Ensure preparation, validation, dispatch and submission of compliant and high quality initial, 2nd wave and maintenance Regulatory filings according to submission plans.
Update respective Regulatory systems for Registration Management, Publishing and Document Management. Support the Global Regulatory teams during the product development phase and provide input as appropriate Follow Regulatory procedures and timelines
Support regulatory teams during the submission process in all administrative and technical steps according to global procedures Prepare and dispatch / submit documentation packages for predefined submission types and region(s) in compliance with Health Authority requirements Ensure eCTD lifecycle maintenance according to ICH and regional specifications Ensure timely update of submission data in the regulatory information management databases and verify that the data is kept compliant Be involved in the timely and efficient processing of regulatory, submission-
relevant documents like M1, eApplication Form, COPPs, GMP Certificates Maintain communication network with regulatory functions like RCCs, MRCc and country organizations and non-
regulatory stakeholders according to guidance documents Ensure escalation procedures are followed in case of issues and delays Might be involved in document preparation activities like scanning, bookmarking, linking and other activities to ensue document submission readiness Might be involved in document bulk upload activities
Key Performance Indicator
1.KPIs like on-time filing dispatch / submission, submission rejection rate, customer satisfaction (e.g. regulatory competence, responsiveness) 2.
All assigned project deliverables meet targets for quality, productivity in compliance with Regulatory and / or health authorities requirements 3.
Delays in launches and supply caused by GRA (None) 4.Regulatory compliance
University or College Degree in any field or life science with relevant industry experience or comparable degree Good communication in English (oral and written).
At a minimum 2 years’ experience in the Pharmaceutical area, specifically in Regulatory Operations Experience in the Regulatory submission publishing, area is preferred Knowledge of Regulatory guidelines for the areas mentioned above Organizational awareness and experience working cross-
functionally and in global teams is a plus Ability to work under pressure, demonstrating initiative and flexibility High level understanding of Regulatory quality, standards and policies.
Attention to detail and quality focused Team-minded