Director of Regulatory Operations

5 dni temu

Poznań, Greater Poland GlaxoSmithKline Pełny etat

About the Role

We are seeking a highly skilled Senior Manager, Regulatory Operations to lead our Veeva Regulatory Vault team. As the Business System Owner (BSO), you will be responsible for overseeing the strategic management and continuous improvement of this business-critical system.

As BSO, you will ensure that Reg Vault is effectively supporting global regulatory operations, compliance, and business objectives. You will foster collaboration with other BSOs and systems, drive innovation, and ensure alignment with GSK's regulatory strategy.

This role requires strong leadership skills, technical expertise, and the ability to communicate effectively with cross-functional teams. If you have experience delivering business operational support to critical regulatory systems in a global environment, we encourage you to apply.

Key Responsibilities:

  • Strategic Leadership: Provide strategic direction and leadership to the team of Business System Owners, ensuring alignment with GSK's global regulatory operations and business objectives.
  • System Management: Oversee the management, maintenance, and optimization of key regulatory business systems to ensure they meet the needs of regulatory operations and compliance requirements.
  • Cross-Functional Collaboration: Collaborate with Regulatory Affairs, IT, Quality, and other cross-functional teams to ensure regulatory systems support end-to-end regulatory processes and business needs.
  • Innovation and Improvement: Drive continuous improvement initiatives for regulatory systems, leveraging new technologies and best practices to enhance system performance, user experience, and data integrity.
  • Compliance and Risk Management: Ensure regulatory systems comply with global regulatory requirements and internal standards, and proactively identify and mitigate risks associated with system usage and data management.
  • Project Oversight: Oversee the planning, execution, and delivery of projects related to regulatory system enhancements, upgrades, and new implementations, ensuring they are completed on time and within budget.
  • Resource Management: Manage resources effectively, including budget, personnel, and technology investments, to support the successful operation and enhancement of regulatory systems.
  • Training and Development: Develop and implement training programs for Business System Owners and other stakeholders to ensure they are proficient in using regulatory systems and aware of best practices.
  • Performance Monitoring: Monitor and evaluate the performance of regulatory systems, using key performance indicators (KPIs) and metrics to ensure they meet business needs and regulatory requirements.
  • Stakeholder Communication: Serve as the key point of contact for regulatory system-related matters, providing regular updates and communications to senior management, stakeholders, and regulatory authorities as needed.

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