담당업무

< Primary Function >

As an individual contributor, the function of a Regulatory Affairs Manager is to provide support for the regulatory department to ensure efficient and compliant business processes and environment. The individual may execute tasks and play a consultative role by partnering across business functions. The

individual may assist in identifying data needed, obtaining these data and ensuring that they are effectively presented for the registration of products worldwide. The individual may prepare and submit documentation needed for registration worldwide or may oversee such preparation.

<Major Responsibilities > 

Regulatory Knowledge/Skills

- Interpret and apply regulatory requirements

- Compile, prepare, review and submit regulatory submissions to authorities

- Regulatory history, guidelines, policies, standards, practices, requirements and precedents

- Regulatory agency structure, processes and key personnel

- Principles and requirements of applicable product laws

- Submission/registration types and requirements

- Principles and requirements of promotion, advertising and labeling

- Domestic and international regulatory guidelines, policies and regulations

자격요건

Qualifications/Experience:

.대졸이상 / 관련전공자 선호 ( 과학, 수학, 공학, 의료 ) 

.의료분야 10년이상 검증된 경력 

.Communication 능력, 분석/비판적 사고능력, 다양한 대안제시 , 관련분야 폭 넓은 지식 보유

.Define regulatory strategy with supervision

.리더쉽 보유

.영어 상급