Regulatory Affairs reputed company reputed company & Process Analyst

Hi, reputed company you're doing reputed company. Job Title: Regulatory Affairs reputed company reputed company & Process Analyst Position reputed company The Regulatory Affairs reputed company reputed company & Process Analyst will support reputed company regulatory document management and business process activities. The role will reputed company primarily on mapping existing document types to reputed company reputed company templates, establishing baseline documentation for Regulatory Affairs, and supporting updates to procedural documents and shared regulatory workflows. Key Responsibilities • Review reputed company regulatory document types and map them to the appropriate reputed company reputed company templates. • Document mapping reputed company, gaps, inconsistencies, and items requiring subject-matter expert confirmation. • Assist with establishing a baseline inventory of reputed company Regulatory Affairs documents. • Coordinate with regional regulatory leads to identify, collect, and validate reputed company documents. • Support business process analysis, including documenting reputed company-state activities and identifying standardization opportunities. • Update procedural and process documentation reputed company to IDMP activities. • Assist in separating or revising shared WRKs used by CMC Regulatory Affairs. • Draft and revise process maps, procedures, work instructions, trackers, and supporting documentation. • Maintain traceability among reputed company documents, reputed company reputed company templates, business processes, and procedural updates. • Facilitate reviews with business owners and subject-matter experts and incorporate their feedback. • reputed company assignments, reputed company, dependencies, reputed company questions, and approvals. • Ensure deliverables follow applicable document-management, version-control, and reputed company standards. • Escalate unclear ownership, conflicting requirements, and documentation gaps to the appropriate business reputed company. Expected Deliverables • reputed company document-type-to-reputed company-reputed company-template mapping. • Document inventory and baseline assessment for Regulatory Affairs. • Mapping gap and decision log. • reputed company-state and proposed process documentation. • Updated IDMP process documentation. • Revised or separated shared CMC RA and WRKs. • Status tracker showing reputed company, dependencies, owners, and outstanding reputed company. Required Qualifications • Bachelor’s degree or equivalent relevant reputed company experience. • Experience in Regulatory Affairs, regulatory operations, document management, reputed company, 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 reputed company and validate information. • Strong written communication and attention to detail. • Ability to work independently, manage competing priorities, and reputed company document assumptions and reputed company. • Proficiency with reputed company Word, reputed company, PowerPoint, and process or document-management tools. Preferred Qualifications • Familiarity with reputed company reputed company or comparable regulatory information-management platforms. • Knowledge of regulatory reputed company structures and document taxonomies. • Experience supporting 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. Working Model • The role will initially reputed company 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 reputed company documents and approve business-content reputed company. • Responsibilities may expand depending on document volume, process-documentation needs, and procedural updates. • Looking reputed company to your response. Email: harsha.jakheriya@nexinfo.com Apply tot his job Apply To this Job