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    Regulatory Associate Manager - Bengaluru, India - GSK

    GSK
    GSK Bengaluru, India

    1 week ago

    GSK background
    OTHER
    Description
    Nome della sede: Bengaluru Luxor North Tower
    Data di apertura: Apr

    Job Purpose :

    • Responsible for timely delivery of regulatory activities of multiple Rx and/or Vx projects across dosage forms.
    • Represents CD on Regulatory Networks and Matrix Teams providing guidance to Pharma Supply Chain (PSC), Commercial, Quality Assurance, 3rd Party Contract Manufacturing Organizations and Office of the Chief Medical Officer (OCMO) to produce appropriate components for global regulatory dossiers.
    • Will serve as a mentor/trainer for new team members.

    May act as a Subject Matter Expert for specific areas for consultation within the team/ department as well as externally outside the department.

    Key Responsibilities :

    • Independently and confidently executes agreed dossier strategy.
    • Independently manages multiple Rx and/or Vx project assignments simultaneously; assignments will range in complexity, but more complex work is expected.
    • Independently completes data assessment to ensure dossier is fit for purpose.
    • Identifies risks associated with submission data and information packages.
    • Escalates issues with line manager that have business impact.
    • May act as reviewer/approver for dossiers prepared by peers and identifies improvement opportunities for Regulatory processes, policies and systems.
    • Understands regulations, guidelines, procedures and policies relating to registration and manufacturing of pharmaceutical products, to expedite submission, review and approval of global applications. May provide consultation and solutions being the subject matter expert in specific areas of expertise. Acts as mentor/trainer for new staff.
    • Understands internal/external Regulatory environment.
    • Actively builds an organisational network (PSC, LOC, PO and other relevant stakeholders), promotes and is engaged in knowledge and experience sharing.
    • Communicates across GSK, as necessary regarding project and policy issues ensuring optimum position for GSK.

    Job-Related Experience

    • Minimum 6-10 years of experience
    • Broad understanding of the pharmaceutical industry, drug development environment, and R&D processes and objectives.
    • Global/ EMAP Regulatory submission experience - Knowledge of regulatory agency guidelines
    • Excellent organisational skills, attention to detail and commitment to deliver high quality output, even under pressures sometimes demanded by regulatory deadlines
    • Excellent written and verbal communication skills and ability to present information in a clear and concise manner
    • Ability to interpret and advise on guidelines and requirements on a global basis, reflecting recent GSK experience
    • Ability to build effective working relationships and work in a matrix environment effectively
    • Ability to think flexibly in order to meet constantly shifting priorities and timelines.

    Il nostro obiettivo è di essere una delle aziende sanitarie all'avanguardia in termini di innovazione, performance e affidabilità nel mondo. Crediamo che ognuno di noi contribuisca portando qualcosa di unico in GSK e quando uniamo le nostre conoscenze, esperienze e stili, il risultato è fantastico. Unisciti alla nostra avventura in GSK, dove troverai l'ispirazione per lavorare al meglio per i nostri pazienti e consumatori. Un luogo dove puoi essere te stesso, sentirti bene e continuare a crescere.

    Avviso importante per le imprese/agenzie per l'occupazione

    GSK non accetta referenze da parte di aziende e/o agenzie di collocamento in relazione alle offerte di lavoro pubblicate su questo sito. Tutte le aziende/agenzie di collocamento sono tenute a contattare l'ufficio commerciale e il reparto generale/risorse umane di GSK per ottenere un'autorizzazione scritta prima di segnalare eventuali candidati a GSK. L'ottenimento della previa autorizzazione scritta è una condizione sospensiva rispetto a qualsiasi accordo (verbale o scritto) tra l'azienda/agenzia di collocamento e GSK. In assenza di tale autorizzazione scritta ottenuta, qualsiasi azione intrapresa dall'azienda/agenzia di collocamento verrà considerata eseguita senza il consenso o l'accordo contrattuale di GSK. GSK non sarà quindi responsabile per eventuali commissioni derivanti da tali azioni o commissioni derivanti da eventuali segnalazioni da parte di aziende/agenzie di lavoro in relazione alle offerte di lavoro pubblicate su questo sito.

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