POSITION SUMMARY: The Systems Manager is a vital member of the Regulatory Affairs (RA) team, responsible for supporting the Regulatory Systems team by fulfilling Regulatory Affairs system needs. The position requires a deep understanding of Regulatory Affairs and specific regulatory technologies, such as Document Management Systems, Publishing Tools, and Regulatory Information Management Systems. This individual will work under the guidance of the Global Regulatory Systems Senior Manager to assist in the development and maintenance of all regulatory system application activities. They will also collaborate with Information Systems (IS) Business Partners to ensure the day-to-day support of systems, meeting the business needs and focusing on enhancing operational support.
ESSENTIAL FUNCTIONS: The responsibilities of this position include, but are not limited to, the following:
* Serves as an Administrator, providing support for various Regulatory systems and technologies. They will handle issues escalation and resolution related to Global Regulatory business processes.
* Participates in technology projects by gathering and validating requirements, aligning them with business objectives, and contributing to the success of Regulatory Affairs technology objectives.
* Ensures the successful and timely completion of deliverable according to project schedules.
* Identifies and applies systematic quality activities to ensure that projects comply with all processes required to meet Computer System Validation directives.
* Creates, collects, distributes, stores, and updates relevant project documentation for effective communication with all stakeholders.
* Under the guidance and supervision of the Global Regulatory Systems Senior Manager, updates documents for validated systems.
* Partners with business and technology counterparts to elicit, analyse, and document business requirements, translating them into technical specifications.
* Analyses, documents, and tests program development, logic, process flows, and specifications. * Performs functional testing of end-user requirements.
* Maintains up-to-date knowledge of industry guidance and regulations concerning Regulatory technologies and processes.
* Develops and coordinates user training for Regulatory system applications.
* Creates user guides and reference materials for the full life cycle management of documents within the Electronic Document Management System (EDMS) and Regulatory Information Management (RIM) System. * Assists the business in audit and inspection preparedness.
* Serves as a point of contact for data clean-up and content management.
* Develops and implements Policies, Standard Operating Procedures, and Working Instructions for various Regulatory Applications.
* Collaborates with other business functions, including Clinical, Chemistry Manufacturing Controls (CMC), and others, to facilitate cross-functional utilisation of technologies.
* Ensures compliance for Regulatory systems using a System Development Life cycle (SDLC) methodology in a regulated environment, including system validation.
* Monitors and manages Data Governance, Data Compliance, and Data Life cycle for the information maintained in RIM.
* Collaborates with colleagues across the organisation to ensure data integrity in the managed systems.
MINIMUM QUALIFICATIONS:
Education: Bachelor's degree in a science or related field or equivalent specialised degree with relevant experience.
Field of Study: Open, in combination with experience.
Experience: 5+ years of experience in Regulatory Affairs and/or Regulatory Systems.
License/Certifications: Preferred but not required.
Travel: 5%
COMPETENCIES/CONDUCT: In addition to the minimum qualifications, the employee will demonstrate:
* Experience multitasking in a deadline-controlled and highly regulated environment.
* Detail-oriented with a focus on delivering accurate results.
* Ability to work effectively in diverse and matrix team environments to successfully complete system-related projects on schedule.
