외자계-Sr. Regulatory Affairs Manager(국내RA업무)
페이지 정보
등록자 :
송흥용부사장
등록일 : 22-04-20 15:25
기본정보
외자계-Sr. Regulatory Affairs Manager(국내RA업무) | |||
개발 | 대리~차장 | ||
무관 | 무관 | ||
서류전형 -> 1차면접 -> 2차면접 | |||
2022-04-20 | 채용시 |
상세정보
본문Responsibilities
- Preparing the registration dossiers in eCTD format (INDs, NDA and DMF). - Developing the regulatory strategy of the registration of different products in South Korea. - Performing quality control checks for submission ready documents. - Participating in regulatory-clinical cross functional team meetings and project teams. - Preparing responses to MFDS queries as needed - Gathering and assembling information necessary for submissions in accordance with MFDS Regulations and relevant guidelines. - Developing timelines for submissions and tracking the regulatory deliverables. - Providing Regulatory Affairs support during internal and external audits. - Defining regulatory deliverables for each project and monitoring projects through completion - Assisting in the development of best practices for Regulatory Affairs processes. - Supporting GRP Clients in South Korea. - Reporting the regulatory activities to GRP CEO on regular basis Qualifications - Authorized Pharmacist in south Korea. - Bachelor degree in the Life Sciences or a related field, and self-starting ability with excellent written and verbal communication skills. - At least 6 to 8 years-experience working as Regulatory Affairs Manager in South Korea for pharmaceuticals or biotech company in South Korea. - Proficiency in MS Word, MS Excel, and Adobe Acrobat is essential. - Good understanding of the drugs registration process, - Has prepared and submitted at least 1 NDA and 1 IND to MFDS - Working knowledge of industry legislation and best practices - Good project management skills - Good communication in English and writing in English. - Document management, or equivalent technical experience. - Ability to work in a fast-paced environment that is primarily timeline-driven. - Ability to manipulate large and complex documents required for submissions. - Attention to detail with the ability to multi-task. *국문 이력서,경력기술서 및 영문이력서,경력기술서 병행 송부 |