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    Regulatory Associate Manager - Bengaluru, India - GSK

    GSK
    GSK Bengaluru, India

    1 month ago

    GSK background
    OTHER
    Description
    Nom du site: Bengaluru Luxor North Tower
    Data de publication: 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.

    Notre objectif est d'être l'une des entreprises les plus innovantes, les plus performantes et dignes de confiance de l'industrie pharmaceutique. Nous pensons que nous apportons quelque chose d'unique chez GSK et lorsque nous associons nos connaissances, nos expériences et nos styles, l'impact est incroyable. Venez rejoindre notre aventure chez GSK où vous trouverez l'inspiration pour faire au mieux votre travail pour nos patients et pour nos clients. Un endroit où vous pouvez vous recentrer, vous sentir bien et aller de l'avant.

    Avis important à l'attention des sociétés de recrutement/agences pour l'emploi

    GSK n'accepte pas de recommandations provenant de sociétés de recrutement/agences pour l'emploi en ce qui concerne les postes à pourvoir sur ce site. Toutes les sociétés de recrutement/agences pour l'emploi doivent contacter les services des ressources humaines/des achat généraux et commerciaux de GSK pour obtenir une autorisation écrite préalable avant de recommander des candidats à GSK. L'obtention d'une autorisation écrite préalable est une condition préalable à tout accord (oral ou écrit) entre la société de recrutement/l'agence pour l'emploi et GSK. En l'absence d'une autorisation écrite, toute action de la part de la société de recrutement/l'agence pour l'emploi sera jugée comme ayant été effectuée sans le consentement ou l'accord contractuel de GSK. GSK ne pourra par conséquent pas être tenue responsable des frais découlant de ces actions ou des frais découlant de recommandations par des sociétés de recrutement/agences pour l'emploi en ce qui concerne les postes à pourvoir sur ce site.

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