•Compilation and preparation of dossiers as per local Pharmaceutical regulatory – MFDS requirement.
•Submission and co-ordination with MFDS and with regulatory / technical team at head quarter.
•Incase of requirement of doing local pharmaco-equivalence for injectable products, finding out and co-ordinating with local laboratory for performing it.
•Incase of local BE requirement for oral products, finding out suitable CRO and co-ordinating with local CRO and HO regulatory team.
•To support and coordinate between MFDS and Plant site for Site Inspection, if required.
•Prepare a regulatory plan for submissions and renewals and ensure implementation as per agreed timelines.
•Coordinate with the Regulatory Head Quarter (RA HO) & Regional RA Manager for query replies an all product submission status.
•Provides up to date Registration status and estimated timeline for submission/ MA Approval.
•Proactively provides input on the current and upcoming New Regulation/Guideline
경력 및 자격요건
•Atleast of 8 to 10 years professional experience in regulatory activities with MFDS including dossier submission.
•Should have worked in good local Korean companies.
•Fluent in English (Reading, writing and speaking).
•Good communicator with consultative style, multi-tasting abilities and efficient co-ordination with cross functional team.
•Should have a sound knowledge of and clarity of Pharmacology / Pharmacy & Therapeutic Segments of the products.
•At least Pharmacy graduate from South Korea’s reputable university.
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
