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Regulatory Affairs Manager

Regulatory Affairs Manager

MundipharmaSharpness, ENG, UK
4 days ago
Job type
  • Permanent
Job description

Job Description

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...