As a Regulatory Affairs Operations Staff, you will work with the Governance, Compliance, and Systems team within Global Labelling to ensure that labelling updates in Online Product Authorisation and Lifecycle (OPAL) are monitored and managed in compliance with GSK procedures.
Responsibilities:
- 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 groups 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.
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
- 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
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
- 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
