Sr. Specialist, System Process & Regulatory Innovation

Job Description

Senior Specialist System Process & Regulatory Innovation (SPRI)

The Senior Specialist SPRI supports the regional activities associated with the implementation and support of Global Regulatory Affairs Compliance and Safety (GRACS) Digital Strategy projects and systems.

The role focuses on regulatory content and submission management submission planning and execution and regulatory information/health registration systems.

You will work across all countries in the region partnering with Regulatory Innovation & Information Management (RIIM) Business System Owners (BSOs) Business Process Owners (BPOs) and key regional stakeholders to ensure systems meet regional and country-specific needs and that processes and capabilities are continuously improved.

Digital skills (e.g. Microsoft Power Platform Gen AI) and a strong interest in regulatory technology and process excellence are highly valued.

What You Will Do:

• Support regional implementation adoption and enhancement of GRACS regulatory systems and digital capabilities.

• Act as primary contact (or secondary support) for regional users on system usage business processes and process improvement initiatives; provide user training as needed.

• Understand underlying business processes; work with BPOs to adapt procedures to regional and local regulatory requirements.

• Evaluate regional data identify data quality and compliance issues and develop/implement action plans.

• Ensure timely regional input and delivery of tasks for global projects.

• Contribute to regional and global projects that enable regulatory and business strategies particularly those involving process digitization and automation.

• Collaborate with RAI iCMC GRACS O.P.S PV and other GRACS functions to deliver regional objectives.

• Translate regional needs and external changes into actionable plans aligned with the GRACS Digital Strategy; support communications and change management activities.

• Provide direct support for GRACS RIIM tools: promote good data management practices deploy automations for standardized tasks and support systemprocess improvement collaborations.

• Organize/participate in regional communication forums to share updates on processes and system changes.

• Represent regional needs in Change Control Boards and Communities of Practice.

• Support development and delivery of global/regional regulatory training and refresher sessions.

• Provide periodic operational metrics and dashboards; report progress on regional objectives and strategic initiatives.

• Work with other Regional SPRI staff to align activities share best practices and identify automation-based solutions.

What You Must Have:

Education

• Bachelors degree in a science information technology Pharmacy or related discipline required.

• Advanced degree (engineering or scientific discipline MBA) preferred.

Required Experience & Skills

• With around 24 years experience in Regulatory Affairs Regulatory Operations and/or pharmaceutical manufacturing with at least 3 years experience implementing and/or supporting regulatory information systems.

• Demonstrated ability to lead and influence without direct authority; strong organizational awareness.

• Ability to prioritize and manage work across multiple concurrent projects.

• Proven problem-solving skills; experience analyzing information and implementing actions to improve data quality processes or systems.

• Experience in project management methodologies change management process re-engineering analytics and reporting (e.g. Cognos PowerApps ChatGPT) training material development and communications is beneficial.

• Strong critical thinking collaboration Communication and stakeholder engagement skills.

Language

• Fluent in English; fluency in a relevant regional language is an advantage.

Required Skills:

Preferred Skills:

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