Systems and Regulatory Affairs Lead
2 weeks ago
Mundipharma is committed to building an inclusive environment where people can thrive, grow and achieve their full potential.
Job DescriptionThis role is a key part of our Regulatory Affairs function, responsible for the strategy and management of all systems and data within the function.
The successful candidate will have experience in regulatory operations, data, and system management, as well as excellent understanding of Regulatory processes, dependencies and risks.
Responsibilities- Develop and implement a comprehensive strategy for regulatory systems, ensuring they meet the needs of the function and wider organisation.
- Oversight of the RIM system, including routine maintenance and system validation, in collaboration with the Mundipharma IT team.
- Lead the external regulatory systems support team, ensuring their delivery meets expectations.
- Evaluate new technologies for future enhancements and improvements, and lead implementation plans.
- Evaluate changes in regulatory guidance and develop strategies to address impact on senior leaders.
- Implement corresponding regulatory guideline impact changes.
- Provide updates to the RIM system or processes required by the business.
- Possess knowledge of budget requirements for RIMS system.
- Oversight of the external data squad team.
- Manage submission management and publishing teams.
- Oversight of the external submission management team and external publishing team.
- Regulatory Data ownership and reporting to the organization.
- Lead data and process analysis to identify areas for increased efficiency and automation of processes.
- Analyse and interpret Regulatory Affairs data, creating dashboards, graphs and visualisations.
- Maintain data in Mundipharma RIM and external systems (SPOR), and associated processes.
- Review vendor metrics and manage delivery with the regulatory team and vendor management team.
- Proven experience in regulatory operations, data, and system management.
- Excellent understanding of Regulatory processes, dependencies and risks.
- Detail oriented.
- Highly organised.
- Self-motivated, driven with a positive attitude.
- Flexible Benefits Allowance.
- Opportunities for learning & development.
- Collaborative, inclusive work environment.
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