Global Regulatory Operations Director

1 month ago


Stroud, Gloucestershire, United Kingdom Mundipharma Full time
Job Title: Operations Manager

Location: Cambridge (Hybrid working - On average two or three times a month in the office)

Job type: Permanent

We strive to deliver exceptional results for our patients, healthcare professionals, partners, and employees by pushing the boundaries of what is possible.

The Global Regulatory & Operations Senior Director is responsible for overseeing Regulatory Affairs (RA) Operations, encompassing:

  • Global regulatory initiatives
  • Regulatory systems management
  • Data analytics

They ensure Mundipharma team members execute Global RA initiatives in designated countries (EU and Canada), manage strategy and procurement activities for RA vendors, oversee vendor performance and budget, and proactively manage RA budget and operations in alignment with industry trends and business needs.

Ensure continuous compliance of Mundipharma RA operations across diverse regulatory landscapes in the EU and Canada.

Drive RA operations to meet business requirements while adhering to budgetary constraints.

Develop and execute a robust RA data management strategy, providing valuable insights to internal and external stakeholders.

Uphold data quality standards and compliance protocols, overseeing stakeholders responsible for data entry and maintenance.

Ensure the integrity and efficacy of RA data analytics and reporting, facilitating informed decision-making on vendor performance, budget allocation, and compliance measures.

Lead the strategic management of all RA systems, from conception to implementation and maintenance, ensuring alignment with business objectives and budgetary guidelines.

Craft and communicate a compelling RA systems strategy to senior management, securing buy-in and support for implementation plans.

Monitor regulatory changes, assessing their impact on operations and devising strategies to mitigate risks and capitalize on opportunities.

Manage the global RA vendor strategy, overseeing vendor performance to ensure alignment with business needs, compliance standards, and budgetary goals.

Extensive work as a regulatory professional essential.

Experience of leading Regulatory Operations.

Excellent knowledge of regulatory systems, regulatory systems direction, and systems guidelines.

Management and leadership of local regulatory delivery.

Ability to assess emerging industry trends and ensure incorporation of industry best practices in Mundipharma's approach to RA data, systems management, and Operations.

Diversity and Inclusion

We prioritize building an inclusive environment where people can thrive, grow, and achieve their full potential.



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