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| 글로벌 헬스케어사 Senior Regulatory Affair manager 경력직 채용 (지원마감) | |
|---|---|
| 회사소개 | 글로벌 헬스케어 기업 |
| 업무내용 / 자격요건 |
[담당업무] OVERVIEW (SUMMARY) The Sr. Regulatory Affairs Manager is responsible for ensuring that regulatory strategies and regulatory activities are effectively executed to meet the business objectives and legal requirements in Korea. ROLES AND RESPONBILITIES ? Monitor the company’s RA activities and ensures compliance with applicable regulations and standard operating procedures of Regulatory and Quality Intelligence ? Serves as a liaison between regulatory bodies and operating divisions of the company ? Prepares and submits applications and reports to applicable regulatory agencies ? Responds to requests for information from regulatory bodies ? Involved in Regional RA projects and respond in timely manner on queries based on Local regulations ? Monitors regulatory affairs and the effect changes will have on company operations ? Develops and maintains professional relationships in federal, state, and local regulatory agencies ? Manage independently all RA works to support commercial business success and compliance to local regulations ? Co-works with QA, PV and even commercial teams on urgent regulatory compliance issues in timely manner ? All applicable regulations should be complied all time during working ? Communicate with all stakeholders on regulation plan and strategies and propose best resolution at the regulatory perspective to minimize any commercial impact if any urgent situation ? Performs other related duties as assigned KEY PERFORMANCE INDICATORS ? Financial KPI of Team OP Achievement ? Existing Business Support by managing Current Business ? Support for New Business ? Support for Regional Quality team [자격요건] QUALIFICATION ? Education : Bachelor’s degree major in Biochemistry, Pharmacy and/or Biological or Life science area at least ? Language : Fluent in English in written and verbal communication ? Technical : Must be computer literate, Proficient with MS office Suite and Hangul ? Experience : Over 10 years-experience in Regulatory affairs for health products (medicines, medical devices, IVD, Foods, Cosmetics, Quasi Drug) controlled by MFDS at least COMPETENCIES REQUIRED - MNC working experience over 10 years - Intercommunication skills with Competent Authority, MFDS on matters to be negotiate if necessary. - Passion on new business development and willingness on overcoming challenges - Extensive knowledge of applicable government regulations - Ability to inform and educate managers and department heads on regulations an policies that require compliance - Excellent analytical and problem-solving skills - Excellent strategic planning skills - Proficient with applicable databased and compliance software [전형절차] 서류전형 - 컨설턴트 인터뷰 - 기업 면접 [제출서류] 국문이력서(경력기술서 포함) [직무분야] RA [경력년수] 10년 이상 [기본연봉] 면접 후 협의 [참고사항] ? Employment type : Permanent [지원방법] 하단의 회원 온라인지원 혹은 ap@cnscout.co.kr 로 이력서를 보내 주시면 검토 후 헤드헌팅을 진행하여 드리겠습니다. |
| 기타사항 |
학력:대졸이상, 외국어:무관 직급/직책:면접 후 협의 근무지:서울 용산 |
| 담당자 |
담당컨설턴트: 박주연 컨설턴트 연락처: 02-782-9409 / 이메일: ap@cnscout.co.kr |
