We are seeking a Regulatory Management Specialist responsible for supporting our export and import regulatory & compliance matters from a pharmaceutical/in-vitro diagnostic perspective. This position will collaborate with Global Regulatory and management stakeholders on various international regulatory compliance projects. The role will support our Life Science business to fully comply with all relevant customs and other government agency requirements. Responsibilities include implementing effective control procedures for the import/export of regulated items and providing direction on regulations. Provide regulatory support for pharmaceutical life cycle management to customers purchasing Life Science products (ex. DMF registration, new drug application). Manage regulatory pathways for Life Science products and services in South Korea, covering areas like aseptic processing, raw materials, single-use systems, active Pharmaceutical Ingredients (APIs)/excipients, food additives, medical devices/IVDs, and novel modalities. New product review: Review and classify products against regulatory requirements from a pharmaceutical/in-vitro diagnostic perspective. Provide policy direction, guidance, and support for import/export activities to Commercial, Customer Excellence, Supply Chain, and Distribution, especially related to API, excipient, MD/IVD, and raw materials used in biopharma/pharma and IVD manufacturing processes. Interface with customs authorities and customs brokers to ensure regulatory compliance for import and export shipments from a pharma/IVD perspective. Provide regulatory support to marketing, sales, and customers through seminars and training events, collaborating with subject matter experts. Monitor changes in regulatory environments, provide regulatory intelligence to regional/global experts, assess impacts, and establish mitigation strategies to prevent supply disruptions. Advocate for pharma industrial unmet needs and provide feedback on proposed regulations to regulatory authorities. Coordinate strategic activities with subject matter experts, local regulatory bodies, and industry associations. Implement the company's regulatory management policy, corporate standards, and best practice procedures. Who You Are: Education and Languages: Bachelor’s degree in life sciences or related science background with a strong emphasis on biopharmaceuticals/biologics/chemical (Master’s degree preferred). Fluent in Korean and English (verbal and written). Professional Skills and Experience: Minimum of 7 years’ experience in the pharmaceutical industry (RA or QA from local pharma manufacturers preferred). Comprehensive knowledge/experience of local/global pharma regulation, especially from a quality/GMP perspective. Personal Skills and Competencies: Team player with excellent analytical, organizational, and problem-solving skills. Strong interpersonal, presentation, and communication skills. Proficient in managing multiple priorities and delivering accurate outcomes. Ability to analyze and respond to situations quickly and effectively. Proficient in MS Office Software (Word, Excel, Power Point, Project). Capable of working well in a collaborative, cross-functional team environment. Ability to handle multiple assignments simultaneously to meet priorities and deadlines. Ability to indirectly influence other organizations and cultures. <유의사항>•여러분이 찾고 계시는 채용 포지션이 없으신가요? 그렇다면 인재풀(클릭)에 여러분의 이력서를 등록해주세요! 향후 인력 수요가 있을 경우 최우선으로 안내드리겠습니다.•지원 순으로 전형이 진행되며, 적합한 후보자 발견 시 채용이 바로 마감되오니 지원의사가 있으신 분들은 빠른 지원 바랍니다.•서버 안정성을 위해, 인터넷 익스플로러가 아닌 구글크롬, 혹은 마이크로소프트 엣지를 통한 지원 바랍니다.•보훈대상자 및 취업보호대상자는 관련법에 의거하여 우대합니다.•지원서의 기재사항이 사실과 다른 것으로 확인되거나 Reference from previous employer 상에 채용상의 결격사유가 확인될 경우 합격 또는 채용이 취소될 수 있습니다.•(The company reserves the right to withdraw the offer, it if discovers subsequently that a candidate has given false information in application or has provided false or fraudulent documentation in support of his/her application. The offer is conditional upon satisfactory results of reference checks.)•"머크 코리아 채용" 카카오톡 페이지와 친구를 맺어 최신 채용 소식을 받아보세요! (카카오톡에 '머크 코리아 채용'검색 후 친구추가)