Regulatory Affairs Associate (or Specialist)

Regulatory Affairs Associate (or Specialist)

[지원기간] ​ 2019-09-04 ~ 2019-09-18

[근무부서] Veterinary Affairs / Animal Health

[직무내용]

1. Product registration : Manage the product registration
  • Prepare dossier, Submit dossier, and Achieve Registration for New, Label extension and aligned with project timeline
  • Contact to national authorities for Registration & other related matters to ensure full compliance of local law & regulation. Monitor/Update related regulatory guidelines

2. Study Management : Coordinate the product development trial with external parties (research center, association & university) to achieve business objectives within timeline to comply with Bayer and local regulation

3. Monitor routinely the regulatory environment and to implement in a timely manner or spread out to the responsible department if necessary

4. Review product labeling and packing material in compliance with local regulation and approve it

5. Support Head of Veterinary Affairs to achieve the medical and regulatory strategic objectives as a team member

6. PV Case Management : Handles all matters regarding AE/PTC handling
  • Responsible for data entry from all reporting sources in the PHARAO
  • Liaises with the Local Quality Representative (LQR) in relation to AE reports associated with Product Technical Complaint (PTC) and aligns on actions
  • Responsible for case receipt and transfer to PHARAO. Identifies cases where missing or unclear information is provided and performs clarification as needed with reporter
  • Performs follow-up activities in a timely manner
  • Responsible for reconciliation of cases with internal functions and external partners

7. PV Process Management : Executes a high-quality oversight of local PV process and compliance management
  • Monitor local PV regulation and Bayer quality system document management
  • involved in the preparation of the PV training given to the local organization (schedule, training material, organization)
  • Conducts the local literature search for AEs as well as the routine testing of PV systems

8. Safety Management : Supports handling of local safety topics and issues and contributes to appropriate use of Bayer’s products

[자격요건]

1. Background: Bachelor degree or above, major in veterinary medicine, pharmacy or life science

2. Experience: minimum 1-2 years of Regulatory Affairs experience in pharmaceutical company (or maximum about 5-7 years)

3. Skills
- Profound knowledge of regulations and its requirements
- Executive ability to produce highly qualified applications
- Good communication and negotiation skills
- Good command of English communication skills
- Good understanding of veterinary / pharmaceutical science

아래 사이트에서 크롭사이언스 환경과학사업부에 대해 확인하세요
http://www.es.bayer.co.kr            

[근무조건]

근무형태: 정규직

근무요일/시간: 주 5일(월~금), 오전 8시30분 ~ 오후 5시 30분
근무지역: 서울 동작구

급여: 회사내규에 따름

[안내사항: 전형, 제출서류, 접수방법]

 전형방법

   - 1차 서류전형, 2차 면접전형

 제출서류

   - 국문/영문 이력서, 자기소개서 (각종 증빙서류는 면접전형 합격자에 한해 추후제출)
지원방법

   - www.bayer.co.kr 로 접속하여 인재채용 – 채용공고 란에서 온라인 지원
     (국문이력 및 자기소개서는 온라인 지원시 작성, 영문 이력서는 워드파일로 작성하여 온라인 지원시 파일첨부)

[문의사항]

 전화: 02 - 829 - 6872

 주소: (156-010) 서울 동작구 신대방동 395-62 삼성보라매옴니타워

[기타 안내사항]

 - 면접은 서류전형 합격자에 한해 개별통지 합니다
 - 국가보훈대상자와 신체장애자는 관련서류 제출시 관계법에 따라 우대합니다
 - 남자는 병역필 또는 면제자로 해외출장에 결격사유가 없는 자를 모집합니다
 - 모든 서류는 반드시 MS Word로 작성하기 바랍니다.
 - 제출하신 서류는 일체 반환하지 않습니다.
 - 입사지원서 내용에 허위사실이 판명될 경우 입사가 취소될 수 있습니다.

 - 신체적 조건과 출신 지역, 혼인 여부, 재산, 구직자 직계존비속 및 형제자매의 학력, 직업, 재산과 관련된 정보는 지원서류에 포함하지 마십시오.