외자 CRO사-RA업무
본문
Senior Regulatory Specialist / Regulatory Specialist
About the role:
Developing regulatory and project related documentation as required
Maintaining a current knowledge of applicable clinical trials related regulatory information for South Korea
Ensuring updates to clinical trials related regulatory processes for South Korea are shared with stakeholders in a timely manner
Supporting development and maintenance of clinical trials related regulatory SOPs, WIs and ADs for South Korea
Supporting internal training on clinical trials related regulatory processes for South Korea
Liaising with Study Team, Sponsor and Investigators as applicable to prepare clinical trials related documents for submission to regulatory authorities
Acting as local regulatory representative for any submissions to or request from the regulatory authority of South Korea
Collating, tracking and reviewing regulatory documents and packages according to project and South Korea requirements and timelines
Providing project specific updates and metrics relating to local regulatory submission status as required by project team
Providing regulatory support for project related activities such as country level feasibilities, observational studies, background research activities for proposals
Liaising with regulatory services vendors, if applicable.
About you:
Tertiary qualifications in a related science or health care discipline
At least 4 years' experience in CRO managing clinical trials related regulatory document preparation and submission
Strong knowledge of ICH-GCP guidelines, global and local ethical and regulatory requirements
High proficiency in English and Korean
Strong written and verbal communication skills including sound presentation skills
Ability to work in small teams and with a wide range of varying stakeholders
Excellent technological proficiency in Microsoft Office packages
Demonstrated flexibility and adaptable in the face of changing organisational priorities and ambiguous environments
We are searching for individuals who are results oriented and able to handle rapidly changing priorities in a fast-moving environment.
You must be willing to extend yourself and take on new challenges while living our values of Mutuality, Integrity, Can-do approach, Empowerment and Excellence.
About the role:
Developing regulatory and project related documentation as required
Maintaining a current knowledge of applicable clinical trials related regulatory information for South Korea
Ensuring updates to clinical trials related regulatory processes for South Korea are shared with stakeholders in a timely manner
Supporting development and maintenance of clinical trials related regulatory SOPs, WIs and ADs for South Korea
Supporting internal training on clinical trials related regulatory processes for South Korea
Liaising with Study Team, Sponsor and Investigators as applicable to prepare clinical trials related documents for submission to regulatory authorities
Acting as local regulatory representative for any submissions to or request from the regulatory authority of South Korea
Collating, tracking and reviewing regulatory documents and packages according to project and South Korea requirements and timelines
Providing project specific updates and metrics relating to local regulatory submission status as required by project team
Providing regulatory support for project related activities such as country level feasibilities, observational studies, background research activities for proposals
Liaising with regulatory services vendors, if applicable.
About you:
Tertiary qualifications in a related science or health care discipline
At least 4 years' experience in CRO managing clinical trials related regulatory document preparation and submission
Strong knowledge of ICH-GCP guidelines, global and local ethical and regulatory requirements
High proficiency in English and Korean
Strong written and verbal communication skills including sound presentation skills
Ability to work in small teams and with a wide range of varying stakeholders
Excellent technological proficiency in Microsoft Office packages
Demonstrated flexibility and adaptable in the face of changing organisational priorities and ambiguous environments
We are searching for individuals who are results oriented and able to handle rapidly changing priorities in a fast-moving environment.
You must be willing to extend yourself and take on new challenges while living our values of Mutuality, Integrity, Can-do approach, Empowerment and Excellence.
