서울 강남구 대치동 945-10KT＆G 대치타워 12층
다케다제약은 1781년 설립되어, 올해 창립 232주년을 맞는 일본 오사카에 본사를 둔 글로벌 제약회사입니다. 일본 내 1위, 아시아에서는 18조원의 매출을 기록하며 업계 1위를 자랑하는 다케다제약은 ‘공정’’정직’’불굴’의 기본가치를 바탕으로 삼아 성실(Integrity)이라는 경영철학을 실천하기 위해 노력하고 있습니다. 2만명 이상의 직원이 전 세계 여러 국가에서 일하고 있으며, 한국에서는 2010년 8월에 법인설립을 시작으로 한국제약시장의 중추적인 역할을 하기 위한 첫발을 내디뎠습니다.
지원분야
모집부문
Regulatory Affairs Associate 계약
Regulatory Affairs Associate 계약
업무내용
[Purpose of Job]
The Regulatory Affairs Associate is responsible for assisting in timely and efficiently managing drug registration process from beginning to end in accordance with regulatory requirements.
[Organizational Relationship]
- This position reports directly to the Regulatory Affairs Manager.
- Projects, priorities and responsibilities are determined through interactions with Regulatory Affairs Manager and/or RA Director.
- Primary interactions to effect changes in procedures and working practices are made with the Regulatory Affairs Manager.
- Close working relationships with the relevant regulatory authorities and associations are developed and maintained to facilitate and positively influence all regulatory interactions.
- Interactions with Reginal and/or Global RA team helps to provide a global perspective of the role/responsibilities assigned to this function.
[KEY Accountabilities and Responsibilities]
- Assists in obtaining marketing approval from the MFDS for a planned new drug(K-NDA) and ensures subsequent maintenance of drugs registered (Supplemental & Amended K-NDA)
- Ensures registered products are maintained and updated in full compliance with all relevant legislation and SOPs.
- Provides regulatory affairs related information to other departments.
- Assists Regulatory Affairs Manager to establish, develop and maintain close working relationships with the relevant regulatory authorities and associations (MFDS, MOHW, KJPA etc.)
- Assists Regulatory Affairs Manager for coordinating regulatory activities among departments (Marketing, Business Development etc.) and timely communications with Region, Headquarter and Millenium.
- Assisits Regulatory Affairs Manager to develop new product registration strategy.
[Essential responsibilities]
- Registration feasibility pre-review
- Preparation of K-NDA files
- DMF and/or GMP site inspection
- Maintenance and update of registered products
- Product label management
- Interactions with Region
- Other duties as assigned
[Purpose of Job]
The Regulatory Affairs Associate is responsible for assisting in timely and efficiently managing drug registration process from beginning to end in accordance with regulatory requirements.
[Organizational Relationship]
- This position reports directly to the Regulatory Affairs Manager.
- Projects, priorities and responsibilities are determined through interactions with Regulatory Affairs Manager and/or RA Director.
- Primary interactions to effect changes in procedures and working practices are made with the Regulatory Affairs Manager.
- Close working relationships with the relevant regulatory authorities and associations are developed and maintained to facilitate and positively influence all regulatory interactions.
- Interactions with Reginal and/or Global RA team helps to provide a global perspective of the role/responsibilities assigned to this function.
[KEY Accountabilities and Responsibilities]
- Assists in obtaining marketing approval from the MFDS for a planned new drug(K-NDA) and ensures subsequent maintenance of drugs registered (Supplemental & Amended K-NDA)
- Ensures registered products are maintained and updated in full compliance with all relevant legislation and SOPs.
- Provides regulatory affairs related information to other departments.
- Assists Regulatory Affairs Manager to establish, develop and maintain close working relationships with the relevant regulatory authorities and associations (MFDS, MOHW, KJPA etc.)
- Assists Regulatory Affairs Manager for coordinating regulatory activities among departments (Marketing, Business Development etc.) and timely communications with Region, Headquarter and Millenium.
- Assisits Regulatory Affairs Manager to develop new product registration strategy.
[Essential responsibilities]
- Registration feasibility pre-review
- Preparation of K-NDA files
- DMF and/or GMP site inspection
- Maintenance and update of registered products
- Product label management
- Interactions with Region
- Other duties as assigned
고용형태
계약직
계약직
지원 자격
직무관련
- Bachelor's degree in a scientific field required
- If no RA work experience, pharmacist preferred
- Bachelor's degree in a scientific field required
- If no RA work experience, pharmacist preferred
우대사항
- 1~3 years experience in regulatory affairs preferred, but not mandatory
- 1~3 years experience in regulatory affairs preferred, but not mandatory
지원서접수
지원방법
지원하기 클릭 → 왼쪽 하단의 채용공고 클릭
지원하기 클릭 → 왼쪽 하단의 채용공고 클릭
접수기간
12월 22일 09:00 ~ 02월 03일 02:14
(채용시 조기 마감될 수 있습니다)
12월 22일 09:00 ~ 02월 03일 02:14
(채용시 조기 마감될 수 있습니다)
전형절차
서류전형
면접전형
추가 정보
기타정보
계약기간: 18개월 (Direct contract, 1 year 6 months)
계약기간: 18개월 (Direct contract, 1 year 6 months)
* 마감일은 기업의 사정으로 인해 조기 마감 또는 변경될 수 있습니다
