오펠라헬스케어 RA 채용
오펠라헬스케어 RA 채용관련하여 아래와 같이 안내드립니다.
[근무회사 및 모집부문]
* 근무회사: 고속터미널역에 위치한 프랑스계 글로벌 제약회사* 사업분야: 전문 의약품, 헬스케어, 백신, 의료기기 등* 모집부문: Regulatory Affair* 특이사항: 중식, 초과근무 수당, 선택적 복리후생비, 영어교육비 별도 제공[회사소개]- 프랑스에 본사를 둔 세계 선두의 헬스케어 기업으로, 국내에서는 전문의약품 및 건강기능식품을 공급하고 있으며, 이 외에도 백신, 희귀질환치료제를 통해 예방에서 치료까지, 환자들의 다양한 니즈에 부응하는 통합적인 헬스케어 기업으로 자리매김 하고 있습니다.
Purpose : Regulatory Support for main ASEA markets below, with focus on South Korea for Medicinal products, Nutraceuticals (Food Supplements, Functional Food, Dietary Supplements, Complementary medicines etc) and Cosmetics.
Specific for South Korea (50%), with focus on Functional Food Portfolio experience:
Contribute and provide insight for innovation programs leading to innovative regulatory pathways to drive competitive positioning, maximize chances of approval and identify opportunities, regulatory risks and mitigation strategies.
Prepare MFDS application according to local regulations/requirements/SOP and ensure filing submission and approval or support MFDS applications when MAH is held by 3rd party but the product is marketed under Opella Korea name
Manage/Maintenance of business/Company licenses
Review promotional materials and package materials to comply with local regulation and Sanofi SOP
Ensure that marketing authorizations are maintained in compliance with related regulatory areas, through performing the necessary activities, including variations and renewals and Secure product license by timely updating CMC, CCDS and safety information
Applicable for all ASEA markets (50%) :
- Coordinate and contribute to the preparation of the dossiers and responses document to Health Authority question with the stakeholders (Non-Clinical, Clinical Medical, Pharmacovigilance…)
- Accountable for the maintenance of the existing SEA Zone portfolio, managing the maintenance activities such as renewals, variations, discontinuation process via oversight of regulatory maintenance activities by local affiliates
- Ensure compliance of regulatory activities for development and marketed products as well as the update of regulatory database and regulatory requirements shared by local affiliates
- Oversight of SEA Zone projects and coordinating the communication to key stakeholders and ensure timely execution of planned regulatory activities as well as escalation of any risks and mitigation plans to ASEA Science team
- Follow regulatory changes, competitor’s status and assess potential impact on daily activities and project strategy
**자세한 JD는 이메일 문의 시 추가 공유드릴 예정입니다.
Bachelor of Sciences (Regulatory, Pharmaceutical or Pharmacy related fields preferred)
Min. 1-2 years of experience with Korean Functional Food Regulations (Imported and Locally produced)
Total experience of 3-5 years in market regulatory activities
Experience with MFDS would be preferred
Proficient in English and Korean Language (both spoken and written).
Good organization navigation, communication, and project management skills.
Good MS office skills (word/power-point/excel).
[근무환경]- 계약기간: 1년 (파견계약직, 계약 연장 가능성 있음)- 근무지: 서울시 서초구 반포동 (3, 7, 9호선 고속터미널역 5번 출구 부근 / 재택 병행)- 근무시간: 09:00 ~ 18:00 (유연근무제+재택근무 병행)
- 급여: 회사 내규 (경력직의 경우 경력년수 및 최종연봉에 따른 차등 지급)- 특이사항: 성과급, 중식, 초과근무 수당, 선택적 복리후생비, 언어교육비 별도 제공
- 온라인 접수 링크 : https://manpowergroupkorea.ninehire.site/job_posting/EYQ72SfF
- 제출서류: 국문 이력서 및 자기소개서 (MS Word 양식)- 담당자: 권보나, 02-6420-0309