Hybrid Senior Specialist, System Process & Regulatory Innovation

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About the role

  • Senior Specialist managing regional regulatory projects and supporting compliance systems for healthcare company. Implementing digital strategy initiatives and collaborating with stakeholders through process improvement.

Responsibilities

  • 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
  • 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
  • Organize/participate in regional communication forums to share updates on processes and system changes
  • Support development and delivery of global/regional regulatory training and refresher sessions

Requirements

  • Education: Bachelor’s degree in a science, information technology, Pharmacy, or related discipline required
  • Advanced degree (engineering or scientific discipline, MBA) preferred
  • Required Experience & Skills: Around 2–4 years’ experience in Regulatory Affairs, Regulatory Operations, and/or pharmaceutical manufacturing
  • At least 3 years’ experience implementing and/or supporting regulatory information systems
  • Demonstrated ability to lead and influence without direct authority
  • Strong organizational awareness
  • 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)
  • Strong critical thinking and collaboration skills
  • Fluent in English; fluency in a relevant regional language is an advantage.

Benefits

  • Flexible Work Arrangements: Hybrid
  • Professional Development opportunities

Job title

Senior Specialist, System Process & Regulatory Innovation

Job type

Experience level

Senior

Salary

Not specified

Degree requirement

Bachelor's Degree

Tech skills

Location requirements

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