JOB OPENING
채용정보 검색
Regulatory Affairs Associate
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2014-12-18  |
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|---|---|---|---|
| · 포지션 | |
| 회사소개 | 글로벌제약사 |
| 직급/직책 | 사원,대리급 |
| 담당업무 | [Purpose of Job] The Regulatory Affairs Associate is responsible for assisting in timely and efficiently managing drug registration process from beginning to end in accordance with regulatory requirements. [KEY Accountabilities and Responsibilities] - Assists in obtaining marketing approval from the KFDA for a planned new drug(K-NDA) and ensures subsequent maintenance of drugs registered (Supplemental & Amended K-NDA). - Contributes to the effective and efficient initiation of clinical trials with the company's investigational new drug through supporting for K-IND submission and approval. - Ensures registered products are maintained and updated in full compliance with all relevant legislation and SOPs. - Provides regulatory affairs related information to other departments. - Assists Regulatory Affairs Manager to establish, develop and maintain close working relationships with the relevant regulatory authorities and associations (KFDA, MOHW, KJPA etc.) - Assists Regulatory Affairs Manager for coordinating regulatory activities among departments (Marketing, Business Development etc.) and timely communications with TGRD, TPC and Millenium. - Assisits Regulatory Affairs Manager to develop new product registration strategy. (Essential responsibilities : 1. Registration feasibility pre-review 2. Preparation of K-NDA or K-IND files 3. DMF and/or GMP site inspection 4. Maintenance and update of registered products 5. Product label management 6. Interactions with TGRD 7. Other duties as assigned |
| 근무지 | 서울 강남 |
| 처우조건 | |
| · 자격요건 | |
| 학력 | 대졸 이상 |
| 경력 | - 2+ years experience in pharmaceuticals with at least 2 years in RA - Must be degree qualified, pharmacy - Proven ability to build and maintain relations with internal as well as external customers - Good project management skills and effective communication skills |
| 연령 | 30세 전후 선호 |
| 특기사항 | |
| · 접수방법 | |
| 마감일 | 마감 |
|---|---|
| 전형절차 | 서류전형/면접 |
| 제출서류 | 국문이력서(구체적인 경력기술 포함) |
