[모집개요]
회사 : 외국계제약회사
포지션 : (Sr.)RA Specialist(과장급)
회사위치 : 강남
[모집부문]
직위 : 과장급
담당업무 : (Sr.)RA Specialist(과장급)/외국계제약회사

강남에 위치한 유럽계제약회사에서 (Sr.) RA Specialist(과장급)를 찾습니다.

Position Summary:
 Execute regulatory activities from policy to completion.
 Provide guidance for the decision making process relating to regulatory issues.
 Manage Regulatory submissions for all products in responsible countries.
 Compile information from multiple sources for regulatory filing, writing summaries and other necessary documentation.

Essential Duties and Responsibilities:

1. Make a plan for the product approval and maintain the marketing authorization including PMS study, variations, annual reports and any regulatory process for both stages of pre-approval and post-approval.
2. Execute preparations of the application files and follow ups for marketing authorization approval.
3. Effectively manage project timelines as defined by department and corporate objectives.
4. Monitor Korean regulations and trend of global regulations and standards to ensure that Company systems comply with requirements for import and distribution of pharmaceuticals, medical devices, functional food and cosmetics, ensuring compliance with the most stringent applicable laws and regulations.
5. Participate in third party audits of the GMP, and assist with coordinating, compiling, and submitting responses to any observations made during those audits.
6. Review and approval of documentation for regulatory compliance, including product, process and software validation.
경력요건 : Position Requirements :
Pharmacist license is required
At least 4 years experience in a lead regulatory role at pharmaceutical company
Pharmaceutical drug registration experience is mandatory
Excellent interpersonal skills.
영어 가능하신 분
연령 : 30대 초반-중반의 분
학력 : 정규대졸
어학 : 영어
컴퓨터 : .
연봉 : 협의
특이사항 : .
[담당자/문의처]
담당자 : 원현숙상무
전화 : 02-2050-0299
제출서류 : 영문이력서, 자기소개서
전자우편 : hs@mstone.co.kr