Regulatory Affairs Manager, Contrast Media  



[Your tasks & Responsibilities]

Korea Specific Tasks

    1. Leading contribution to operational activities within the team to assure diligent and professional regulatory checks and timely delivery of documentation, compliance support to R&D and other stakeholders on development activities and issue management.

    2. Continuously identifies and implements efficiency, productivity goals for integrated RA organization (resources, processes, systems).

    3. Works closely with regional and global regulatory to identify resource requirements within assigned geography and manages own resources to meet regulatory needs. Ensures early identification of conflicts between projects and ensures transparent and aligned prioritization in consultation with global regulatory and Head of Commercial Radiology. 

    4. Ensures preparation of the application files for products based in the documentation from RA regulatory partners in accordance with local regulation, is of acceptable standard and quality for the respective authorities. 

    5. Where applicable, ensures the preparation of the application files for clinical trials, based on the documentation provided from RA regulatory partners, are in accordance with the local regulations and presents them to the respective authorities, where locally relevant. 

    6. Work closely with Pharmacovigilance (PV) for PSUR and AE reporting as needed.

    7. Work closely with Quality to provide regulatory expert input to manage product complaints and recall process, including health authority interaction and communications. Provide necessary functional input and documents to enable Quality to complete local compliance checks and develop local QSD process.

APAC Specific Tasks




[Qualifications / Requirement]




 “신체적 조건과 출신 지역, 혼인여부, 재산, 구직자 직계존비속 및 형제자매의 학력, 직원, 재산과 관련된 정보는 지원서류에 포함하지 마십시오. 단, 바이엘코리아에 재직 중인 가족이 있을 경우, 회사가 공정한 채용을 위한 조치를 취할 수 있도록 입사지원서를 통해 사전에 고지해 주시기 바랍니다.”