Regulatory Affairs Specialist - Labeling

About 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 to Warsaw, Poland, we are on the lookout for passionate and skilled Regulatory professionals to join us in shaping the future of regulatory serviceJoin 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. 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 Specialist - LabelingLocation : Poland / Romania / Croatia / Hungary / Czech Republic / UKExperience : min 5+ years in Regulatory Affairs LabelingKey Responsibilities:Responsible for coordinating Labeling workflow activities and Labeling Change Controls support.Initiate and investigate labelling events/Quality Events, Corrective and Preventative Actions (CAPAs), Review, and close out Effectiveness checks (EC) and maintaining tracking logs for all the above.Liaise with cross-functional partners in Global Patient Safety Evaluation (GPSE), Local Operating Companies (LOCs), Global Quality, Global Manufacturing and Supply; and throughout Global Regulatory Affairs.Support inquiries/audits from third parties (e.g., Regulatory Authorities, legal, partners, etc.) regarding historical product labeling.Track and update RIM systems related to specific labelling events, e.g., uploading relevant documents, communication with relevant stakeholders, updating important dates in the systems, sending notifications to relevant stakeholders.Provide post approval support of CCDS changes and updates (e.g., changes to products, exceptions, deferrals etc.).Manage global labelling mailbox, triage, and forward emails to appropriate stakeholders and archiving emails to respective product folders.Labeling system support sessions for users (TRAIL and other Labeling systems).Manage Labelling folders on Freyr / Client systemsFoster a culture of labeling process excellence and regulatory integrity.Promote collaboration and cross-functional engagement across regions and functions.Skills Required:At least 8+ years of experience in Regulatory Labeling, with experience managing activities such as labelling changes including CCDS / CCSI update, review, LPD development, coordination with cross functional teams etc.Strong understanding of pharma labelling requirements and regulations.Experience with managing large delivery teams.Proficiency with Workflow management tools such as Trackwise, and other industry standard tools.Ability to work under deadlines and fast paced work environment.Ability to work independently with little or no supervision.Excellent business collaboration / interpersonal skillsComputer literacy required in Microsoft Office Products such as Word, Excel, and OutlookAttention to detail and strong project management skillsAbility to multitask and prioritize competing agendasGood organizational skills.