Talent.com
Regulatory Affairs Associate I

Regulatory Affairs Associate I

Teva Pharmaceuticalsrajkot, gujarat, 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 • rajkot, gujarat, in

    Related jobs
    • Promoted
    Assistant Manager

    Assistant Manager

    Gujju ExportMorbi, Gujarat, India
    Manage Amazon Seller Central operations.Create and optimize product listings.Monitor account health metrics and ensure compliance. Coordinate with internal teams for pricing, stock, and order manage...Show moreLast updated: 30+ days ago
    • Promoted
    ECommerce Account Coordinator

    ECommerce Account Coordinator

    Gujju ExportMorbi, Republic Of India, IN
    Manage Amazon Seller Central operations.Create and optimize product listings.Monitor account health metrics and ensure compliance. Coordinate with internal teams for pricing, stock, and order manage...Show moreLast updated: 30+ days ago
    • Promoted
    Senior Associate, Pharma Commercial Operations

    Senior Associate, Pharma Commercial Operations

    KMK Consulting Inc.Rajkot, 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!
    Associate

    Associate

    Versetti Family Officerajkot, 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: 14 hours ago
    • Promoted
    Sr. Associate - Risk Advisory

    Sr. Associate - Risk Advisory

    Cherry BekaertRājkot, Republic Of India, 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
    ▷ 15h Left! Senior Associate-Indirect Tax

    ▷ 15h Left! Senior Associate-Indirect Tax

    BDO IndiaRajkot, Gujarat, India
    We assist businesses in Indirect Tax advisory, compliances, transaction structuring, health check and refund related assignments We also assist in review and optimization of input tax credit, recon...Show moreLast updated: 6 days ago
    • Promoted
    Assistant eCommerce Manager

    Assistant eCommerce Manager

    Gujju ExportMorbi, Republic Of India, IN
    Manage Amazon Seller Central operations.Create and optimize product listings.Monitor account health metrics and ensure compliance. Coordinate with internal teams for pricing, stock, and order manage...Show moreLast updated: 30+ days ago
    • Promoted
    Technical Staff Associate - Production

    Technical Staff Associate - Production

    ConfidentialWankaner, India
    Operating powder mixing and grinding systems in accordance with production orders.Unloading and loading silo goods.Unloading and loading palletized goods onto trucks. Loading machines with raw mater...Show moreLast updated: 4 days ago
    • Promoted
    Consultant Cardiovascular Thoracic Surgery

    Consultant Cardiovascular Thoracic Surgery

    ConfidentialMorvi
    Surgical Proficiency : Mastery in performing a wide range of complex cardiothoracic surgeries, including coronary artery bypass grafting (CABG), valve replacements, and lung resections, with experti...Show moreLast updated: 30+ days ago
    • Promoted
    Export Executive Document

    Export Executive Document

    ConfidentialMorbi, India
    We at Lavit Tile LLP, alongside our group of companies, pride ourselves on manufacturing and exporting polished glazed vitrified tiles for the last 26 years. We respond to the latest trends and new ...Show moreLast updated: 4 days ago
    • Promoted
    Associate - Revenue Operations

    Associate - Revenue Operations

    EmeritusRajkot, 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
    Sr. Associate - Risk Advisory (HITRUST)

    Sr. Associate - Risk Advisory (HITRUST)

    Cherry Bekaertrajkot, gujarat, 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
    Senior Associate Director - Public Relations

    Senior Associate Director - Public Relations

    EmeritusRajkot, 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
    Principle Associate

    Principle Associate

    LawSikhorajkot, gujarat, 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: 19 days ago
    • Promoted
    Deputy Manager - QPC, WRW

    Deputy Manager - QPC, WRW

    ConfidentialWankaner, India
    Developing a safe working environment.Safety of people should be the top-most priority and should provide training to workmen to sustain our EHS performance. Daily testing of incoming RM and documen...Show moreLast updated: 2 days ago
    • Promoted
    Senior Associate - Audit

    Senior Associate - Audit

    Grant Thornton INDUSrajkot, gujarat, 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
    Lab Assistant - QPC

    Lab Assistant - QPC

    ConfidentialWankaner, India
    Following, respecting & establishing all EHS guidelines, protocols etc.Ensuring quality & process control during working as per QC guidelines. Overall, in charge to ensure of dispatch of correct pro...Show moreLast updated: 4 days ago
    • Promoted
    Technical Staff Associate

    Technical Staff Associate

    ConfidentialWankaner, India
    Maintenance Technician (Fitter).Calderys is a leading global solution provider for industries operating in high temperature conditions. The Group specializes in thermal protection for industrial equ...Show moreLast updated: 2 days ago