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
- 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.
- 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.
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
See All Other Jobs in our Database