The Global Regulatory Operations Reporting Senior Specialist at GlaxoSmithKline (GSK) plays a critical role in supporting regulatory operations on a global scale by gathering, analyzing, and documenting business requirements to drive efficient and compliant solutions. This role ensures that regulatory systems and processes align with business objectives and meet regional regulatory requirements. The Business Analyst works closely with cross-functional teams, including Regulatory Affairs, IT, Quality, and other key stakeholders, to identify needs, define requirements, and deliver solutions that enhance operational efficiency and data integrity. By leveraging strong analytical skills, stakeholder collaboration, and innovative problem-solving, the Business Analyst enables GSK to effectively navigate the complex regulatory landscape, supporting the successful registration, lifecycle management, and compliance of GSK’s products worldwide.

Key Responsibilities:

Stakeholder Engagement and Collaboration:

• Serve as a liaison between business stakeholders and technical teams, providing guidance and expertise to ensure alignment of business objectives with regulatory operations.
• Foster productive relationships with cross-functional teams, including Regulatory Affairs, IT, Quality, and other stakeholders, to gather input and ensure shared understanding of requirements.

Requirements Gathering and Documentation:

• Lead efforts to elicit, analyze, and document business requirements for regulatory systems, processes, and tools.
• Develop clear and detailed requirement specifications that serve as the foundation for system design and process improvements.

Data Integrity and Quality:

• Collaborate with stakeholders to ensure the accuracy, completeness, and integrity of regulatory data utilized in operations and compliance activities.
• Define data validation requirements and processes to uphold quality standards.

Regulatory Compliance:

• Ensure all solutions and processes align with applicable regulations, guidelines, and standards

Process Improvement:

• Identify and recommend opportunities for streamlining regulatory operations processes, ensuring alignment with industry best practices and innovative solutions.
• Document "as-is" and "to-be" process flows to support continuous improvement efforts.

Technology Utilization:

• Partners with IT and technical teams leverage advanced analytics, data visualization tools, and business intelligence platforms to facilitate decision-making and enhance process efficiency.

Project Coordination:

• Support project management activities by tracking progress, identifying risks, and ensuring timely delivery of regulatory solutions and initiatives.
• Act as a key contributor in Agile or Waterfall project methodologies, depending on the initiative.

Training and Knowledge Sharing:

• Develop and deliver training materials and sessions for stakeholders to ensure understanding and effective use of regulatory systems and processes.
• Document lessons learned and shared best practices to enhance organizational knowledge.

Risk Analysis and Mitigation:

• Conduct risk assessments related to regulatory operations processes and propose mitigation strategies to ensure compliance and operational excellence.

Strategic Alignment:

• Work closely with leadership to align regulatory operations initiatives with GSK’s overall business strategy, ensuring long-term value and success.

Basic Qualifications:

• Around 5 years of experience in Business Analysis and Business Process Design.
• 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 with DevOps model for application of continuous improvement of deployed Power BI dashboards.

It is essential that the candidate has experience of managing/supporting regulatory business IT systems. Some experience with business system ownership and business system lifecycle management is preferred.

 

Benefits:

• Career at one of the leading global healthcare companies
• Contract of employment
• Attractive reward package (annual bonus & awards for outstanding performance, recognition awards for additional achievements and engagement, holiday benefit)
• Life insurance and pension plan
• Private medical package with additional preventive healthcare services for employees and their eligible
• Sports cards (Multisport)
• Possibilities of development within the role and company’s structure
• Personalized learning approach
• Extensive support of work life balance
• Supportive community and integration events
• Modern office with creative rooms, fresh fruits everyday
• Free car and bike parking, locker rooms and showers.

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Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

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