PAs a Regulatory Specialist you will be expected to assist in regulatory submissions of clinical trial applications and support Clinical Research Associate activities at the study start and perform other administrative duties as assigned by management. We are searching for a positive and energetic person, eager to learn, push forward administrative processing of the documents and function well in the project team. Reporting to Regulatory Manager, you will be a key member of the Regulatory Affairs department in France or Italy. The suitable candidate shall have desire to develop in Regulatory activities and specialize with the time in Regulatory submissions and requirements for France/Italy. /ph3Minimum Qualifications Experience: /h3olliExcellent written and oral communication skills in English and French/Italian /liliFlexibility, adjustability, initiativeness /liliOpen to learn new things and communicate across countries and cultures /liliIndependence in work /liliPrevious experience in clinical research field is an advantage /liliBackground of natural science is an advantage /liliPosition is highly suitable for Study Coordinators /li /olh3Job Responsibilities: /h3olliParticipates in all activities leading to investigational sites activation /liliProvides interpretative assistance of guidance documents and regulatory rules applicable for France/Italy and ensures their communication through company policies and procedures /liliCustomize Patient Information Sheet and Informed Consent Form at country level /liliPrepares submission packages in cooperation with global team and upload document to CTIS for Part II /liliTakes part in the communication with Regulatory Authorities and Ethics Committees /liliProvides training and support to CRAs in order to collect all necessary documents for start up package and IP release /liliClose collaboration with Regulatory Lead and Project Team during entire project /liliPerforms tasks according to relevant SOPs and completes the SOPs training in given timelines /li /olpNovotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect. /ppOur team members are passionate about what we do, but we understand work is only one of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs.br/We are looking for people who are passionate about working in clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities. /ppWe are a Circle Back Initiative Employer and commit to respond to every application. We look forward to contacting you regarding your application. /ph3About Us /h3pbNovotech is a global full-service clinical Contract Research Organization (CRO). /b /ppHeadquartered in Sydney, Australia, Novotech has 34 offices across bAsia-Pacific /b, bNorth America /b, and bEurope /b. Novotech employs over 3000 employees and has over 5000 site partnerships and the resources and infrastructure to scale regionally and globally as clinical programs advance. /ppNovotech provides clinical development services across all clinical trial phases and therapeutic areas including feasibility assessments, ethics committee and regulatory submissions, data management, statistical analysis, medical monitoring, safety solutions, central lab services, report write-up to ICH requirements, project and vendor management. Novotech obtained the ISO 27001 certification which is the best-known standard in the ISO family providing requirements for an Information Security Management System. Together with the ISO 9001 Quality Management system, Novotech aims at the highest IT security and quality standards for patients and biotechnology companies. /p #J-18808-Ljbffr