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Operations and Compliance Manager
4 months ago
Global Regulatory and Operations Senior Director page is loaded Global Regulatory and Operations Senior Director
Apply locations GB Cambridge time type Full time posted on Posted 30+ Days Ago job requisition id JR1216
Cambridge (Hybrid working - On average two or three times a month in the office)
Permanent
We challenge ourselves constantly to deliver more for patients, healthcare professionals, our partners, and our employees.
The Global Regulatory & Operations Senior Director is responsible for overseeing Regulatory Affairs (RA) Operations, including Global regulatory efforts, Regulatory systems management, vendor coordination, process optimization, and data analytics. They ensure Mundipharma team members deliver 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 capitalise 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 communication skills and ability to engage with Senior Leaders within the organisation effectively.
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 to ensure incorporation of industry best practice in Mundipharma’s approach to RA data, systems management and Operations.
flexible benefits package
Diversity and inclusion
Building an inclusive environment where people can thrive, grow and achieve their full potential is a priority. 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.
Permanent About Us
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 and debilitating disease areas. For more information about Mundipharma's guiding principles and commitment to diversity and inclusion visit:
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