodology and t...Show moreLast updated: 21 days ago
    • Promoted
    • New!
    State Coordinator, Program Operations

    State Coordinator, Program Operations

    Room to Read IndiaChhattisgarh, India, India
    The State Coordinator, Program Operations is responsible for Room to Read’s operations in a geographic area, a state in this case. The State Coordinator is primarily responsible for ensuring governm...Show moreLast updated: 21 hours ago
    • Promoted
    Research Associate

    Research Associate

    AiDASHraipur, chattisgarh, in
    AiDASH is making critical infrastructure industries climate-resilient and sustainable with satellites and AI.Using our full-stack SaaS solutions, customers in electric, gas, water utilities, transp...Show moreLast updated: 11 days ago