ARA-P3-12 Job Title: Regulatory Affairs & Systems Data Manager Location: Cambridge (Hybrid/Flexible) Job type: permanent At Mundipharma, we are proud of the work we do to bring innovative treatments to patients.
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.
Role and responsibilities 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 Responsible for providing budget requirements for RIMS system 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 What you'll bring 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.
Excellent communication skills.
What we offer in return Flexible Benefits Allowance opportunities for learning & development collaborative, inclusive work environment Diversity and inclusion Building an inclusive environment where people can thrive, grow and achieve their full potential is a priority.
We believe this isn't just the right thing, but also the smart thing to do, as we focus on making a positive difference for our customers and their patients.
About Mundipharma Mundipharma is a global healthcare company with a presence across Africa, Asia Pacific, Canada, Europe, Latin America, and the Middle East.
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.
Our guiding principles, centered around Integrity and Patients-Centricity, are at the heart of everything we do.
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Additional Job Description: Primary Location: GB Cambridge Job Posting Date: 2024-10-16 Job Type: Permanent