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 :