Regulatory Operations and Systems Manager

The appointed Regulatory Operations and System manager will make proposals for appropriate software solutions and systems to support business processes including publishing and electronic filings to key authorities and archiving. The chosen candidate will be responsible for the maintenance of software. Responsibility will include the planning, creation and despatch of high-quality CTD and eCTD dossiers, training authors on and assisting them with source document formatting. Currently the function manages regulatory affairs’ archiving, SOPs and regulatory information (RIM) and IDMP conform data bases.

Responsibilities will include:

• Confirming compliance of paper, NeeS and electronic dossiers with health authority requirements worldwide with the aim to be fully electronic wherever and whenever possible
• Appropriate publishing and dispatch of paper, NeeS and electronic dossiers to health authorities worldwide               
• Identifying system requirements as well as defining and delivering well-suited solutions that meet the needs of authors regarding the preparation and management of source documents, the planning and tracking of submissions, the viewing and archiving of dossiers
• Generating and maintaining SOPs and manuals for the RA department as required
• Maintaining and evolving electronic publishing systems for paper and electronic dossiers
• Maintaining appropriate and compliant archiving solutions for the RA department.
• Implementing new regulatory affairs systems, tools and data bases (e.g. regulatory information management, document management)
• Managing third party vendors of systems and services
• Manages permanent and temporary staff in the function

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Salary: Competitive + Package

For further information please get in touch with our lead consultant Natalie Jones on 0207 183 5059 or email your details directly to natalie@linkfieldgroup.com