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GlaxoSmithKline Pharmaceuticals

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4.1

based on 1.8k Reviews

Video summary

52 GlaxoSmithKline Pharmaceuticals Jobs

Regulatory Specialist, Labelling Business Performance

GlaxoSmithKline Pharmaceuticals Limited

4.1

based on 1.8k Reviews

2-4 years

₹ 5.5 - 8.84L/yr (AmbitionBox estimate)

Bangalore / Bengaluru

1 vacancy

Regulatory Specialist, Labelling Business Performance

GlaxoSmithKline Pharmaceuticals

posted 1d ago

Job Role Insights

Flexible timing

Key skills for the job

Automation Testing Project Management Clinical Data Management Procurement Life Sciences Analytical Chemistry

+ 4 more

Job Description

Basic Qualification -
Years of experience - 2 - 4 years Must have skills - Regulatory and Labelling. Education - Bachelor s degree in business administration or life sciences field or related field that is appropriate to the function. Location - Bangalore.

Key Responsibilities -

Coordinate data collection for performance & compliance metrics, report dissemination and follow-up for flagged events related to labelling activities within an agreed schedule across global, regional, and local levels
Assist with activities for the development, implementation, maintenance, and use of standards and processes to maximize quality and efficiency of continuous improvements
Provide support with building tools and defining processes for data analytics, modelling, transformation, integration, reporting etc. on business data to improve visibility of key performance indicators (KPIs), resource tracking, compliance monitoring, and forecasting
Confirm accuracy of metrics, compile monthly reports, and escalate of risks and variances when appropriate
Assist with development and maintenance of content for websites, GSK team sites, MS Teams, SharePoint lists, and other communication channels
Work with functional groups to recognize trends, patterns and improvements using data along with identifying root causes of deviations, or ingredients of success
Contribute to automation and simplification initiatives to reduce manual/redundant processes, eliminate risks, and drive continuous improvement
Support labelling systems with training of global and local users in accordance with GSK policies and procedures
Understanding of system testing tools and procedures to work with Tech and Business System Owners on solution delivery and support, such as the participation in user acceptance testing (UAT), migration and training
Support assignments for new system functionalities and data requirements to meet business needs of GSK Labelling and supported business partners
Horizon scan to stay up to date with the latest technology, techniques, and methods available internally and externally

Analytical skills -

Good computer skills and proficient in Excel, Word, Access, Outlook, and PowerPoint
Strong data analytical and problem-solving skills with the ability to synthesize (source, consolidate and mine) data and extensively analyse data, trends and produce reports.
Understanding database modelling and design in combination with utilization of analytical tools (e.g. Power BI, Qlik, Tableau) to communicate appropriate information to target audience Support activities for accuracy, completeness, timeliness, and reconciliation of data between multiple systems and databases.
Ability to quickly assimilate facts and data
Ability to communicate complex matters with simplicity - persuasive with details and facts
Solid problem-solving with ability to challenge assumptions, drive change and improvement
Understanding of the functional activities and drivers of performance in the assigned function
Ability to translate processes, concepts, and strategies into measurable objectives.

Project management & interpersonal skills -

Some project management and facilitation abilities/ experience
Adaptable to fast-paced environments with changing circumstances, direction, and strategy within a diverse organization.
Knowledge of project and programme management concepts and techniques
Ability to plan, coordinate, facilitate and executing projects
Prioritize work requests and oversee project execution to ensure requirements are met, timelines are achieved, and customer needs are addressed
Ability to think flexibly to meet shifting priorities and timelines

Related Experience -

Service orientation, customer-focused
Excellent communications skills.
Fluent and able communicator in English and able to communicate with users for whom English is not their primary language.
Ability to work carefully under time constraints and prioritize accordingly
Good team worker
Awareness of Labelling & Quality systems and their criticality to internal standard operating procedures and legislative requirements
Data mining experience
Direct or indirect experience of regulatory processes associated with management of labelling update information in validated regulatory systems
Exposure to work within a regulated environment, ideally in drug / vaccines development.
Regulatory document management experience
Experience and familiarity of working within databases and MS team sites
Familiarity with entry, tracking and registration data management systems

Mandatory skills -

2-3 years relevant experience (in pharmaceutical industry, life sciences research or regulatory) delivering business operational support to critical business systems in a global environment
Successfully performed within a regulated or quality-critical environment such as pharmaceutical industry research or regulatory)
Consistent and accurate completion of data reporting, analysis, and follow-up tasks
Ability to use adequate tools and systems to collate and report on appropriate performance and compliance measures for the business
High Attention to detail, significant experience with document and database management, excellent organization and time management skills, and a commitment to quality
Excellent written and verbal communication skills and ability to present information in a clear and concise manner
Understanding of the pharmaceutical industry, drug development environment, and regulatory processes