GSK - Senior Regulatory Specialist - CMC Renewals (5-10 yrs)
- 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.
Our goal is to be one of the world's most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing.
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