[KOREA] Regulatory Affairs Specialist (2-Years-Contract) at Santen

Seoul, , South Korea -

Full Time

Start Date

Immediate

Expiry Date

19 Jan, 26

Salary

0.0

Posted On

21 Oct, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Affairs, Pharmaceuticals, Medical Devices, Korean Legislation, NDA, K-DMF, Communication Skills, English Fluency, Korean Fluency, Change Control, Document Preparation, Local Regulations Monitoring, Stakeholder Engagement, Timely Reporting, Application Submission

Industry

Pharmaceutical Manufacturing

Description

Company Description Santen is a specialized life sciences company with a proud 130-year heritage focused exclusively on ophthalmology. As a Japan-originated, global company with our footprint in over 60 countries, we are dedicated to delivering innovative treatments and digital solutions for eye health and addressing vision-related social issues for people around the world. 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 Korea. 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 it's 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 Monitor new and/or updated KR regulations, guidelines, direction of Korean HA (Korean Health Authority) etc. Qualifications A Licenced pharmacist in Korea or Science education background 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 English (Reading, writing and speaking) & Korean Excellence in Communication skills 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 doesn’t have any RA experience could be selected as an alternative through comprehensive evaluation by the head of RA in Santen Korea 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

Responsibilities

The Regulatory Affairs Specialist will manage regulatory tasks to maintain essential licenses for approved products and expedite the approval of new products in Korea. Responsibilities include preparing applications for NDA and variations, responding to requests from the Korean Health Authority, and monitoring local regulations.