SciGen is a rapidly growing biopharmaceutical company that markets and commercializes innovative and affordable healthcare products worldwide. We leverage our commercialization and networking capabilities to in-licenses and distribute branded pharmaceutical products and medical devices to treat endocrinological and oncological diseases, and continuously fill and improve our pipeline and product portfolio. Founded in the Asian Innovation Capital, Singapore in 1988, we currently have operations in Singapore, South Korea, Australia, China, Philippines and present commercially in all 6 continents. With the exceptional commercialization capabilities, regulatory expertise as well as international management experiences, and strategic partnerships built with industry and academic institutes, we strive to deliver hope and make a real and lasting difference to patients and their families. Who are we? - We believe in delivering solutions that matter to the people of today and innovating for the people of tomorrow. - To us, it is more than a business - it is a mission. What do we do? - We combine a specialty pharmaceutical business with a leading biologics biotechnology engine. - We partner to bring the best drugs we can find to the patients who need it most. How do we do it? - Our efforts aim to deliver better patient outcomes through better science. - We understand that humility and service matter as it is not about us, it is about making patients’ lives better.

포지션 및 자격요건

RA /PV Manager

( 1명 )

싸이젠코리아㈜는 1999년에 설립된 회사로 자본금 14억원, 매출액 295억, 사원수 34명 규모의 외국계(외국 투자기업)입니다. 서울 강남구 남부순환로377길 6 (도곡동)에 위치하고 있으며, 제약사업을 하고 있습니다. 


This position will play a key role in regulatory affairs and pharmacovigilance submissions to ensure the successful delivery of an overall regulatory plancompliance. The person will interact with the regional teams, ensuring regulatory plans are able to meet the business goals. The role will be exposed to a variety of regulatory activities and, in time, will be given the opportunity to take on more strategic regulatory responsibilities as the role grows alongside personal capability and potential. 



Key Responsibilities

●        Responsible for leading the preparation and review of day-to-day regulatory submissions with full accountability for delivery

●        Responsible for the maintenance activities associated with approved pharmaceutical products and/or device registration

●       Support due diligence projects and regulatory intelligence for specific product(s)

●        Work with the regional regulatory representative to develop regulatory strategies

●       Ensure quality of work and in compliance with regulatory guidelines and processes within required timelines

●       PV responsible for RMP management and related pharmacovigilance activities

●        Lead and support activities related to Ministry of Food and Drug Safety (“MFDS”) on site inspections 

●        Reports to Head of RA/QA/PV, Korea


Job Requirements

●   Bachelor’s degree in pharmacy, biological or related chemical sciences

●    At least eight (8) years in regulatory affairs and/or pharmacovigilance of pharmaceuticals products and/or medical devices

●     Comprehensive knowledge and understanding on regulatory requirements applicable to pharmaceutical product registrations and/or safety data management in Korea

●    Good communication and interpersonal skills in both Korean and English to support correspondences with health authorities, external partners and cross-functional teams including from Singapore Headquarters

●     Knowledge of regulatory agency guidelines and expectations in regulatory submission processes

●       Able to work independently and meticulously


우대사항

ㆍ영어능통자

ㆍ전공 : 간호, 약학, 생물 또는 화학 관련 전공 


전형절차

ㆍ서류전형 > 면접전형 > 종합심사 > 최종합격

ㆍ면접일정은 서류전형 통과자에 한해 통보됩니다.


유의사항

ㆍ허위사실이 발견될 경우 채용이 취소될 수 있습니다.