GSK Rx India looking for Regulatory Specialist

GSK Rx India looking for Regulatory Specialist 

Job description

Site Name: India – Karnataka – Bengaluru
Posted Date: Mar 3 2021

  • Responsible for the GRPD regulatory delivery activities (e.g., Variations <CMC & Therapeutic>, Product Expansion dossiers, Renewals, MSRs <CMC&non-CMC>) of assigned projects with minimal input from line manager.
  • Supports Global Regulatory by producing appropriate components for global regulatory dossiers with minimal input from line manager.
  • Has training responsibilities for new staff on established departmental processes.

Job Description:

  • With minimal input from manager, executes agreed dossier strategy
  • With minimal input from manager, manages multiple project assignments (e.g., Variations <CMC & Therapeutic>, Product Expansion dossiers, Renewals, MSRs <CMC&non-CMC>) simultaneously; dossiers will range in complexity
  • With minimal input from manager, completes data assessment to ensure dossier is fit for purpose.
  • With minimal input from manager, identifies risks associated with submission data and information packages.
  • Communicates with line manager to identify issues that have business impact.
  • May have dossier review responsibilities for peers and may identify improvement opportunities for Regulatory processes, policies and systems.
  • Developing an understanding of regulations, guidelines, procedures and policies relating to registration and manufacturing of pharmaceutical products, to expedite submission, review and approval of global regulatory applications.
  • Understands internal/external Regulatory environment.
  • Actively builds an organizational network.
  • Communicates across GSK, with minimal input from manager regarding project and policy issues ensuring optimum position for GSK.

Minimum Requirement :

  • Minimum 5 years of experience
  • Knowledge of worldwide CMC regulatory requirements.

 

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