RA SPECIALIST
- Company
- 외국계 제약회사
- Position
- RA SPECIALIST
- Status
- CLOSE
외국계 제약회사에서 다음과 같이 “RA SPECIALIST” 업무를 하실 분을 찾습니다.
*서울 근무
{RESPONSIBILITIES}
- Pre-review new project dossier and set up regulatory strategy
- Prepare and compile application documents and justification with high quality in a scientific manner in line with local regulations
- Ensure that product registration obtained and maintained in line with the plan
- Provide appropriate regulatory supports to other departments
- Learn and deliver new or revised regulations & guidelines in a timely manner
- Prepare IND application in consistent with MFDS requirements and obtain IND approval
- Develop optimum solutions or possible scenarios in a timely manner when any issue is encountered and deal with the issue.
- All other duties as assigned from time to time, in accordance with the job profile.
{QUALIFICATIONS}
- Bachelor’s degree on pharmacy
- More than 5 years’ experience in RA
- Good project management skills and effective communication skills
- Comprehensive knowledge in pharmacy
- In-depth knowledge in pharmaceutical regulation
- Strategic problem solving skills
- A Fluent in English, both speaking and writing
Those who are interested in this opportunity, please submit your Resume (CV) 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.
KIM, Kyung Jin (Ian Kim)
CEO / Exdigm Inc.
M. 010-8722-1272
E. ceo@exdigm.com
U. www.exdigm.com
