Regulatory Technologies Manager
il y a 3 jours
Regulatory Technologies Manager – 6-Month Contract
Position: Regulatory Technologies Manager
Contract Type: 6-Month Fixed Term
Industry: Regulatory Affairs / Life Sciences
Overview
We are looking for an experienced Regulatory Technologies Manager to lead a dedicated team in managing regulatory technology tools, ensuring these remain compliant with evolving standards, and acting as a critical liaison for regulatory affairs in IT projects. This role requires both a technical and strategic focus, with responsibility for operational compliance and cross-functional collaboration.
Key Responsibilities
1. Functional Management of Regulatory Technologies Team
- Provide leadership and direction to the Regulatory Technologies team, ensuring alignment with compliance goals and supporting operational needs.
2. Regulatory Compliance & Technical Solutions
- Keep abreast of industry and regulatory technology trends and requirements. Lead the design and implementation of technical solutions to ensure the organization meets all compliance standards.
3. Project Representation in IT Initiatives
- Represent regulatory affairs in IT-related projects, particularly those involving GED, eCTD viewers, and RIM tools. This includes:
- Requirement analysis and documentation
- Business impact assessments
- Overseeing deployment stages and supporting user testing.
4. Maintenance of Tool Compatibility
- Regularly assess and update all tools to ensure they remain compatible with current regulatory requirements and continue to meet compliance standards.
5. Development and Updating of SOPs
- Create, review, and revise Standard Operating Procedures (SOPs) for regulatory tools, ensuring these reflect the latest operational and compliance requirements.
6. Support for DSI Hotline
- Provide functional support for the regulatory tools via the DSI hotline, including user administration and handling user queries regarding tool functionality.
Expected Deliverables
- Guidelines and SOPs: Up-to-date operational guidelines and Standard Operating Procedures.
- Reports: Documentation for any project changes or upgrades.
- KPI Tracking: Metrics and reports on DSI hotline support and tool management activities.
Qualifications
Technical Skills
- Proficiency in tools such as Documentum, ENNOV DOC/DOSSIER, Eurs/esubmanager, Formavisa, Easyvista, Microsoft Office, and regulatory authority tools.
Soft Skills
- Strong leadership and team management capabilities.
- Analytical thinking with attention to detail in assessing project requirements and compliance.
- Excellent communication skills, enabling clear coordination across departments.
This role is ideal for a regulatory professional with technical expertise in managing compliance-related technology and a track record of successful project representation in IT initiatives.
If you’re ready to contribute your expertise to an impactful team, we’d love to hear from you.
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