Regulatory Affairs Assistant focused on pharmaceutical - related logistics at PINEX. Engaging in regulatory analysis, documentation, and compliance monitoring.
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
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
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