Stellenbeschreibung

Senior Regulatory EU Submissions Team Leader – Stuttgart – Permanent (€90.000) I am currently working with a client based in Stuttgart and specialised in Regulatory Affairs Submissions for Europe. They are looking for an experienced Regulatory Affairs Team Leader to join their team for a permanent position. This role will require strong management skills and a proven track record in Regulatory Affairs and Submissions at international level. Responsibilities: * Manage and oversee the coordination and preparation of registration processes for European Region (incl. EEA, CIS, Balkans) submissions assigned to Team. * Ensure that the documentation prepared/compiled by team is complete and complies with applicable regulatory requirements. * Tracking the European region submission progress and MAs related data via setting efficient communication rules with national competent authorities/ local agents. * Ensure that timely responses to the regulatory queries raised during the evaluation process are provided by the team to the national competent authorities/ local agents. * Appraise company of developments in  EU regulation/legislation. * Ensuring that the Change Control  requests are assessed vs. ICH/EU requirement and regulatory impact assessment is performed and communicated. * Lead cross function meetings and processes with regard to implementation of EU/ICH regulatory requirements, in order to obtain timely regulatory approvals for the products as part of the product development/registration strategy planning. * The role will also involve department / people management - Overall management of a team of 10 Junior to Senior Regulatory Affairs Officers. Requirements: * A good degree in a Life Science-related subject * Proficient level of English. Spanish and German   knowledge desired * Minimum 5 years EU Submissions experience with management/ supervisory experience. * Strong working knowledge of EEA, US, non-EU regulatory requirements and procedures required. This includes good understanding of eCTD requirements. * Experience of working in accordance with GXP quality standards. * Ability to prioritise decisions and activities to ensure efficient use of resources and address critical issues impacting the business* Professional fluency in English and German The candidate will be working within an environment with an international outlook, manage the complete European submissions process and focus on achieving  long term account goals in line with the company vision and values.