Regulatory Affairs Specialist

About Nexinfo
NexInfo is a consulting firm focused on improving business processes and automation in the Supply Chain and Product Lifecycle Management sectors.
We offer services in business process design, software implementations, managed services, staff augmentation, and SaaS solutions. We aims to help businesses across industries achieve their goals through industry best practices, lean process design and advanced software solutions. Our ERP-related services address challenges such as inventory management,
product lifecycle management, demand management, forecasting, sales and operations planning, business intelligence, security compliance, and financial alignment.

• Review regulatory document types and map them to the appropriate Active Dossier templates.
• Document mapping decisions, gaps, inconsistencies, and items requiring subject-matter expert confirmation.
• Assist with establishing a baseline inventory of current Kite Regulatory Affairs documents.
• Coordinate with regional regulatory leads to identify, collect, and validate current documents.
• Support business process analysis, including documenting current-state activities and identifying standardization opportunities.
• Update procedural and process documentation related to IDMP activities.
• Assist in separating or revising shared WRKs used by Gilead CMC Regulatory Affairs
• Draft and revise process maps, procedures, work instructions, trackers, and supporting documentation.
• Maintain traceability among source documents, Active Dossier templates, business processes, and procedural updates.
• Facilitate reviews with business owners and subject-matter experts and incorporate their feedback.
• Track assignments, decisions, dependencies, open questions, and approvals.
• Ensure deliverables follow applicable document-management, version-control, and quality standards.
• Escalate unclear ownership, conflicting requirements, and documentation gaps to the appropriate business lead.

• Gilead/Kite document-type-to-Active-Dossier-template mapping.
• Document inventory and baseline assessment for Kite Regulatory Affairs.
• Mapping gap and decision log.
• Current-state and proposed process documentation.
• Updated Kite IDMP process documentation.
• Revised or separated shared Gilead CMC RA and Kite WRKs.
• Status tracker showing progress, dependencies, owners, and outstanding decisions.

• Bachelor s degree or equivalent relevant professional experience.
• Experience in Regulatory Affairs, regulatory operations, document management, quality, or business process analysis.
• Experience working in a pharmaceutical, biotechnology, life-sciences, or similarly regulated environment.
• Strong document analysis, classification, mapping, and organizational skills.
• Experience drafting or updating procedures, work instructions, process maps, and controlled documents.
• Ability to work with regional leads and subject-matter experts to gather and validate information.
• Strong written communication and attention to detail.
• Ability to work independently, manage competing priorities, and clearly document assumptions and decisions.
• Proficiency with Microsoft Word, Excel, PowerPoint, and process or document-management tools.

• Familiarity with Active Dossier or comparable regulatory information-management platforms.
• Knowledge of regulatory dossier structures and document taxonomies.
• Experience supporting Kite, Gilead, or comparable cell-therapy and pharmaceutical regulatory organizations.
• Familiarity with IDMP processes and documentation.
• Experience with CMC Regulatory Affairs.
• Familiarity with controlled-document governance, change control, and version management.
• Experience working across global or regional regulatory teams.

• The role will initially focus on document mapping and early business-process assignments.
• The individual will work under the direction of designated Regulatory Affairs business owners.
• Regional leads and subject-matter experts will identify or validate source documents and approve business-content decisions.
• Responsibilities may expand depending on document volume, process-documentation needs, and procedural updates.

Thanks and Regards,

Joseph