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Regulatory Affairs & QA Manager- 미국계제약회사 (

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외국계 제약회사 외국계기업 261명

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모집부문 Regulatory Affairs & QA Manager- 미국계제약회사
업무내용 Regulatory Affairs & QA Manager- 미국계제약회사

Job Title : RA & QA Manager - 미국계 제약회사


Job Function : Regulatory Affairs and Quality Assurance


JOB PURPOSE AND SCOPE

– describe in 3-4 short sentences the responsibility and authority (budget, revenue, internal/external contacts, etc.) of the job.

This position leads RA & QA to support sustainable business growth.

Responsible for regulatory projects and compliance activities for responsible country. Develops and implements strategies for earliest possible new product launching.

Accomplishes results individually and through subordinates. Frequent contacts with internal and external personnel concerning operations or scheduling of specific phases of projects. Conducts briefings and participates in technical meetings for internal and external representatives concerning RA & QA.


CORE JOB RESPONSIBILITIES
– list the primary tasks or activities this job performs on an ongoing basis.
- Develops strategy and leads RA and QA projects to support sustainable business growth.
- Manages activities associated with pre-market approval and quality assurance of current and pipeline
- Collaborate with counterpart local and HQ to support local planning in accordance with national regulatory requirements aligned with global plan.
- Monitors project progress, auditing and self-assessment activities under the compliance framework.
- Monitors changes in egulatory environment trend, threats, opportunities
- Company representative for RA and QA for agencies and industry groups.
- Plan and drive to work towards achieving RA & QA target aligned with company vision, objectives as well as divisional mission and strategies.
- Timely communication of local regulatory requirements or changes to stakeholders.
- Coaches and advises juniors.


SUPERVISORY/MANAGEMENT RESPONSIBILITIES (if applicable)
– define the size of the organization this job is responsible for as well as the level of the positions reporting into this job.

- RA Associate/Specialist/Sr.Specialist
- QA Associate/Specialist/Sr.Specialist


MINIMUM SKILLS REQUIRED

– identify the specific skills needed to perform this job effectively (leadership skills, selling skills, computer literacy, etc.)

- Experience in regulatory affairs and compliance and knowledge of regulations applicable to the business
- Understanding of the relationship of commercial ops to regulatory/compliance
- Capable to build relationship with Competent Authority
- Good level of responsiveness to need of commercial organization
- Ability to prioritize and resource regulatory activity according to business needs
- Ability to work in international environment and willingness to travel
- Good spoken and written of English and local language
- Experience in coaching.
- Ability to understand and communicate regulatory, scientific, and clinical information.
- Ability for problem solving and to develop a course of action leading to beneficial outcome.
- Business acumen in regulatory environment changes.
- Good interpersonal networking with internal & external stakeholders.

KNOWLEDGE / EDUCATION REQUIRED
– identify the knowledge, expertise, educational level required to perform this job successfully (product /industry knowledge, technical /business acumen, university degree, professional certification, etc.)

- Knowledge in of regulatory affairs in medical device, healthcare business and/or environment, etc.
- Minimuim BS degree +
- Life Science, Medical Engineering, Medicine, Pharmacy, Nursing, etc. are preferred.



EXPERIENCE REQUIRED
– describe the on the job experience level required to perform this job (e.g. years of management experience, years of experience in a certain discipline, etc.).

- Bachelor Degree - 10+ years of relevant experience
- Master Degree - 8+ years of relevant experience
- 2+ yrs of people management.
- Experience gained in multinational medical device companies will be an advantage




서류접수E-mail : kschoi@hrkorea.co.kr



담당컨설턴트 : 최경숙부사장 ( 02-3450-1263 / kschoi@hrkorea.co.kr)





모집인원 1 명
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학력 대졸이상
연봉 Negotiable
외국어 영어커뮤니케이션가능자
경력제한 7년 이상
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