Regulatory Affairs Vacancy At GSK Egypt
Vacancy title:Submission Delivery Specialist,Assembly
Job Description:
Are you looking for a regulatory affairs role that will enhance your documentation knowledge and allow you to help shape systems strategy? If so, this Regulatory Affairs Operations role could be an exciting opportunity to explore.
As a Regulatory Affairs Operations Staff, you will work with the Governance, Compliance, and the Systems team within Global Regulatory Center to ensure right first time submission of updates in Product Authorization and Lifecycle are monitored and managed in compliance with GSK procedures.
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 variations for 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 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.
Participate in other projects and activities that support other Submissions, 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 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
Deadline for receiving applications: 17 August 2023