Senior Regulatory Affairs Associate or Regulatory Affairs Lead

(경력 5년 이상 시니어)

[담당업무]

- Provide regulatory consultation and strategy planning for clinical trials, product registration/variations/renewals of

  medicinal products, medical devices and/or biologics as required

- Compile regulatory documents for submission to regional regulatory authorities according to local requirements

- Develop and execute regulatory plans for clinical trials, product registration/variations/renewals of medicinal products,

  medical devices and/or biologics as required

- Assess appropriateness of existing documentation and provide gap analysis and support of the documentation for

  an application/ approval in the target countries

- Review, edit and proofread regulatory documentation as applicable, to ensure good quality standard documents

  for regulatory submission

- Participate as an active team member of local/regional project teams as required. Responsible as functional leader,

  to work collaboratively with other operational project team(s) to ensure seamless cross-functional communication/documentation

  and that the project related activities are conducted in the highest quality standards,

  in compliance with international guidelines and applicable local regulatory requirements as well as to meet/exceed sponsor’s expectation

[지원자격]

- Over 5 years direct experience in regulatory related work for clinical trials and registration of medicinal/ device/ biologic products

- Effective written and verbal communication skills, preferably with good command of English in addition to local language

- Preferred: Multiple experiences in regulatory consultation projects