Regulatory Specialist, Variations – Senior @ GSK

Minimum 6 yrs of experience in CMC variation in all the markets

With minimal input from manager,executes agreed dossier strategy

                             manages multiple project assignments (e.g., Variations <CMC & Therapeutic>, Product Expansion dossiers, Renewals, MSRs <CMC&non-CMC>) 

simultaneously; dossiers will range in complexity

                             completes data assessment to ensure dossier is fit for purpose.

                             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.

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