채용공고
제목 Regulatory Affairs Associate (동물의약)
모집기간 2018-05-30 ~ 2018-07-23 상태 선별중
모집부서 Veterinary Affairs / Animal Health
업무개요

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









응시자격

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


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