Talent.com
No longer accepting applications
Regulatory Affairs Associate I

Regulatory Affairs Associate I

Teva Pharmaceuticalsamravati, maharashtra, 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 • amravati, maharashtra, in

    Related jobs
    • Promoted
    Legal Associate

    Legal Associate

    Settle LoanAmravati, IN
    Location : Gurgaon (Sec 29, near Iffco Metro Station) and Green Park, Delhi (near Metro Station).Save Money Financial Pvt Ltd (Settleloan. Legal Tech company that provides debt resolution and financi...Show moreLast updated: 30+ days ago
    • Promoted
    Sr. Associate - Risk Advisory (HITRUST)

    Sr. Associate - Risk Advisory (HITRUST)

    Cherry Bekaertamravati, maharashtra, 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
    • New!
    Regulatory Affairs Specialist

    Regulatory Affairs Specialist

    Dr. Reddy's Laboratoriesamravati, 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: 17 hours ago
    • Promoted
    Maritime Regulatory Manager - Based in UK

    Maritime Regulatory Manager - Based in UK

    Comaea ConsultingAmravati, IN
    Our client is a MNC n the maritime industry.To support the growth strategy and its expansion, our client is seeking an experienced. We are hiring on behalf of a leading global shipowner and shipping...Show moreLast updated: 1 day ago
    • Promoted
    RB-LS : Business Development Associate

    RB-LS : Business Development Associate

    ConfidentialMorshi, India
    The Liability Sales department focuses on the liability acquisition, assets and retail forex business for the.The department drives business from branches across India and is responsible for sourci...Show moreLast updated: 5 days ago
    • Promoted
    Regulatory Affairs Associate I

    Regulatory Affairs Associate I

    Teva PharmaceuticalsAmravati, Maharashtra, India
    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 accordan...Show moreLast updated: 22 days ago
    • Promoted
    Associate - Revenue Operations

    Associate - Revenue Operations

    EmeritusAmravati, 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
    Research Associate

    Research Associate

    AiDASHAmrāvati, Republic Of India, 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: 10 days ago
    • Promoted
    Senior Associate, Pharma Commercial Operations

    Senior Associate, Pharma Commercial Operations

    KMK Consulting Inc.Amravati, 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
    Assistant Manager

    Assistant Manager

    Glenmark PharmaceuticalsAmravati, Maharashtra, India
    Position Details : Designation : Assistant Manager – Regulatory Affairs CMC Location : Navi Mumbai Reporting to : Deputy General Manager Job Summary : The Assistant Manager – Regulatory Affairs will be...Show moreLast updated: 1 day ago
    • Promoted
    Principle Associate

    Principle Associate

    LawSikhoamravati, maharashtra, 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
    Manager / Sr. Manager Regulatory Affairs– Emerging Markets

    Manager / Sr. Manager Regulatory Affairs– Emerging Markets

    Umedica Laboratories Private LimitedAmravati, Maharashtra, India
    UMEDICA is a vertically integrated company engaged in the manufacturing and export of a wide range of finished formulations i. Tablets, Capsules, Suspensions, Dry Syrups and SVP, at UMEDICA's manufa...Show moreLast updated: 22 days ago
    • Promoted
    Sr. Associate - Risk Advisory

    Sr. Associate - Risk Advisory

    Cherry BekaertAmrāvati, 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
    AI / LLM Technical Lead

    AI / LLM Technical Lead

    FOLD HEALTH INDIA PRIVATE LIMITEDHaveli, MH, in
    Quick Apply
    Lead architecture, design, and implementation of.LLM-based and agentic AI systems.LangGraph, CrewAI, or Semantic Kernel.RAG pipelines and retrieval systems. Pinecone, FAISS, Weaviate, Vertex AI Matc...Show moreLast updated: 2 days ago
    • Promoted
    Senior Associate Director - Public Relations

    Senior Associate Director - Public Relations

    EmeritusAmravati, 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
    • New!
    Senior Regulatory Affairs Trainer(Medical Devices)

    Senior Regulatory Affairs Trainer(Medical Devices)

    Tek Supportamravati, maharashtra, 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: 15 hours ago
    • Promoted
    • New!
    Associate

    Associate

    Versetti Family Officeamravati, 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: 17 hours ago
    • Promoted
    Manager - Regulatory Affairs & Legal

    Manager - Regulatory Affairs & Legal

    Jio InstituteAmravati, Maharashtra, India
    JOB PURPOSE : The job purpose is to provide expert legal counsel and support, ensuring compliance with laws and regulations, safeguarding intellectual property, and facilitating agreements and coll...Show moreLast updated: 11 days ago