•In coordination with Sr. Regulatory Affairs Supervisor, develop effective product registration approval strategies. Directly involves in the product approval ensuring timely market access of new products
•Build and maintain close relationships/communication with officials of these government agencies and relevant stakeholders, to ensure smooth and timely product approval. Monitor changes and feedback information regarding critical development in these regulations to Sr. Regulatory Affairs Supervisor and its team.
•Actively participate in industry activities to influence favorable regulatory policies for company interest.
•Provide status report and submission and approval status of registration to Sr. Regulatory Affairs Supervisor.
•Establishes and maintains reasonable and responsible regulatory climates locally through good networking (e.g. with SBU RA and other cross-functional/sector/category/regional/colleagues).
경력 및 자격요건
•At least 3 years Regulatory Affairs experience in medical devices or pharmaceutical industry
•RAC (Regulatory Affairs Certificate) preferred
•Experience of Combination Product Approval or New Drug Approval is preferred
•Excellent verbal and written English communication and interpersonal skills
기타
- 원서 마감후 1차(서류) 합격자에 한하여 개별연락
- 이력서에 연락처, 희망연봉 게재
- 해외여행에 결격 사유가 없는 자
담당업무
입사지원
돌아가기
02-6281-5015
yhw@nterway.com
