Sr. Specialist, System Process & Regulatory Innovation

The Senior Specialist Regional System Process & Regulatory Innovation (SPRI) is an individual contributor within the Regional Regulatory Operations Asia Pacific (RRO AP) department part of our companys Global Regulatory Affairs and Clinical Safety (GRACS) organization.

This role is responsible for the operational execution and support of regulatory systems processes and digital initiatives across the APAC region while progressively expanding exposure to regional strategy and governance activities within established frameworks.

The Senior Specialist applies technical and functional knowledge of regulatory systems and business processes and works closely with Regulatory Innovation & Information Management (RIIM) Business System Owners (BSOs) and key regional stakeholders to deliver assigned system-related activities and project workstreams.

In addition to core delivery responsibilities this role contributes to selected regional initiatives governance activities and strategic inputs under guidance supporting alignment with global and regional priorities. The Senior Specialist will progressively build capability in identifying improvement opportunities and supporting change initiatives while maintaining accountability for execution data quality and compliance within defined governance structures.

All activities are performed under established procedures defined governance and within regional and global system and process frameworks.

Key Responsibilities

• Execute and own delivery of assigned system process and data-related activities and initiatives end-to-end including day-to-day operations project workstreams and defined improvement efforts.

• Ensure timely execution stakeholder alignment and adherence to governance and compliance requirements.

• Provide end-user support and enablement across regulatory systems and processes including:

  • Handling inquiries

  • Supporting data entry and process adherence

  • Contributing to training and communication materials

  • Promoting consistent and compliant system usage across the region

• Drive data quality and continuous improvement activities including:

  • Monitoring and root cause analysis

  • Implementing corrective actions

  • Identifying opportunities to enhance workflows documentation system usage and data integrity

• Support system implementation enhancements and change activities including:

  • Preparation of deliverables

  • Testing validation and user acceptance

  • Documentation updates

  • Execution of defined changes to ensure adoption

• Contribute to governance and strategy activities within defined scope including:

  • Preparing regional inputs

  • Participating in governance forums

  • Providing data-driven insights for decision-making under guidance

• Represent the region in selected forums working groups or communication platforms as assigned

• Collaborate with SPRI colleagues and cross-functional stakeholders to:

  • Align activities

  • Share best practices

  • Support regional goals

  • Identify automation and optimization opportunities

Role Scope

• Individual contributor role

• No formal people management responsibilities

• No budget ownership

• No accountability for regional strategy

Education

• Bachelors degree in Science Information Technology Pharmacy or a related discipline required

Required Experience & Skills

• Minimum 3 years of experience in:

  • Regulatory Affairs

  • Regulatory Operations

  • System/process-related roles supporting regulatory systems and digital initiatives

• Working knowledge of regulatory business processes including:

  • Submission planning and execution

  • Regulatory information management

• Experience in:

  • System implementation

  • Testing and validation

  • User support activities

• Ability to manage multiple tasks and priorities in a matrix environment

• Strong communication and collaboration skills to engage with regional and cross-functional stakeholders

• Experience in:

  • Data quality initiatives

  • Process improvement

  • System enhancements

Preferred

• Experience in:

  • Project management methodologies

  • Change management

  • Process re-engineering

  • Analytics and reporting tools (e.g. Cognos PowerApps ChatGPT)

  • Training material development and communication strategies

Language Requirements

• Fluent in English