Senior Manager, Development and Regulatory

**Site Name**: Poznan Grunwaldzka, Mexico City Torre Mitikah, Mississauga Milverton Drive, Warsaw Rzymowskiego 53
**Posted Date**: Oct 31 2024
**Senior Manager, Development and Regulatory Operations**

This role leads a group of Business System Owners (BSOs) at GlaxoSmithKline (GSK) and is responsible for overseeing the strategic management and continuous improvement of key regulatory business systems. Additionally, this role serves as the BSO for the Content Generation Service (CGS) app which is a tool leveraging AI and built on the Mendix platform that creates draft regulatory documents. This app is a key part of GSK’s hyper-acceleration strategy, which aims to dramatically speed the process of getting new products into the hand of patients that need them.

BSOs ensure that all regulatory systems are effectively supporting global regulatory operations, compliance, and business objectives. The Senior Manager leads a team of BSOs, fostering collaboration, driving innovation, and ensuring alignment with GSK’s regulatory strategy. By optimizing the performance and integration of regulatory systems, the Senior Manager enhances operational efficiency, data integrity, and regulatory reporting, ultimately supporting GSK’s mission to deliver high-quality products to patients worldwide.

**Locations: Poland (Poznan, Warsaw), Mexico City, Milverton (Canda)**

**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.

**Why you?**

**Basic Qualifications**:

- A Bachelor’s degree in a relevant field such as Life Sciences, Pharmacy, Regulatory Affairs, Information Technology, or a related discipline is required
- Relevant professional certifications such as Regulatory Affairs Certification (RAC), Project Management Professional (PMP), or certifications in IT systems management or data governance
- Experience delivering business operational support to critical regulatory systems in a global environment (Regulatory Information Management and Reporting, Electronic Publishing and Validation Systems, Electronic Data Exchange and/or Labeling Management Systems)
- Lead and participated in Business Change Teams delivering IT solutions for the business
- Extensive experience of working within a regulated project delivery environment
- Ability to communicate and provide assistance and support on both sides of the Business-IT interface
- Proven ability to interact effectively with senior managers within the organization
- Experience managing change control and system lifecycle within a regulated environment, ideally in drug / vaccines development
- Experience in Business Analysis and Business Process Design
- Fluent and able communicator in English and local language
- Strong communication and influencing skills
- Ability to self-manage the work and prioritize effectively
- Service orientation, customer-focused
- Good team worker, but with confidence to lead when appropriate
- Good understanding of IT