유명 바이오 제약회사에서 다음과 같이 'Regulatory Advisor'를 찾고 있습니다.
* Position: Regulatory Advisor
* Department: Regulatory Affairs Team
* Location: Songdo

[RESPONSIBILITIES]
With expertise and insight, provide support for the establishment of the regulatory organization, enhancement of regulatory capabilities of team members, and preparation/processing of product registration.
1. Support the development of regulatory manuals and SOPs
2. Support the establishment of the regulatory organization (CMC regulatory group, Regulatory intelligence and liaison group, Regulatory operation, etc.)
3. Support the enhancement of regulatory capabilities (CMC regulatory group, Regulatory intelligence and liaison group, Regulatory operation, etc.)
4. Support regulatory strategy development
5. Support the development and authoring of regulatory documents (BD, IMPD, CTD, etc.)
6. Support regulatory liaison and global networking
7. Provide consultation on all regulatory related issues

[QUALIFICATIONS]
- Degree in a relevant clinical/regulatory subject or the equivalent demonstrable work experience
- Expertise to review and evaluate medical data
- Fluent in English
- Excellent communication and interpersonal skills, both written and verbal enabling you to deal with queries in a timely manner
- Ability to produce accurate work to tight deadlines within a pressured environment
- Computer literate with Microsoft Office

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

Kyung Jin KIM
CEO & Executive Search Consultant
Exdigm Inc
Phone: 070-8260-3646
Mobile: 010-8722-1272
Email: ceo@exdigm.com