Join as Regulatory Specialist at GSK Pharma

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.

Post : Regulatory Specialist I RIMS

Job Description
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
• Coordinate data collection and reporting process for compliance with timelines for delivery of labelling updates with partners at global, regional, and local levels
• Manage data collection, report dissemination, and follow-up for flagged events within an agreed schedule
• Support the building of a tool and process for setting up baseline data, resource tracking, and forecasting
• Work with Global Labelling teams to improve visibility and access to performance data
• Assist the management team with reports to address performance queries (related to source data) and work with functional group to identify root causes of deviations, or ingredients of success

• Support the system administration of the labelling systems, including training of global and local users, in accordance with GSK policies and procedures
• Work closely with IT Business System Owners to coordinate solutions delivery and support, such as User Acceptance Testing
• Support development and maintenance of labelling websites, Team sites, and other communication channels
• Participate in other projects and activities that support other labelling functions, such as contributing to the implementation of changes to processes within Global Regulatory Affairs (GRA)
• Escalate risks and variances from plan or target when appropriate

Candidate Profile
• Bachelor’s degree
• Experience with Labelling systems, standard operating procedures, and legislative requirements
• Experience with entry, tracking and registration data management systems
• Regulatory document management experience, including experience with Documentum databases and MS team sites
• Master’s degree
• Excellent verbal and written communications skills
• Ability to work carefully under time constraints and prioritize accordingly
• Adaptable to fast-paced environments with changing circumstances, direction, and strategy
• Exposure to work within a regulated environment, ideally in drug development

Additional Information
Qualification : Bachelor’s degree, Master’s degree
Location : Bengaluru
Req ID : 379477
Industry Type : Pharma / Healthcare/ Clinical research
End Date : 30th September, 2023