We have a clear commitment: putting best-possible solutions in the hands of medical professionals, enabling them to find the right answer to the challenge they face. Fresenius Kabi is a driver of healthcare for the coming decade. We truly live diversity and value different backgrounds and motivations....+ ← Eysins / International · Permanent · Full-time · As of now Biosimilars Regulatory Project and Submission Specialist (Intern) Job Summary Functional Goal: * Leads and contributes to the design, development, maintenance and improvement of all processes, activities and systems contributing to the successful and timely submission of dossiers. Main Tasks: * Under supervision take ownership of the operations tasks for submissions up to their submission to the HA. * Participate actively in the coordination of the planning and management of submission related documents, regulatory data and archiving for Biosimilars. * In close collaboration with stakeholders, support strategies to implement technologies and data governance supporting all current and future authorities’ requirements and ensures consistency of standards in systems and processes across relevant global company and Biosimilar functions. * Verify that resource and timelines assigned to project are in line with function capabilities. * On occasions participate in the implementation of Regulatory IT projects. * Follow-up costs to help control the best use of the budget of the Regulatory Information and Document Management activities for Biosimilars. * Be trained on requested SOPs and IT systems * Clean and format documents to make them eSubmission ready. * Train the organization on critical processes and techniques. Other Tasks: * Follow-up and self-train on new guidance, standards developments and technologies. * Coordinate and be accountable for planning, tracking and on-time production of Biosimilars dossiers. * Under supervision Support submissions up to their dispatch with a goal of no rework needed. * Manage process for creation and update of Submission Compilation Plan (SCP) including collection of resources and timelines constraints for small submissions * Support the Biosimilar Data Governance to ensure data protection and consistency of key data and metadata across systems for Regulatory processes COOPERATION * Create and maintain strong collaboration with cross-functional project teams * Support and promote the finalization of operational tasks when required for the best of the projects * Ensure that user support is provided within and outside of Regulatory Affairs, as appropriate. * Support submission team members in getting fluent in the use of agreed process or tools/systems. Qualification profile: Education: * Project Management * Technology * Health Sciences Job Specific Competencies & Skills: * Excellent organizational skills, work independently, self-motivated and proactive * Autonomous, goal-oriented and pragmatic * Strong customer-orientation and communication skills * Excellent analytical and problem-solving skills, Detail Oriented Languages: * Fluent command of spoken and written English, French is a plus Salary: * No university paper : 18' CHF / year (13th month included) * Bachelor degree : 30' CHF / year (13th month included) : - After 12 months salary increase to - 48' CHF / year (13th month included) * Master degree 42' CHF / year (13th month included) : After 12 months salary increase to 5’ CHF - If PhD degree obtained increase to 5’ CHF * Master/PhD + limited work experience : 60' CHF / year (13th month included) Benefits : * Fairmove/Transportation allowance: CHF/month and up to CHF (upon proof) * Swibeco/Meal allowance: CHF/month (%) * 20 days annual leave / 40 hours/week Apply now Share this job Print this Page Your contact Elisa E.Arnaud (On Leave) Fresenius Kabi SwissBioSim GmbH Eysins Kennziffer R- At a glance Job category: Engineering & Science Working condition: Full-time Business segment: Fresenius Kabi SwissBioSim GmbH Location: Eysins / International Closing date for application: none – We are looking forward to your application More information Information about the application process Our offer at a glance Fresenius Kabi is a global healthcare company that specializes in lifesaving medicines and technologies for infusion, transfusion and clinical nutrition. Our products and services are used to help care for critically and chronically ill patients. We seek talents and perspectives At Fresenius, we are convinced that combining different perspectives, opinions, experiences, cultures and values enables us to harness the potential that will make us even more successful. All job applicants are welcome. All terms used in this job advertisement to denote persons refer to all genders equally. #careerswithapurpose at Fresenius Over, people across the globe work at Fresenius to provide better ever medicine for ever more people. Our independent business segments Fresenius Medical Care, Fresenius Kabi, Fresenius Helios and Fresenius Vamed offer a wide spectrum of products and services in the health sector. We offer you the opportunity to make a difference with your career – and to become part of our impressive growth story.