Manager, CMC Regulatory Affairs, International

Working at Horizon is more than a job - it''s personal. For us, success is measured by the numbers that matter most - the number of lives we touch, the number we change and those we work tirelessly to help save. We''re a team of agile, out-of-the-box thinkers who are inspired to do more because we know we''re a part of something bigger. We strive to build meaningful careers at a company whose values we share because when we live up to our potential, we help others live up to theirs. Position Summary: As a Manager in Regulatory Affairs-CMC, you will play an important role in collaborating with technical, quality, regulatory and international teams to build core dossiers and relevant marketing authorization application packages for international markets. This position liaises with cross functional colleagues while representing Regulatory-CMC function to support the submission of Module 1, 2 and 3 requirements for marketing authorization applications. Responsibilities:Co-authors/authors/edits scientific content for CTD Quality sections aligned with regulatory strategy for clinical, commercial, and life-cycle CMC regulatory submissions and responses to health authority questions based on high quality technical reportsBuilds core dossier based on reference country Marketing Application for International marketsProvides scientific input for content generation for Quality modules 2 and 3Must possess a thorough ability to summarize data from source documents into Quality Modules 2 and 3 Reviews and adjudicates comments, facilitates comment resolution, revises draft sections. Ensures content clarity/consistency in messaging across dossierCoordinates with CMC matrix team members (such as regulatory, manufacturing, development, QA and PM) to ensure timely submissionsSupports the logistical process and detailed timeline for scientific/regulatory content creation for clinical, commercial, and life-cycle CMC-specific regulatory submissions and responses to health authority questionsSupports dossier creation and system compliance for regulatory submissionsAttends product specific subteam meetings, international subteam meetings to represent the regulatory CMC viewpoints and requirements for international marketsDevelops and maintains current CMC regulatory knowledge in countries/regions of interest and advises management of significant developmentWorks across functions to ensure Module 1 regional documents preparations are conducted, as neededAbility to travel - potential to be international as requiredQualifications and Skills Required:BSc/BA Chemistry, Biochemistry, Biology, or Pharmaceutical ScienceHands on experience (4 years plus) in a global CMC regulatory affairs position or in a technical functional and has previously authored Module 2 and 3 documents from Phase 1 through commercial and post-approvalBiologics experience is a mustProficient using Regulatory Information/Quality Systems and managing eCTD submissionsPrior experience with filing of marketing applications, supplements, and variations for biologic products within timelines is required, global submission experience is desired. Experience in orphan drugs is desiredA good understanding of IND, CTA, BLA, NDA and MAA processesStrong knowledge of international GMP quality regulations, current industry practices, and experience with interpretation and application to development projects and marketed product regulatory issuesProficient in Microsoft OfficeProfessional, proactive demeanorStrong interpersonal skillsExcellent written and verbal communication skillsHorizon Core Values & Competencies: Growth Manages Ambiguity Strategic Mindset Demonstrates Self-awareness Cultivates Innovation Develops Talent Accountability Drives Results Ensures Accountability Decision Quality Transparency Courage Collaboration Instills Trust Horizon requires all U.S. employees to be fully vaccinated, as a condition of employment, with either Pfizer (fully approved by the U.S. Food and Drug Administration), Moderna or Johnson & Johnson (currently granted emergency-use authorization by the FDA). ''Fully vaccinated'' is defined as two weeks after your final dose of the Pfizer, Moderna, or Johnson & Johnson vaccine. Horizon will provide medical and religious accommodations as required by law. Horizon Therapeutics plc does not discriminate on the basis of race, color, religion, gender, sexual orientation, national origin, age, disability, veteran status, or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors. Any individual, who, because of a disability, needs accommodation or assistance in completing this application or at any time during the application process, should contact the Human Resources Department.

Created: 2025-10-04