RA (Regulatory Affairs)
- Company
- 외국계 제약회사
- Position
- RA (Regulatory Affairs)
- Status
- CLOSE
외국계 제약회사에서 다음과 같이 “RA (과장-대리급)” 를 찾습니다.
* Job Title : RA (Regulatory Affairs)
* Position : 대리 - 과장
* Report to Head of RA
* Gender : Male or Female
* Location : 서울
* Job Title : RA (Regulatory Affairs)
* Position : 대리 - 과장
* Report to Head of RA
* Gender : Male or Female
* Location : 서울
[RESPONSIBILITIES]
- Registration feasibility pre-review
- Preparation of K-NDA, K-ANDA or K-IND files
- DMF and/or GMP site inspection
- Maintenance and update of registered products
- Other duties as assigned
- Registration feasibility pre-review
- Preparation of K-NDA, K-ANDA or K-IND files
- DMF and/or GMP site inspection
- Maintenance and update of registered products
- Other duties as assigned
1. Execute preparations of the application files and follow ups for marketing authorization approval (허가 신청자료 작성 및 준비 및 업무 follow up)
2. Proceed IND submissions and handling according to project plan in timely manner and communication with relevant authority (임상시험계획서 제출 및 승인 일정 수립, 요구되는 자료를 작성하여 제출 및 식약청 등 관련기관과 communication)
3. Set up regulatory strategy through dossier review regarding new project (도입 또는 개발 검토 제품 개발에 대한 지원 및 허가전략 수립)
4. Proceed maintenance existing products (MA variations, annual report such as DMF, re-evaluation including renewal, withdrawal etc.) (제품허가 변경 및 유지에 관한 업무)
5. Follow up new registration on going status and MFDS’s queries and deficiency letter (보완자료에 대한 적절한 대응 및 follow up
2. Proceed IND submissions and handling according to project plan in timely manner and communication with relevant authority (임상시험계획서 제출 및 승인 일정 수립, 요구되는 자료를 작성하여 제출 및 식약청 등 관련기관과 communication)
3. Set up regulatory strategy through dossier review regarding new project (도입 또는 개발 검토 제품 개발에 대한 지원 및 허가전략 수립)
4. Proceed maintenance existing products (MA variations, annual report such as DMF, re-evaluation including renewal, withdrawal etc.) (제품허가 변경 및 유지에 관한 업무)
5. Follow up new registration on going status and MFDS’s queries and deficiency letter (보완자료에 대한 적절한 대응 및 follow up
[QUALIFICATIONS]
- Over 5 years’ experience in pharmaceuticals with at least?3 years in RA
- Pharmacy, Biology, biochemistry, chemistry etc
- Good project management skills and effective communication skills
- English skills (writing, communications)
- Over 5 years’ experience in pharmaceuticals with at least?3 years in RA
- Pharmacy, Biology, biochemistry, chemistry etc
- Good project management skills and effective communication skills
- English skills (writing, communications)
Those who are interested in this opportunity, please submit your Resume in MS Word Format by email urgently. Only qualified candidates will be contacted for interview. All resumes not contacted will be kept in DB confidentially for future positions.
