Regulatory Specialist Job at GSK Pharmaceuticals
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 : Consultant - Regulatory Specialist : CMC Variations
1. With minimal input from manager, executes agreed dossier strategy
2. 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
3. With minimal input from manager, completes data assessment to ensure dossier is fit for purpose.
4. With minimal input from manager, identifies risks associated with submission data and information packages.
5. Communicates with line manager to identify issues that have business impact.
6. May have dossier review responsibilities for peers and may identify improvement opportunities for Regulatory processes, policies and systems.
7. 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.
8. Understands internal/external Regulatory environment.
9. Actively builds an organisational network.
10. Communicates across GSK, with minimal input from manager regarding project and policy issues ensuring optimum position for GSK.
11. Excellent organisational skills, attention to detail and commitment to deliver high quality output, even under pressures sometimes demanded by regulatory deadlines
12. Excellent written and verbal communication skills and ability to present information in a clear and concise manner
13. Ability to interpret and advise on guidelines and requirements on a global basis, reflecting recent GSK experience
14. Ability to build effective working relationships and work in a matrix environment effectively Ability to think flexibly in order to meet constantly shifting priorities and timelines.
Experience : 4-6 years
Location : Mumbai
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : CMC Variations
Req ID : 256665
End Date : 30th July, 2020
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