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Lieu :

Les Ulis, France

Descriptif :

Contract: 6 months initial period

Location: Les Ulis, France ; home based flexibility is possible
Rate: up to €525 per day
ID: OM113281

We are seeking a Regulatory Processes and Compliance Manager to work in a Quality Assurance position for a biopharmaceutical company in France.

The overall purpose of the position is:
• Close collaboration with the Regulatory Affairs (RA) Community and other R&D departments
• Ensure consistency across regulatory processes and other R&D processes when Global RA is impacted
• Lead teams developing/revising RA Quality System documents (SOPs, etc.)
• Develop KPIs on processes, monitor compliance, develop mitigation actions when needed.
• Ensure and master training on processes
• Interact with other departments to share information within the Organisation to foster growth of Regulatory compliance in knowledge and practice

The role will have multiple dimensions, including:
• Oversight of Regulatory Quality Documents
• Overview on documents impacting RA
• GRA Quality system
• Project Management
• Training on Regulatory Processes
• Metrics Development and Compliance

Experience / Qualifications:
• Strong professional experience in a relevant position, including experience in Corporate Regulatory Affairs or Quality Assurance.
• Capable of delivering key communications with clarity and impact.
• Solid project management skills
• Good experience of matrix working – this role will involve facilitating groups of individuals to work together on innovative regulatory solutions.
• Good personal and negotiation skills - ability to build networks and secure appropriate support for a project.
• Able to identify issues in advance, implement actions to resolve them and to manage contingencies.
• Able to derive creative solutions to regulatory problems, while balancing the expectations of Agencies and ensuring compliance with regulation in all regions.
• An eye for continuous improvement opportunities in all tasks.

Application / Contact:
Please send a copy of your CV with some covering information, describing your motivations and suitability for the position to:
Upon application, you will be sent a full copy of the job description.
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