GSK Rx India looking for Regulatory Specialist
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.
- 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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