Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.We believe that diversity adds value to our business, our teams and our culture. We are committed to equal employment opportunities that foster an inclusive environment.Help us lead one of the world's largest pharmaceutical companies. We are a world leader in plasma-derived medicines with a presence in more than 100 countries, and a growing global team of over 20.000 people. That's why we need a Regulatory Affairs Specialist like you.MissionExecute clinico-regulatory activities for programs under your responsibility which are under development and/or life cycle managementWhat your responsibilities will beUnder supervision of your manager, together with internal stakeholders, prepare regulatory dossiers, submit and follow-up procedural applications Clinical trial applications and related documents (IND, IMPD) in liaison with the Clinical Study Team and the CROOrphan drug designations and pediatric plans as applicablePerform a QC of development regulatory dossiers prepared by other specialists as neededProvide clinico-regulatory support for license extensions or variations for International Review dossiers when applicableRespond to queries raised by Competent AuthoritiesMaintain his/her regulatory knowledge of the regulation and of the environmentWho you areTo perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, education, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions).Bachelor's degree in Pharmacy or Scientific DegreeMinimum 2-year experience in Regulatory Affairs, ideally dealing with clinical trials, within the pharmaceutical industry or Clinical Research OrganizationsIdeally, experience with the EU Clinical Trial Regulation and the EU/EEA Clinical Trials Information System (CTIS)Good knowledge of GCPOrganized and prioritize tasksTask oriented, rigorous, with good communicationFacilitates information sharing and keeps supervisors updatedAbility to escalate any difficulties and to identify risksAdvanced English and SpanishWhat we offerIt's a brilliant opportunity for someone with the right talents.Grifols understands you want a challenging and rewarding career in a critical function Regulatory Affairs Specialist help you grow professionally.Information about Grifols is available at www.grifols.com. If you're interested in joining our company and you have what it takes, then don't hesitate to apply.We look forward to receiving your application.Grifols is an equal opportunity employer.Flexible schedule: Monday-Thursday 7-10 to 16-19h and Friday 8-15h.Benefits packageContract of Employment: Temporary positionFlexibility for U Program: 2 days remote working#J-18808-Ljbffr
