[KOREA] RA specialist (2-Years-Contract)
[KOREA] RA specialist (2-Years-Contract)
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1 Vacancy
Job Description
All regulatory tasks are closely linked to the business sustainability of Santen Korea by maintaining all
essential licenses for approved products and providing new business opportunities to Santen Korea as
quickly as possible by getting approval of new products in KR.
Each regulatory task will be evaluated and allocated depending on its level of difficulty and the competence of the person aligned with this JD by the head of RA.
Prepare Korean applications for NDA (New Drug Applicatoin) for new products and variations for approved products of Santen Korea allocated by the head of RA in Santen Korea and submit the application for NDA(s) or variation(s) to Korean HA (Korean Health Authority) (MFDS)
Respond to any request of K-HA (Korean Health Authority) in a timely manner by preparing relevant documents to be submitted to HA on time under the supervision of the head of RA in Santen Korea.
Evaluate change controls and review its requirements along with the expected schedule under the supervision of the head of RA in Santen Korea
Monitoring local regulations and/or guidelines and sharing them with relevant stakeholders in a timely manner under the supervision of the head of RA in Santen Korea.
- Report to the head of RA for all tasks allocated in a timely manner to be complied with Follow up the instruction of the head of RA in Santen Korea in a timely manner to be complied with Prepare applications and/or documents for both NDA (New Drug Applicatoin) and variations written in Korean
- Mainly allocated to variations through the evaluation of the level of difficulty of each project and competency of him(her) under the supervision of the Head of RA
- Partial RA tasks for K-NDA (Korea New Drug Applicatoin) could be allocated under the supervision of the head of RA in Santen Korea
- Regulatory actions for K-DMF (Drug Master File) registration and maintenance under the supervision of the Head of RA in Santen Korea
- Timely submission of KR application(s) to HA (Korean Health Authority) under the supervision of the Head of RA
- Conduct regulatory feasibility review or regulatory gap analysis under the supervision of the Head of RA
- Conduct close communication with reviewers in HA (Korean Health Authority) for the submitted application(s)
- Ensure timely registration of new products and/or submitted variations
- Comply with local regulations guidelines etc. and provide regulatory insights to relevant functional members under the direction of the Head of RA in Santen Korea
- Create local artworks written in Korean to be complied with local regulation internal standards etc.
- Review of artworks & promotional materials
- Monitor new and/or updated KR regulations guidelines direction of Korean HA (Korean Health Authority) etc.
- Collaboration with other relevant functional members for ongoing or planned tasks
- Others instructed by the Head of RA
Qualifications :
Knowledge and Skill
- A Licenced pharmacist in Korea is preferred
- Knowledge of Korean legislation and regulations for pharmaceuticals (preferable for both pharmaceuticals and medical devices is a plus)
- Understanding of the registration procedures in Korea for NDA (New Drug Applicatoin) variations of drugs K-DMF(Drug Master File) and other regulatory scopes (preferable for both drugs and medical devices is a plus)
- Fluent in Korean and English (Reading writing and speaking)
- Communication skills
Job Competency
- Working experience for RA at pharmaceutical company(s) in Korean for more than 2 years (preferably to have RA experience in foreign pharmaceutical company(s)).
- However a pharmacist who doesnt have any RA experience could be selected as an alternative through comprehensive evaluation by the head of RA in Santen Korea
- Working experiences to register K-NDA (New Drug Applicatoin) and/or variations of drugs (Preferably to have both experiences for NDA of ETC and OTC)
- Preferably to have experience leading a regulatory project from the beginning
- Preferably to have RA experiences for medical devices is a plus
Additional Information :
Please submit the resume in Resume Format template.
Submit in 2 languages please. (Korean & English)
Grow your career at Santen
A career at Santen is an opportunity to make a difference. Through our long-term vision outlined in Santen 2030 we are committed to be a Social Innovator - addressing the social and economic needs of people with visual impairments. We have team members around the world using their diverse talents to unlock new modalities and drive innovations for patient outcomes education and treatment. At Santen we believe in empowering all our team members with flexible ways of working and a highly inclusive work environment.
The Santen Group is an Equal Opportunity Employer. We are committed to building diverse teams and ensuring a safe and inclusive physical and virtual workplace for every one of our team members. All employment decisions are based on business needs role requirements and individual qualifications regardless of race color ethnicity national origin/ancestry religion sexual orientation gender gender identity/ expression age disability medical condition marital status veteran status or any other characteristic protected by law.
If you require any kind of accommodation during our recruitment process please let the recruiter from our team know.
*Please note that team assignments may be subject to future changes
Remote Work :
No
Employment Type :
Contract
Employment Type
Contract
