[담당업무]

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

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

[근무부서 및 직급/직책]

근무부서: RA, 학술개발부
직급/직책: 사업부장

[자격요건]

경력: 경력 10년↑
학력: 대졸 이상
직무기술: 약사
기타: 외국계 제약업체 근무 유경험자 우대

[우대사항]

외국어: 영어 회화능통,독해능통,작문능통
자격증: 약사
우대사항: 해외여행에 결격사유가 없는자