[근무회사 및 모집부문]
- 근무회사: 덴마크에 본사를 둔 글로벌 제약회사

- 사업분야: 조울증, 조현병, 알츠하이머, 파킨슨 병등 중추신경계(CNS) 약제 개발/판매
- Position: RA Specialist

[업무내용]

MA Maintenance

- Ensure products are maintained and meet internal and external compliance requirements.

- Submissions for MA renewal/variations to MFDS

MA Approval

- Preparation of new regulatory documents, dossiers and applications to enable products to be launched and maintained in market, with the correct alignment and compliance to regulations.

- Participating all of the following activities: development of product plan, regulatory strategy, risk management, implementation plan, chemistry manufacturing control (CMC)

- IND/CTA CA submission & approval: Supporting for regulatory submission and approval for clinical trials (e·g·, Preparation of Korean translated IMPDs, protocols, Investigator's Brochure etc.)

Regulatory compliance

- Follow up regulatory issues.

- Collaborative working together with other functions (e.g., marketing, medical, supply chain)

- Maintains required regulatory compliance databases, systems and processes.

QA related works

- Preparation of regulatory CMC documents

- Preparation of GMP inspections and submission of CAPAs to the MFDS.

[지원자격]

- Licensed pharmacist eligible for registration as a pharmaceutical import manager

- Preferred experience in regulatory affairs for biological new products

- 3-5 years of experience in RA (Regulatory Affairs), Regulatory СМС, and pharmaceutical import management

- Proficiency in spoken and written English

[근무환경]
- 근무형태: 맨파워코리아 소속 파견계약직 12개월 (출산휴가 대체 포지션)

- 근무지: 서울 송파구 올림픽로 35길 137 (2호선 잠실역 부근)

- 근무시간: 09:00 ~ 18:00 (주 1회 재택근무)
- 급여: 경력 별 협의

- 복리후생:  4대보험, 연차(수당), 우수사원시상, 생일/명절선물, 경조사 지원, 여름휴가 5일, 자기개발비(영어교육), 통신비 지원, 점심식사 지원, 직원실비보험 등

[지원방법]
- 홈페이지 지원: 지원하기! 클릭 
- 제출서류: MS-word 양식의 이력서
- 담당자: 오연희 주임 (02-6420-0374)

** 서류전형 합격자에 한해 개별 연락 드립니다.
** 합격자 발생 시 공고가 마감되므로 빠른 지원 결정 부탁드립니다.