Specialist, Regulatory Affairs(육아휴직계약직) at Organon in Seoul

Job description

Job Description The Position The RA Specialist ensures timely regulatory approval and product license maintenance by developing effective registration strategies that align with local regulations and global compliance standards. They manage the submission process, maintain compliance with regulatory requirements, and support cross-functional teams by providing regulatory guidance. Additionally, the role involves evaluating safety information, managing regulatory operations, and ensuring efficient information management across the RA area to meet both local and global standards. Note 해당 포지션은 출산/육아휴직 대체 포지션으로 17개월(TBD) 근무 예정입니다. 단, 근무기간은 입사일에 따라 +,- 수개월 차이날 수 있습니다 Responsibilities For assigned products and under supervision of Country Lead/Director/Associate Director ensures timely preparation, submission and appropriate follow-up of Marketing Authorization applications to the local health authorities. For assigned products and under supervision of Country Lead/Director/Associate Director ensures maintenance of assigned, authorized products through timely submission of variations, renewal and RMP, pre-approval and post-approval HA GMP audit and supplemental marketing authorizations. For assigned products ensures high quality labelling translation and artwork management. Supports the agency interactions to ensure a seamless submission, assessment, and smooth approval. For assigned products and tasks, stays updated on relevant local regulations and guidelines. Monitor, review and assess local regulations and relevant information (regulatory intelligence)and inform the relevant stakeholders Maintains a positive relationship with internal and external regulatory contacts. Senior position may take on more advanced and independent responsibilities and act as supervisor regarding selected regulatory activities. New MA applications for assigned products: Under supervision, performs timely and accurate submissions and approvals of assigned new Marketing Authorization applications, in close cooperation with local and global stakeholders, as well as with local HA when applicable. Tracks the process of product registration and product launch process. Maintenance of licenses for assigned products: Under supervision, ensures that marketing authorizations are maintained in compliance with related regulatory areas, through performing the necessary activities, including variations, renewals and RMPs within the agreed timeframes and communicate approvals to stakeholders in compliance with corporate standard and local regulations. Compliance: For assigned products, ensures timely preparation and maintenance of local labeling, packaging material and other applicable regulatory documents according to company and local standards and relevant Artwork Management procedures. Ensures that all internal stakeholders receive relevant information with regard to the regulatory status of the assigned products. Ensures the correct and proper utilization of Artwork Management System to generate mock-up and commercial artwork and to implement revisions to artwork. Ensures efficient and consistent implementation and use of internal and external regulatory databases (e.g의약품안전나라) and systems (e.g internal RA systems) in the country. Ensures that files and archives related to Regulatory are kept updated and complete. Participates in establishing and maintaining of relevant Standard Operating Procedures every 3 years or when as necessary to secure that the current regulations are complied with. Implementation of updated regulatory documentations (including but not limited to CMC, S&E documents) according to Agency requirements and internal guidance. Evaluate the local impact of safety information based on global regulatory authorities(UPSI)or approved product information and report to the local HA as necessary Editing and labelling: In connection with the submission of MA applications and post-approval submissions, provide translation and QRD checks, and ensure qualit