Regulatory Affairs Systems Manager
5 days ago
Job Summary
We are seeking an experienced Regulatory Affairs Systems Manager to join our team at Mundipharma.
This role will be responsible for the strategy and management of all systems and data within the regulatory affairs function, ensuring they meet the needs of the function and organisation.
Key Responsibilities:
- Develop an overall strategy for regulatory systems, including routine maintenance and validation, working with the Mundipharma IT team.
- Oversight of the RIM system and external regulatory systems support team, ensuring their delivery and provision of budget requirements.
- Evaluate new technologies for future enhancements and improvements, and lead any plans for implementation, including submission management and publishing teams.
- Analyse and interpret Regulatory Affairs data, creating dashboards, graphs and visualisations, and maintain data in Mundipharma RIM and external systems (SPOR).
- Ensure data is up-to-date and accurate, and processes associated with maintaining the data are efficient and automated.
Requirements:
- Proven experience in regulatory operations, data, and system management, with excellent understanding of Regulatory processes, dependencies and risks.
- Detail oriented and highly organised, with a self-motivated and driven attitude.
- Ability to work collaboratively and inclusively as part of a team, with opportunities for learning and development.
What We Offer:
- A competitive salary range of £65,000 - £80,000 per annum, depending on experience.
- A flexible benefits allowance and collaborative, inclusive work environment.
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