Career as Regulatory Specialist MSR Coordination Senior at GSK India
GlaxoSmithKline Pharmaceuticals Ltd. (GSK Rx India) is one of the oldest pharmaceuticals company and employs over 5000+ people. Globally, we are a £ 27.4 billion, leading, research-based healthcare and pharmaceutical company. In India, we are one of the market leaders.
Post : Regulatory Specialist MSR Coordination Senior
Job description
– Minimum 5 years of experience in CMC variation in all the markets
– Minimum 5 years of experience in CMC variation in all the markets
Expertise in CMC Authoring of Variation dossier (focus on Module 3 components authoring)
– Experience in authoring variation of Vaccines (preferable) , we can consider for Pharma also
– CMC Variation experience for – EU and ROW / International markets
– Knowledge on Vaccines
– 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.
– 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.
Additional Information
Location : Bangalore
Qualification : M.Pharm, M.Sc
Req ID : 247865
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Regulatory Affairs, R&D
End Date : 20th April, 2020
Location : Bangalore
Qualification : M.Pharm, M.Sc
Req ID : 247865
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Regulatory Affairs, R&D
End Date : 20th April, 2020