• Compile and submit, in a timely manner, regulatory documents according to regulatory requirements
• Prepare, review, and approve labeling and SOP’s. Supervise lower level team members on complex issues.
• Provide regulatory advice to project teams.
• Provide guidance and coaching for areas of responsibility to lower level team members.
• Respond to regulatory authorities questions with strict deadlines
• Maintain regulatory files in a format consistent with requirements• Develop and initiate complex regulatory project plans
• Manage regulatory activities relating to specific portfolio of products/projects (product owner)
• Maintain and update existing regulatory authorizations
• Lead or represent Regulatory Affairs in project teams
• May review promotional material for compliance with local regulations
경력 및 자격요건
Education:
-Bachelor’s degree or country equivalent in pharmacy or related scientific discipline with a minimum of 5 years regulatory or equivalent experience within a pharmaceutical company, CRO, or similar organization.
Competency Required:
-Negotiation skills
-Professional knowledge of regulatory science
-Excellent interpersonal communication skills
-Proficiency in English
기타
- 원서 마감후 1차(서류) 합격자에 한하여 개별연락
- 이력서에 연락처, 희망연봉 게재
- 해외여행에 결격 사유가 없는 자
담당업무
입사지원
돌아가기
02-6281-
ymlee@nterway.com
