Regulatory Affairs(RA) Manager(차장급)
- Company
- 외국계 다국적 제약회사(의료장비,제약)
- Position
- Regulatory Affairs(RA) Manager(차장급)
- Status
- CLOSE
[Job Description]
• Coordinate and Manage timely Regulatory Submissions between local Cook company<?xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" />
• Coordinate and Manage timely Regulatory Submissions between local Cook company<?xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" />
(or throughout the region) and Cook Manufacturers.
• Work with Cook manufacturers to provide strategy and multiple options for meeting
• Work with Cook manufacturers to provide strategy and multiple options for meeting
regulatory requirements (provide “can do” solutions, not “cannot do” roadblocks)
• Personally write and review Regulatory Submissions as needed
• Organize electronic database (electronic library) of Regulatory Documents and government notifications
• Personally write and review Regulatory Submissions as needed
• Organize electronic database (electronic library) of Regulatory Documents and government notifications
on GTW (Global Technical Warehouse)
• Create training documents to improve regulatory skills in Local office (or throughout the region)
• Create training documents to improve regulatory skills in Local office (or throughout the region)
and at Cook manufacturers
• Train employees to improve regulatory skills in local office or region and at Cook manufacturers,
• Train employees to improve regulatory skills in local office or region and at Cook manufacturers,
where applicable
• Negotiate with local authorities on behalf of Cook objectives
• Support reimbursement efforts for all submissions where applicable
• Represent Cook as a member of industry organizations
• Learn the Cook Group vision for each regulatory submission and become a trusted leader
• Negotiate with local authorities on behalf of Cook objectives
• Support reimbursement efforts for all submissions where applicable
• Represent Cook as a member of industry organizations
• Learn the Cook Group vision for each regulatory submission and become a trusted leader
in the organization
[Job Requirement]
Qualifications
• Degree in science, engineering
Skills
• Fluent in English, both spoken and written
• Experience working for International companies
• Experience in regulatory for medical device industry
• Experience in negotiating with regulatory authorities
• Interpersonal Skills
• Organizational Skills
• Familiarity with Windows XP (Word, Excel, Power Point, Outlook Exchange, Lotus Notes)
Requirements
• Availability and willingness to travel in country and overseas.
• Capability to participate in training in USA or other countries.
• Positive attitude
• Cooperation with other Cook Asia/Pacific staff
• Strong management ability
• Strong leadership ability
• Degree in science, engineering
Skills
• Fluent in English, both spoken and written
• Experience working for International companies
• Experience in regulatory for medical device industry
• Experience in negotiating with regulatory authorities
• Interpersonal Skills
• Organizational Skills
• Familiarity with Windows XP (Word, Excel, Power Point, Outlook Exchange, Lotus Notes)
Requirements
• Availability and willingness to travel in country and overseas.
• Capability to participate in training in USA or other countries.
• Positive attitude
• Cooperation with other Cook Asia/Pacific staff
• Strong management ability
• Strong leadership ability
[Additional Information]
커리어수준 : 관리자(5년이상)
-급여사항: 면접 후 협의
-고용형태: 경력 정규직
[전형방법]
-1차 서류전형 (국문/영문 이력서 제출, 희망연봉 기재)
*서류는 워드문서로 작성해 주세요.
-2차 면접전형
-2차 면접전형
담당자: 김진태 상무
eMail: jtkim@exdigm.com, jtkim08@paran.com
Mobile: 010-2678-9319
