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| 글로벌 헬스케어사 RA Specialist 경력직 채용(정규직) | |
|---|---|
| 회사소개 | 글로벌 헬스케어 기업 |
| 업무내용 / 자격요건 |
[담당업무] - Maintains the product license by applying RA activities and ensures compliance with local law, regulations, guidelines by monitoring and comply with internal standard operating procedures. - 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. - 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. - Support for reporting adverse events. - Performs other related duties as assigned. [자격요건] [QUALIFICATIONS] - Education : Bachelor’s degree major in Biochemistry, Pharmacy and/or Biological or Life science area at least. - Language : English business level. - Experience : Over 7 years’ experience in Regulatory affairs for pharmaceutical products. MNC working experience over 3 years. [COMPETENCIES] - Good command of spoken and written English. - Proficient communication skills with internal team, external partner and Health Authority (MFDS) on matters to be negotiated if necessary. - Passion for 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 and policies that require compliance. - Excellent analytical, problem-solving, and strategic planning skills - Proficient with MS office Suite and Hangul. - Good team player. [전형절차] 서류전형 - 컨설턴트 인터뷰 - 기업 면접 [제출서류] 국영문이력서(경력기술서 포함) [직무분야] RA [경력년수] 7년 이상 [기본연봉] 면접 후 협의 [참고사항] 정규직 포지션입니다. [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 |
| 담당자 |
담당컨설턴트: 박주연 컨설턴트 연락처: 02-782-9409 / 이메일: ap@cnscout.co.kr |
