Regulatory Affairs Systems and Data Manager

Regulatory Affairs & Systems Data Manager - Location: Cambridge (Hybrid/Flexible), Job type: Permanent

Join us and make a difference when it matters most! 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.

Role and Responsibilities

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. This role is also responsible for managing, developing and enhancing regulatory data management to ensure compliance, and to drive compliance and efficiencies in our regulatory processes using Veeva Vault RIM system. Working in a highly collaborative environment this role will engage with multiple areas of the business.

Strategic oversight of the regulatory information management system

• Responsible for the ongoing strategy of the regulatory information management system
• Oversee the implementation, maintenance and optimization of Veeva RIM
• Identify opportunities to enhance RIM capabilities to streamline regulatory processes
• Collaborate with various stakeholders across the business to integrate RIM across the business
• Liaise with vendor(s) and Mundipharma IT to ensure that Veeva delivers optimally for the business, evaluating Veeva functionality and upgrades and impact on the business and its data
• Monitor changes in regulatory and industry requirements and assess the impact of those on RIM requirements

Regulatory Data ownership and reporting to the organization

• Develop reporting mechanisms to ensure that senior management have oversight of compliance and risks
• Utilize data analytics and reporting tools to track compliance metrics and generate actionable insights to senior management
• Advise on the optimal use of regulatory data and create dashboards, reports etc. for internal and external audiences using business analytics reporting tools
• Conduct audits and assessments to ensure regulatory data compliance
• Responsible for data maintained in external systems such as SPOR and the processes associated to maintaining the data
• Responsible for RA hard copy data management globally

Training and Process Development

• Set up and/or update regulatory affairs SOPs, instructions, and guides for the use of Veeva and for other RIM activities
• Deliver appropriate training for users, both internally and for external vendors

Management of submission management and publishing teams

• Oversight of the external submission management activities
• Evaluate new technologies for future enhancements and improvements and lead any plans for implementation
• Responsible for assessing budget requirements around regulatory data management requirements

What you'll bring

• Proven experience working in the pharmaceutical industry in a regulatory/regulatory operations function
• Proficiency in using Veeva Vault RIM and experience in driving its implementation and enhancement
• Understanding global regulatory requirements and compliance standards
• Understanding the importance of regulatory data management
• Able to act independently and proactively problem solve
• Excellent written and verbal communication skills
• Ability to work in a fast-paced, dynamic environment

What we offer in return

• Flexible benefits package
• Opportunities for learning & development through our varied programme
• 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. We will create a workplace environment where everyone can, every day, bring their authentic selves and is treated with dignity and respect.