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. At GSK, our mission is to improve the quality of life by enabling people to do more, feel better and live longer. This mission drives us to make a real difference to the lives of millions of people with our commitment to effective healthcare solutions.
Post : Consultant - Regulatory Specialist RRDM Level 1
Job description
• Accurate completion of routine data maintenance tasks to agreed schedule
• Ensure own work is compliant with data standards and defined procedures
• Ensure defined quality control procedures are followed
• Capable of performing routine data extraction from RIMS to support KPI generation
• Maintain knowledge of GSK standards and procedures associated with RIMS and contribute to the definition of new and revised procedures to improve quality and effectiveness
• Indexing, abstracting and quality assurance of US/UK submissions and associated correspondence into established regulatory document management system(s).
• Supporting Legal and Business Development project work for document discovery, in-licensing, and out-licensing initiatives.
• Support customer requests, as needed, by conducting specific searches for proprietary regulatory information using on-line databases.
• Working on Special projects as required in response to internal and external customer requests.
• Support for IT related activities
Candidate Profile
• Experience in delivering business operational support (in pharmaceutical industry, life sciences research or regulatory). Have worked on regulatory submission, have fair knowledge on the CAPA and audit reports
• Demonstrated ability to proactively manage workload, timelines and identify priorities. Build relationships with relevant internal functions.
• Proven ability to work on multiple projects simultaneously.
• Excellent written and verbal communication skills and ability to present information in a clear and concise manner
• Ability to think flexibly in order to meet constantly shifting priorities and timelines.
• Has worked successfully with a complex computer system
• Interacts with customers to ensure compliance with regulatory records and data management requirements.
Additional Information
Location : Bangalore R&D
Req ID : 245336
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : R&D
End Date : 10th March, 2020
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