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Senior Regulatory Affairs Manager Hybrid

3 months ago

Cambridge, Cambridgeshire, United Kingdom Mundipharma Full time
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.


Role and responsibilities 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 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.

What we offer in return flexible benefits package

Diversity and inclusion

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Permanent