Regulatory Data Governance Lead.

4 weeks ago


Brimscombe Gloucestershire, United Kingdom Mundipharma Full time
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.

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.

Additional Job Description:

Primary Location:
GB Cambridge
Job Posting Date:
2024-10-16
Job Type:
Permanent
  • Data Governance Lead

    2 weeks ago


    Brimscombe, Gloucestershire, United Kingdom Mundipharma Full time

    About the RoleWe are seeking a talented Data Governance Lead - Regulatory Compliance to join our team at Mundipharma. In this role, you will be responsible for the strategy and management of all systems and data within the regulatory affairs function.You will oversee the regulatory information management system (RIM) and external regulatory systems support...


  • Brimscombe, United Kingdom Mundipharma Full time

    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...

  • Data Governance Lead

    4 weeks ago


    Brimscombe, Gloucestershire, United Kingdom Mundipharma Full time

    Job Title: Regulatory Affairs & Systems Data Manager 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...


  • Brimscombe, Gloucestershire, United Kingdom Mundipharma Full time

    About the RoleWe are seeking an experienced Data Governance Specialist to join our team. In this role, you will be responsible for overseeing all systems and data within the regulatory affairs function.The ideal candidate will have a proven track record in regulatory operations, data, and system management. They will also possess excellent understanding of...


  • Alvington, Gloucestershire, United Kingdom Mundipharma Full time

    Data Governance and ComplianceMundipharma is looking for an experienced Regulatory Data Governance Lead to oversee the development and implementation of our regulatory systems and data governance policies.Responsibilities:Strategic Planning: Develop a comprehensive strategy for regulatory systems to ensure compliance and efficiency.RIM Oversight: Manage the...


  • Brimscombe, Gloucestershire, United Kingdom Mundipharma Full time

    Job OverviewMundipharma is seeking a highly skilled Regulatory Affairs Systems Manager to join our team. This role will be accountable for the strategy and management of all systems and data within the regulatory affairs function.The successful candidate will have proven experience in regulatory operations, data, and system management. They will be...

  • Data Governance Lead

    4 weeks ago


    Woolaston, Gloucestershire, United Kingdom Mundipharma Full time

    Job Title: Regulatory Affairs & Systems Data Manager 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...

  • Scheme Governance

    7 months ago


    Gloucestershire, United Kingdom BranWell Ford Full time

    Title: Scheme Governance **Job Type**: Perm Specialism: In-House Workstyle: Fully remote County/Region: Gloucestershire Salary/rate: Negotiable Job ref: HB18408 We are seeking a highly skilled and knowledgeable Pensions Technical & Governance Specialist to join this in house pensions team in a remote capacity. As a Pensions Technical & Governance...


  • Brimscombe, Gloucestershire, United Kingdom Mundipharma Full time

    We are seeking an experienced Regulatory Systems Strategist to join our team at Mundipharma. As a key member of our regulatory affairs function, you will play a critical role in developing and implementing strategies for regulatory systems ensuring they are fit for purpose for the function and wider organisation.Main Responsibilities:Oversight of the RIM...

  • Compliance Lead

    3 weeks ago


    Alvington, Gloucestershire, United Kingdom Mundipharma Full time

    Regulatory Systems Manager Job DescriptionWe are seeking an experienced Regulatory Data Governance Lead to manage and develop our regulatory systems and data governance policies.Main Responsibilities:Regulatory Systems Strategy: Develop and implement a comprehensive strategy for regulatory systems to ensure compliance and efficiency.RIM Management: Manage...


  • Alvington, Gloucestershire, United Kingdom Mundipharma Full time

    Job DescriptionThe Regulatory Affairs and Systems Data Manager will be accountable for the strategy and management of all systems and data within the regulatory affairs function. This includes overseeing the regulatory information management system (RIM) and ensuring its routine maintenance and validation are performed with the Mundipharma IT team.

  • Data Analyst

    4 days ago


    Gloucestershire, United Kingdom Pontoon Full time

    Job title: Business Intelligence - BI Reporting Analyst Contract length: 6 months (extensions likely) Location: Barnwood, Gloucester Job Purpose Participate in the development, implementation, and delivery of accurate MI reports to provide insight and support decision making at an operational and executive level. Assist in the support of the Regulatory...

  • Regulatory Scientist

    2 weeks ago


    Gloucestershire, United Kingdom Hobson Prior Full time

    Hobson Prior is seeking a Clinical Scientist to provide scientific and clinical guidance for programs aimed at addressing unmet medical needs. The successful candidate will play a crucial role in advancing clinical studies and ensuring high-quality data analysis and communication. Review and validate clinical data. Work with biostatistics to analyse data...

  • QA Lead Role

    4 days ago


    Brimscombe, Gloucestershire, United Kingdom Mundipharma Full time

    Job Title: QA Lead RoleAs a QA Lead at Mundipharma in Cambridge, you will play a key role in ensuring the highest standards of quality in our manufacturing operations. This challenging role requires a strong background in QA and a deep understanding of GMP regulations.Responsibilities:Developing and implementing QA policies and procedures.Providing expert...


  • Tewkesbury, Gloucestershire, United Kingdom Bromford Full time

    About the RoleBromford is looking for a Regulatory Compliance Specialist Lead to join our team. This is a crucial role that requires someone with expertise in regulatory compliance and a passion for ensuring our operations meet the highest standards.The successful candidate will have extensive knowledge of compliance-related functions, including gas, oil,...


  • Gloucester, Gloucestershire, United Kingdom Hawk 3 Talent Solutions Full time

    Regulatory Affairs Manager Location: Gloucester Employment Type: Permanent, Full-time (Monday - Friday, Hybrid Options Available) Salary: Competitive, DOE Overview Hawk3 Talent Solutions is seeking a Regulatory Affairs Manager to join a manufacturing organization located in Gloucester. The successful candidate will be responsible for ensuring business...

  • Data Warehouse Leader

    3 weeks ago


    Gloucestershire, United Kingdom RE People Full time

    We are seeking an experienced Data Warehouse Leader to lead our data warehouse operations and team, which includes roles such as BI Analysts, Data Engineers, and Power BI Gateway specialists. This position has been re-established to support a team restructure and address current operational needs due to a recent managerial resignation.About the RoleThis...


  • Gloucestershire, United Kingdom Venn Group Full time

    Venn Group are currently working with an NHS organisation in the South West , who are seeking an Associate Director of Business Operations and Governance to support the Managing Director in ensuring the organisation delivers its strategic, contractual and operational ambitions as outlined in the strategy and business plan. Main duties of the job: Work...


  • Gloucestershire, United Kingdom Venn Group Full time

    Job Description Venn Group are currently working with an NHS organisation in the South West , who are seeking an Associate Director of Business Operations and Governance to support the Managing Director in ensuring the organisation delivers its strategic, contractual and operational ambitions as outlined in the strategy and business plan. Main duties of...


  • gloucestershire, United Kingdom Venn Group Full time

    Job Description Venn Group are currently working with an NHS organisation in the South West , who are seeking an Associate Director of Business Operations and Governance to support the Managing Director in ensuring the organisation delivers its strategic, contractual and operational ambitions as outlined in the strategy and business plan. Main duties of...