Manager or Senior Manager, Regulatory Affairs, Korea - Seoul, Seoul
등록 회원 전용 Seoul, Seoul, 대한민국.
1개월 전
* 이 급여 범위는 beBee에서 추정한 것입니다.
Job summary
The Manager or Senior Manager, Regulatory Affairs will be responsible for managing investigational new drug application (IND) related regulatory works and drug registration process in timely and efficiently from beginning to end in accordance with regulatory requirements and coordinate regulatory activities between cross-functional teams.
Responsibilities
- Prepare, submit and support clinical trial applications and product registration.
- Obtain successful regulatory submission and approval of new products and be compliant and effective with all product safety activities in Korea
- Manage and oversee all relevant maintenance activities potentially including Life Cycle Management strategy with compliance with the relevant law and internal procedures.
- Collaborate and communicate effectively with teams internally and external bodies to meet business objectives.
Qualifications
- Minimum 7 years of work experiences in regulatory affairs and Minimum 9 years of experiences in pharmaceutical Industry in Korea
- Strong knowledge of current Korea regulations
- Computer Skills: Experience in working with MS office in a Windows environment
- Negotiating, communication and interpersonal skills
- Fluency in written and spoken English
직무설명서
Lorem ipsum dolor sit amet
, consectetur adipiscing elit. Nullam tempor vestibulum ex, eget consequat quam pellentesque vel. Etiam congue sed elit nec elementum. Morbi diam metus, rutrum id eleifend ac, porta in lectus. Sed scelerisque a augue et ornare.
Donec lacinia nisi nec odio ultricies imperdiet.
Morbi a dolor dignissim, tristique enim et, semper lacus. Morbi laoreet sollicitudin justo eget eleifend. Donec felis augue, accumsan in dapibus a, mattis sed ligula.
Vestibulum at aliquet erat. Curabitur rhoncus urna vitae quam suscipit
, at pulvinar turpis lacinia. Mauris magna sem, dignissim finibus fermentum ac, placerat at ex. Pellentesque aliquet, lorem pulvinar mollis ornare, orci turpis fermentum urna, non ullamcorper ligula enim a ante. Duis dolor est, consectetur ut sapien lacinia, tempor condimentum purus.
, consectetur adipiscing elit. Nullam tempor vestibulum ex, eget consequat quam pellentesque vel. Etiam congue sed elit nec elementum. Morbi diam metus, rutrum id eleifend ac, porta in lectus. Sed scelerisque a augue et ornare.
Donec lacinia nisi nec odio ultricies imperdiet.
Morbi a dolor dignissim, tristique enim et, semper lacus. Morbi laoreet sollicitudin justo eget eleifend. Donec felis augue, accumsan in dapibus a, mattis sed ligula.
Vestibulum at aliquet erat. Curabitur rhoncus urna vitae quam suscipit
, at pulvinar turpis lacinia. Mauris magna sem, dignissim finibus fermentum ac, placerat at ex. Pellentesque aliquet, lorem pulvinar mollis ornare, orci turpis fermentum urna, non ullamcorper ligula enim a ante. Duis dolor est, consectetur ut sapien lacinia, tempor condimentum purus.
전체 액세스 권한 얻기
모든 고위급 직책에 액세스하여 꿈에 그리던 직업을 얻으세요.