Regulatory Specialist RIM I

Site Name: Bengaluru Luxor North Tower Posted Date: Feb 8 2023 Is there any greater challenge than getting ahead of disease? We’re combining the power of genetic and genomic insights into what causes disease, with the speed and scale of artificial intelligence and machine learning (AI/ML) to make better predictions about who a treatment might work for, and why. We believe this powerful combination of data and technology holds the key to fundamentally transforming medical discovery for the better, improving R&D success rates and shaping how even the most challenging diseases, like neurological conditions and cancer, can be both prevented and treated. In 2021 we delivered four major product approvals: Cabenuva for HIV, Jemperli for endometrial cancer, Xevudy for COVID-19 and Apretude, our new long-acting medicine for HIV prevention. Job Purpose:- Ensures that GSK portfolio of product regulatory information is maintained to a standard appropriate to support critical regulated processes including Pharmacovigilance and GMP-compliant product supply. This data also supports the efficient operational management of the Regulatory function, worldwide. The role provides operational support to RIMS end-users. Key Responsibilities:- The information (data and documents) managed by Regulatory Information Management is critical to patient safety, regulatory compliance and effective business operations. The post holder is accountable for the quality and accuracy of their own work and for the support of the large number of other users across GSK. The role provides operational support to Regulatory Information Management Systems (RIMS) end-users. Responsibilities of this role are: Supervise and support and monitor quality of the work of junior colleagues Advise, train and support users of the global Regulatory Information Management (RIM) systems and procedures Accurate completion of more complex or non-routine data maintenance tasks to agreed schedule Ensure own work and that of junior colleagues is compliant with data standards and defined procedures Ensure defined quality control procedures are followed and appropriate actions taken following any issues identified during routine quality monitoring activities. Trouble shoot problems when required and propose appropriate solutions Identify areas for improvements/efficiencies in existing processes and contributes to the Regulatory Information Management Systems (RIMS) Change Control Process Maintain knowledge of GSK standards and procedures associated with registration data management and contribute to the definition of new and revised procedures to improve quality and effectiveness Routine/ ad-hoc extraction and transformation of raw data from various Regulatory Information Management Systems (RIMS) for KPI generation in the context of data quality improvement and performance monitoring Knowledge/ Education / Previous Experience Required:- A. Educational Background 1. Minimum Level of Education - India - Bachelor’s degree in biological or healthcare science qualification or experience within Regulatory Affairs in the Drug development environment Area of Specialization - IT, Chemistry, pharmacy or other related science or regulatory affairs. Project Management, Communication 2. Preferred Level of Education - India : Masters degree or higher in biological or healthcare science Area of Specialisation - IT, Chemistry, pharmacy or other related science or regulatory affairs. Project Management, Communication B. Job-Related Experience:- Minimum Level of Job-Related Experience required Minimum 4-5 years of experience in data and/or record management, handling user requests; consistent and accurate completion of a significant number of data management tasks, including a broad range of regulatory procedures 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 organisational skills, attention to detail and commitment to deliver high quality output, even under pressures sometimes demanded by regulatory deadlines Excellent written and verbal communication skills and ability to present information in a clear and concise manner Direct or indirect experience of regulatory processes associated with gaining and maintaining product registrations (for both Investigational and Marketed Products) and Regulatory Information Management Systems Ability to present and actively communicate Regulatory Archives requirements and policies and champion change. C. Other Job-Related Skills/Background :- Excellent attention to detail and commitment to deliver high quality output, even under pressures sometimes demanded by regulatory deadlines. Demonstrated ability to think flexibly in order to meet constantly shifting priorities and timelines. Strong interpersonal skills, service-oriented attitude and ability to interact effectively with all levels of personnel in an interdisciplinary and matrix environment. Excel macro/pivot table skills is a plus Knowledge of records retention procedures and relevant regulations and business practices regarding regulatory document management. Demonstrates the following behaviors: Customer focus Enable and drive change Service orientation, customer-focused Ability to work carefully under time constraints and prioritize accordingly Good team worker Awareness of Regulatory Information Management Systems and their criticality to legislative requirements At GSK we value diversity (Gender, LGBTQ +, PwD etc.) and treat all candidates equally. We aim to create an inclusive workplace where all employees feel engaged, supportive of one another, and know their work makes an important contribution. *LI-GSK GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. 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