1.Managing department
-Leading staffs to build teamwork within and inter departments to make them perform
their jobs related to registrations, variations, QA, promotional and advertising material
review etc.
-Developing policies and SOPs in the department and inspiring the implementation.
2. Regulatory affairs:
-Managing regulatory projects of healthcare product and business licenses, IND
approvals or other registrations:
-Approving the regulatory documents, approved licenses and related documents and
checking systematic filing of them
-Approving labeling provided from QA in line with product licenses
-Supervising RA guidance for QA, medical and market access activities and reviewing
documents if needed.
-Providing Management and corporate office/principal with monthly regulatory report
with project status
-Providing corporate office/principals with annual regulatory report
-Updating regulatory changes and estimating impact on the company
-Establishing regulatory strategy for the regulatory changes
3. Quality Assurance
-Managing QA activities for all category of healthcare products
-Managing the arrangement of overseas GMP inspection by KFDA with RA
4.BD
- Regulatory, pricing and market review of estimated local and corporate BD projects,
not limited to regulatory service projects
- Proposals for new regulatory projects
5. Leadership team
- Developing company strategy and making important decisions of matters for
company development
경력 및 자격요건
- Bachelor degree in Pharmacy or other related majors
- Minimum 10 years in regulatory & medical experience in pharmaceutical industries
- Proficient in oral & written English
- Strong leadership qualities and proven inter-personal skills
기타
- 원서 마감후 1차(서류) 합격자에 한하여 개별연락
- 이력서에 연락처, 희망연봉 게재
- 해외여행에 결격 사유가 없는 자
담당업무
입사지원
돌아가기
02-6281-5015
yhw@nterway.com
