Remote Solution Architect Regulatory Information Management (RIM)//(AV)

Location: Remote 

Experience: 15+ years                                                                                                                                                                                

Job Description:

The Solution Architect will be responsible for the end-to-end architecture, design governance, integration strategy, data migration approach, and technical leadership for the implementation of the Ennov RIM platform. The role will work closely with Regulatory Affairs, Quality, Enterprise Architecture, Data, Integration, Security, and Vendor teams to ensure successful deployment and alignment with enterprise standards.

The RIM platform is expected to enable regulatory registrations, submissions, publishing, archival, workflow automation, and integration of regulatory data across the enterprise.

Key Responsibilities

• Solution Architecture & Design
• Configure master data to support regulatory submission identification, templates and analysis
• Configure submission templates (to accelerate construction of submissions)
• Configure submission workflow templates (to assure routing for review and approval in the most efficient manner)
• Configure supporting templates and workflows, such as Regulatory Correspondence
• Configure submission archiving
• Deliver reporting and dashboards for both master data and the submissions process (dashboards)
• Deliver integration to support Master Data updates
• Deliver integration to support submissions development (e.g. data files, studies reports)
• Perform data migration of in-scope completed submissions, attaching migrated submissions to appropriate master data and disposition

Required Qualifications

Enterprise application architecture experience.

Solution Architect for enterprise software implementations.

Prior experience implementing:

Regulatory Information Management (RIM)

Regulatory Affairs applications

Quality Management Systems

Clinical or Life Sciences platforms

Regulatory Domain Experience

Strong understanding of:

Regulatory Affairs processes

Submission management

Product registrations

Regulatory correspondence

Submission publishing

Regulatory archives

Compliance and audit requirements