Regulatory Publishing Specialist

Regulatory Affairs Professional Job DescriptionOur team seeks a skilled Regulatory Affairs Associate Senior to lead the publishing and dispatch of regulatory submissions for Devices & Drugs Submissions. Key responsibilities include:Managing and leading regulatory publishing operations globally.Ensuring submissions meet eCTD requirements and other regional...

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...

Familiarity with using publishing tools such as: Mono eCTD, Ectd Validator.Perform end-to-end eCTD submission process, including Document level Publishing, dossier compilation, hyperlinking, bookmarking, and validation and quality checking.Health insurance

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...

Position Details: Position Title: Preflight Specialist Experience Required: 5 to 10 years Location: Marathahalli, Bangalore Shift Timing: 2:00 PM – 11:00 PM IST (Hybrid) Note: Cab facility is provided for drop Employer: Global Product Company - Established 1969 Why Join Us? Be part of a global product company with over 50 years of innovation....

Is responsible for importing, creating, publishing and performing documented QC checks on PSRs located in electronic document management system (eDMS) for PV; creating electronic compliant published reports for submissions to regulatory agencies and troubleshoots any issues that occur in eDMS and other publishing systems. Trains and mentors new internal and...

Job Opportunity:We are seeking a skilled Publishing Coordinator to join our team. This individual will play a pivotal role in ensuring the seamless execution of publishing workflows from manuscript submission to final production.The Publishing Coordinator will collaborate with editorial teams, authors, designers, and vendors to meet publishing timelines,...

Regulatory Affairs SpecialistThis role is a great opportunity for individuals with a strong understanding of regulatory affairs and a passion for ensuring compliance. The Regulatory Affairs Specialist will play a critical role in assisting international regulatory teams with navigating evolving business needs in the Indian market.Key...

Job Title:Regulatory Compliance SpecialistAs a Regulatory Compliance Specialist, you will be responsible for preparing and reviewing regulatory packages for authority meetings. This includes conducting rehearsals and participating in meetings as required.Main Responsibilities:Manage Change Requests (CR), Non-conformities (NC), and CAPA cases within area of...

Job Title: Regulatory Affairs Specialist">Job Description:">We are seeking a highly motivated and detail-oriented Regulatory Affairs Specialist to manage and support regulatory submissions, ensure compliance with global regulatory requirements, and maintain the highest standards of operational excellence in regulatory processes.">Technical skills: Deep...