Global Regulatory and Operations Senior Director

3 weeks ago

Cambridge, United Kingdom Mundipharma Full time
  • Location: Cambridge (Hybrid working - On average two or three times a month in the office)
  • 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 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 .
  • Oversee RA delivery across multiple countries, leveraging both internal expertise and external vendor resources.
  • 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.
  • Proactively evaluate emerging technologies for potential integration into RA operations, driving continuous improvement and efficiency.
  • 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.
What you'll bring
  • BSc degree in life sciences.
  • Extensive work as a regulatory professional essential.
  • Experience of leading Regulatory Operations.
  • In-country or above-country RA experience in EU or Canada.
  • Experience of vendor oversight and outsourcing delivery models.
  • Strong leadership and problem-solving skills.
  • Excellent communication skills and ability to engage with Senior Leaders within the organisation effectively.
  • Effective collaborator and strong customer and stakeholder focus.
  • 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
  • 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

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Additional Job Description:

Primary Location:
GB Cambridge
Job Posting Date:
2024-03-19
Job Type:
Permanent

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