Regulatory Affairs Specialist

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 , 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. 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 / Local Regulatory ConsultantLocation : DenmarkExperience : 5+ years in Medicinal Products Regulatory Affairs with experience in Life Cycle ManagementReporting To: Regional Regulatory Lead Role Type: Individual ContributorPosition Summary:The Local Regulatory Consultant – Denmark is responsible for the hands-on execution of regulatory submissions and lifecycle management activities across high-compliance, digitally mature Western and Northern European markets. This role focuses on ensuring precision in documentation, seamless system navigation, and proactive engagement with the Danish Health Authority (DKMA). Operating within a structured and digitally enabled regulatory environment, the consultant will contribute to ensuring timely submissions, compliance adherence, and robust regulatory readiness.Responsibilities:Prepare and submit Centralized (CP), Decentralized (DCP), Mutual Recognition (MRP), and national applications, including initial marketing authorizations, renewals, variations, and notifications in accordance with local requirements.Compile and validate Module 1 documentation, incorporating country-specific Blue Box elements, declarations, translations, and packaging artwork.Adapt and localize Product Information (PI) in compliance with EU QRD templates and DKMA expectations for labeling, SmPCs, PILs, and mock-ups.Ensure multilingual packaging compliance, with a focus on Danish and English, maintaining alignment with local and regional labeling strategies.Submit applications electronically via CESP, maintain product and submission data in XEVMPD, and manage procedural tracking using RIMS and related digital platforms.Monitor submission progress, respond to HA queries, track CHMP outcomes, and ensure timely implementation of feedback and renewals.Ensure audit readiness through meticulous document archiving, version control, and adherence to EMA and DKMA regulatory record-keeping standards.Collaborate closely with cross-functional teams, particularly market access, to support pricing and reimbursement submissions in line with local processes.Align with Nordic labeling harmonization initiatives where applicable, supporting consistent packaging and PI content across Denmark, Sweden, and Norway.Technical & Functional Skills:Proficiency in CESP, EMA IRIS, XEVMPD, and eCTD publishing tools, aligned with EU and DKMA submission formats.Demonstrated experience with DKMA procedures, including national regulatory requirements, lifecycle submissions, and HA correspondence.In-depth understanding of EU regulatory frameworks, including centralized, decentralized, and mutual recognition procedures.Expertise in multilingual packaging management, especially Danish and English, including local adaptation and Blue Box compliance.Practical experience in applying EU QRD templates for PI localization and approval.Familiarity with Nordic labeling harmonization practices across the Scandinavian region.Experience supporting pricing and reimbursement dossiers, with understanding of DKMA’s role in health technology assessments and market access approvals.Competence in using RIMS and related systems to manage regulatory timelines, document control, and submission lifecycle tracking.Proven ability to support regulatory audits and inspection readiness through accurate documentation, archiving, and regulatory intelligence.