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Regulatory Operations and Publishing Manager (f/m/d)
Garching bei München
Aktualität: 05.10.2022


05.10.2022, ITM Oncologics GmbH
Garching bei München
Regulatory Operations and Publishing Manager (f/m/d)
Administer and Monitor Regulatory Operations systems (e.g. Veeva) and ensure they are being managed properly and working in compliance with existing regulations Work closely with Clinical and CMC Regulatory Affairs, cross-functional teams and relevant vendors to provide operational oversight and support for the planning, preparation, tracking, and timely submission of all regulatory applications and updates to global health authorities (e.g. IND, NDA, MAA, post approval submissions) Plan, execute and track regulatory submissions in timely manner within RIM system including compilation and publishing of electronic regulatory applications, mainly in the eCTD format Serve as a point of contact for regulatory publishing activities for ITM products; ensure all formatting and document completeness Report to Regulatory Leads on deliverables for major milestone submissions Manage use of Regulatory Operations tools (e.g. SharePoint, Adobe, Acumen Stylus) for record management and publication Assist in the ongoing set-up of a newly implemented RIM system Troubleshooting of technical issues that impact validation requirements within RIM system Archive Health Authority communications and tracking of questions and commitments within Veeva RIM Execute RIM user role as minimum and other roles, as required Maintain and review records and data in the RIM system Support development of internal process documentation including SOPs, work instructions, and best practices on regulatory information system and regulatory publishing topics
Degree in life science; further training in drug regulatory affairs would be a strong plus Minimum 2-3 years of proven practical experience with regulatory publishing and submissions in eCTD format and within any common regulatory content management system; a proven knowledge of Veeva Vault would be a clear asset Knowledge of key regulations, guidelines, and format specifications, at least those of EMA, FDA, and ICH Advanced knowledge in preparing guideline and authority conform submission documents Good verbal and written communication skills in both, German and English Strong interpersonal skills and the ability to work independently, strong service-oriented attitude, team player Strong attention to details as well as efficient time management and expressed prioritization skills