Senior Manager/Director Of Regulatory Affairs

4 weeks ago

Berkeley, United Kingdom Mundipharma Full time

Job Title: Regulatory Affairs & Systems Data Manager Cambridge (Hybrid/Flexible) Job type: permanent We challenge ourselves constantly to deliver more for patients, healthcare professionals, our partners, and our employees.
The Manager will be accountable for the strategy and management of all systems and data within the regulatory affairs function.
You will be responsible for the strategy and oversight of the regulatory information management system (RIM) and oversight of the regulatory systems support group and regulatory submission management and publishing teams.
You will also be responsible for regulatory data management and also management of training and SOPs for regulatory.
Overall strategy of the regulatory systems ensuring they are fit for purpose for the function and wider organisation Oversight of the RIM system including management of routine maintenance and system validation working with the Mundipharma IT team Responsible for the external regulatory systems support team and ensuring their delivery.
Responsible for the ongoing strategy of the regulatory information management system including; Evaluate new technologies for future enhancements and improvements and lead any plans for implementation.
Evaluate changes in regulatory guidance and highlight impact and impact strategy management to senior leaders.
Responsible for leading any corresponding regulatory guideline impact implementation.
Responsible for updates to the RIM system or processes required by the business Oversight of the external data squad team Management of submission management and publishing teams Oversight of the external submission management team and external publishing team Regulatory Data ownership and reporting to the organization Responsible for proactively leading data and process analysis to identify areas to increase efficiency and automation of processes Manipulate, analyse and interpret Regulatory Affairs data, creating dashboards, graphs and visualisations.
Prepare reports for internal and external audiences using business analytics reporting tools.
Responsible for Data maintained in Mundipharma RIM and external systems (SPOR) and the processes associated to maintaining the data Responsible for reviewing vendor metrics and managing 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 Flexible Benefits Allowance Diversity and inclusion Building an inclusive environment where people can thrive, grow and achieve their full potential is a priority.
Mundipharma is dedicated to bringing innovative treatments to patients in the areas of Pain Management, Infectious Disease and Consumer Healthcare as well as other severe debilitating disease areas.
Join our talent pool If you're not sure this role is right for you but you're keen to hear about future opportunities at Mundipharma, join our talent community and be the first to hear about new roles.
Permanent

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