Regulatory Affairs Associate

About the jobAbout FreyrFreyr is a fast-growing, innovative company specializing in providing end-to-end regulatory solutions and services for the Life Sciences industry. With a commitment to excellence and innovation, we assist pharmaceutical, medical device, and biotech companies in navigating the complexities of regulatory compliance.Why Freyr?At Freyr, we believe in fostering a collaborative and dynamic work environment that empowers our team to make a real impact. As we expand our footprint , we are on the lookout for passionate and skilled Regulatory professionals to join us in shaping the future of regulatory services.Join Our Team:If you're ready to embark on a journey of growth and innovation, connect with us to explore the exciting opportunities awaiting you at Freyr's new chapter in Warsaw, Poland. Together, we can shape the future of regulatory solutions.📢 To Apply:Please apply to this job post or you can visit our Careers page for more openingsVisit our Careers page at (https://www.freyrsolutions.com/careers/current-positions) to explore current job openings and submit your application.Don't miss this chance to be a part of Freyr's expansion and make your mark in the world of regulatory services. Let's redefine regulatory excellence together!Title : Regulatory Affairs Associate - Regulatory Operations.Location : Poland ( Base location should be Poland. No visa sponsorship)Description :Population of Content Plan template with specifics for submission and metadataManaging/owning workflows for regulatory-owned Module 1 documentsPreparation of Module 1 Administrative documentsConduct preliminary QC of submission output and release for submission, as requiredDraft & circulate to GRL for review and send Regulatory Notification email.Assists GRL with submission of Form FDA 1572 and new PI CV, if applicable, to the US IND.Conduct QC of eTMFUpdate Product Responsibility List (PRL) / Regulatory Project Team Assignments (RPTA)Provide support over MEDIVA activities -o Upload/Download documents to/from MEDIVAo Creation of Submission Record / Regulatory Objective / Submission Binder in MEDIVA\o MEDIVA Binder QCo Archival of CorrespondenceOther regulatory coordination and operational activities, as requested by RPM