6 Lorenz Docubridge Jobs

Job Description Business: Critical Care Department: Regulatory Affairs Location: Kurla, Mumbai Travel: Low Job Overview Manage the team of Publishing expert(s), Manage the preparation, review, and submission of various electronic applications to the Food and Drug Administration (FDA), European Union (EU) and other regulatory bodies in accordance with government legislation, relevant guidelines, standards and national requirements. Provides guidance, supervision and leadership of subordinates. Support the vision for Regulatory Operations into the future Key Stakeholders: Internal: Cross-Functional: Regulatory New Products Team, Regulatory Life Cycle Management Team, Medical Affairs, Pharmacov...

RA Profile (EU Market Filing and Query & Response) Department: Regulatory Affairs Reporting to: Senior Director Global Regulatory Affairs Job Location: Bangalore Industry: Pharmaceuticals Key Responsibilities Regulatory submissions to the EU Market and Query Response subsequently comply with applicable regulatory requirements Compile and review all documents required in line with the relevant guidelines. Coordinate with relevant departments and prepare submissions. Perform detailed regulatory review and assessment of all documents, gather required data as needed to develop/finalise the documents, coordinate and prepare submissions Review technical reports, summary documents and change contro...

Key Responsibilities: Strong understanding of eCTD, NeeS, and ICH guidelines. Familiarity with Regulatory systems and Publishing tools. Use publishing tools such as: Lorenz Docubridge, Ectd Validator, ISI Toolbox, Adobe Acrobat, MS Excel, SharePoint. Ability to perform end-to-end eCTD submission process, including Document level Publishing and Dossier compilation, and dispatch of submissions to respective Health Authorities (Developed and ROW Markets) Manage lifecycle submissions including variations, amendments, and renewals. Perform document-level publishing, hyperlinking, bookmarking, and validation. Conduct quality control checks to ensure submission readiness. Collaborate with cross-fun...

Role Overview The Sr. Associate IS Analyst DocuBridge will play a critical role in the implementation, support, and lifecycle management of structured regulatory submission solutions, primarily focused on Lorenz DocuBridge. This position requires strong technical and regulatory knowledge, project execution capabilities, and hands-on system expertise. The candidate will work closely with Regulatory Affairs, IT, Quality Assurance, and vendor partners to deliver compliant, efficient, and scalable submission systems aligned with global health authority requirements. Roles & Responsibilities Support the implementation and system management of the Lorenz DocuBridge Suite, ensuring alignment with g...

Role Overview The Sr. Associate IS Engineer CTRS will support the Regulatory and Clinical Trial Submission (CTRS) product team by designing, developing, and maintaining software solutions to meet critical business needs. The role involves close collaboration with product managers, designers, engineers, and vendor partners, with a focus on applications like Disclose from Citeline and docuBridge Suite from Lorenz. The ideal candidate will bring hands-on technical expertise along with deep knowledge of regulatory submissions and clinical trial disclosure systems, playing a key role in maintaining application performance, compliance, and innovation. Roles & Responsibilities Design, develop, and ...

Hi We are hiring for Regulatory Submissions Publisher . Job Purpose: Build and process submission dossiers of low-to-moderate complexity: Submission Dossiers that may be periodic (e.g.: safety reports) or minor amendments (e.g.: IND Amendment, DMF Amendment, CMC Update as appropriate to level, etc) or otherwise not major applications but in support of pending approvals or lifecycle commitments for marketed products (e.g.: meeting packages, responses as appropriate, Advertising and Promotion Submissions, routine labeling updates as appropriate, etc.) QC submission dossiers or parts of submission dossier output of low-to-moderate and moderate-to-high complexities as assigned. Other submission ...