GSK - Regulatory Specialist

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.

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

The information managed is the formal record of GSK regulatory activity (documents and data) and 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.

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

- 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

- Coordinate the indexing and abstracting of all types of FDA submissions and associated correspondence into established regulatory document management system(s). Ensure the ability to retrieve, view and print archival

documents. Work independently with very little mentoring support required from other experts or managers.

- Manage existing document management systems and databases used to track and/or archive submissions to the FDA, correspondence from the FDA and associated internal memos and communications, in both paper and electronic format.

- Manage and lead legal document discovery by assisting with file integrity checks and assuring the provision of copies of documents in compliance with FDA regulations and established policies and procedures.

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

- Bachelor's degree in biological or healthcare science qualification or experience within Regulatory Affairs in the Drug development environment

- 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

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