PEOPLE Insight Partners 메인 네비게이션
채용정보
| 포지션명 | [외국계 제약] Regulatory Affair | ||
|---|---|---|---|
| 회사명 | 진행상태 | 진행중 | |
| 업종 | 제약 / 바이오 / 헬스케어 | 직무 | 연구.R&D / 의사.간호사.의료전문직 / 기타 전문직 |
| 1. Job Title: Regulatory Affair 2. Job Descriptions; [Regulatory Affairs ] - Product registration of medicinal products and medical devices and life cycle management of product licenses - Manage regulatory projects related to South Korea including regulatory maintenance - Monitor policy changes and responsible to escalate these to local and global management team once any significant impact caused by the policy changes are foreseen - Maintain local RA SOPs to meet BRACCO SOPs and local regulations. [Pharmacovigilance] * Managing - Set up and maintain documentation system of PV (pharmacovigilance) in BIK Office, make sure the system meets both local regulations and BRACCO SOPs, and keep it up-to-date in timely manner to reflect the changes of circumstances - Directly communicate with HQ to keep up-to-date all PV relevant contracts (between Bracco Diagnostics Inc. and Bracco Imaging Korea) related to South Korea and make sure that all contract parties comply with the contract requirements - Prepare and attend the internal GVP audit by CQM and follow up CAPAs - Submit relevant drug safety reports to the local health authority within timeline if these are required by the local regulations. [Clinical Study Management] - Local management of Investigator Initiated Studies including, proposal submission, and research agreement management - Operate local clinical studies performed in South Korea - Prepare and attend the audit whenever it is called for the studies performed in South Korea by local authorities. - Local CRO selection and management of their activities whenever required by project - Provide product information to the internal employees and external customers whenever requested according to the local and BRACCO SOP - Review promotional materials according to the local and BRACCO SOP [P&R specialist] - price and reimbursement 3. Job requirements 1) Bachelor's degree in Pharmacy ? 약사 우대 2) Fluent in English 3) Over 10 years’ experience in the pharmaceutical industry, including management of all different regulatory affairs processes 4. 면접과정 1) 서류전형 2) 1차 Bracco 한국지사장, 인사팀 전무 3) 2차 Global region 화상 인터뷰 4) 3차 Global headquarter 화상 인터뷰 |
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