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Operations Senior Director
3 months ago
Cambridge (Hybrid working - Two or three days a month in the office)
Job Type:Permanent
At Mundipharma, we take pride in our work of delivering innovative treatments to patients. We constantly push ourselves to go above and beyond for patients, healthcare professionals, partners, and our team members.
Role and Responsibilities- Ensure continuous compliance of Mundipharma RA operations across diverse regulatory landscapes in the EU and Canada.
- Supervise RA delivery across multiple countries, utilizing both internal expertise and external vendor resources.
- Drive RA operations to meet business needs while respecting budget constraints.
- Develop and execute a robust RA data management strategy, offering valuable insights to internal and external stakeholders.
- Maintain data quality standards and compliance protocols, overseeing personnel responsible for data entry and upkeep.
- Ensure the integrity and effectiveness 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 inception to upkeep, ensuring alignment with business goals and budgetary boundaries.
- Create and convey a convincing RA systems strategy to senior management, garnering support for implementation plans.
- Proactively assess emerging technologies for potential integration into RA operations, promoting continuous enhancement and efficiency.
- Monitor regulatory changes, evaluating their impact on operations and devising strategies to manage risks and leverage opportunities.
- Oversee the global RA vendor strategy, monitoring vendor performance to ensure alignment with business requirements, compliance standards, and budget goals.
- BSc degree in life sciences.
- Significant experience as a regulatory professional is a must.
- Prior experience leading Regulatory Operations.
- In-country or above-country RA experience in EU or Canada.
- Familiarity with vendor oversight and outsourcing delivery models.
- Strong leadership and problem-solving abilities.
- Excellent communication skills and the capacity to effectively interact with Senior Leaders within the organization.
- Skilled collaborator and a focus on customer and stakeholder satisfaction.
- Thorough knowledge of regulatory systems and guidelines.
- Management and leadership of local regulatory delivery.
- Ability to identify emerging industry trends and incorporate best practices into Mundipharma's approach to RA data, systems management, and Operations.
- Flexible benefits package.
- Opportunities for learning and development.
- Collaborative, inclusive work environment.
Mundipharma is a global healthcare company operating across various regions worldwide. Committed to introducing innovative treatments to patients in Pain Management, Infectious Disease, Consumer Healthcare, and other severe illness areas. Our core values, focused on Integrity and Patient-Centricity, drive all our actions.
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