▣ 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.
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: