Submission Publishing Specialist

Job Title:Regulatory Affairs Manager - Submission PublishingJob Description:We are seeking a proactive leader to head our Submission Publishing team. This individual will be responsible for delivering high-quality regulatory submissions while ensuring compliance with global health authority requirements.This role involves managing a high-performing team,...

Job Title: Regulatory Publishing SpecialistWe are seeking a skilled Regulatory Publishing Specialist to join our team in preparing and managing Biologics License Applications in eCTD format using Veeva Vault eCTD Publishing.The ideal candidate will have strong experience in Veeva Vault eCTD Publishing for Biologics License Application submissions, as well as...

Regulatory Submission ManagerThis role involves managing a team to deliver high-quality regulatory submissions while ensuring compliance with global health authority requirements. This includes optimizing processes, troubleshooting technical issues, and collaborating with cross-functional stakeholders to drive operational excellence.Responsibilities:Lead and...

Job DescriptionThe Manager will drive high-quality submissions in compliance with technical requirements.Key Responsibilities:Resolve errors, challenges, and roadblocks to ensure quality output.Collaborate with teams and stakeholders to drive quality outputs.Work closely with the team to identify process improvements and efficiency gains.Technical Competency...

Senior Document Publishing SpecialistThe primary responsibility of this role is to serve as a single point of contact for the authoring community and subject matter expert in delivering submission-ready documents.Main ResponsibilitiesThis individual will coordinate operational aspects of document-level support activities, including collaborating closely with...

Position Requirements:● 1 to 2 years of experience in Editorial, Project Management, or Operations working in a high-volume, process-oriented environment with a focus on online contentdevelopment, preferably in a medical communications agency, pharmaceutical company, or pharmaceutical advertising agency● 1 to 2 years of experience submitting promotional...

Job Summary:We are seeking a highly skilled Publishing Coordinator to join our publishing team. The successful candidate will be responsible for coordinating the end-to-end publishing process, from manuscript submission to final production.Key Responsibilities:Coordinate the entire publishing process, ensuring timely delivery and high-quality...

Key Responsibilities:Prepare and manage BLA (Biologics License Application) submissions in eCTD format using Veeva Vault eCTD Publishing.Compile, format, and publish regulatory documents according to global health authority requirements.Ensure compliance with regulatory guidelines (FDA, EMA) and internal processes.Perform QC of eCTD submissions, including...

RESPONSIBILITIESBook-in, Data Entry and Quality Reviewer of ICSR in Argus databaseICSR Global Submission (Timelines and Submission Process)Vendor ManagementSOP training in department as and when neededDESIRED SKILLSGood knowledge about GVP (Good Pharmacovigilance Practices) modules and guidelines.Good knowledge about timelines and submission process of...

Responsibilities: Coordinate end-to-end publishing workflows, from manuscript submission to final production. Collaborate with editorial teams, authors, designers, and vendors to ensure publishing timelines are met. Perform quality checks on content, layouts, and design before release. Assist in preparing content for digital and print distribution,...