[KOREA] RA Specialist (NEW Position) at Santen

Seoul, , South Korea -

Full Time

Start Date

Immediate

Expiry Date

15 Jun, 26

Salary

0.0

Posted On

17 Mar, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Affairs, NDA Submission, Variation Submission, Korean Legislation, Pharmaceuticals, Biologics, Change Control Evaluation, Regulatory Monitoring, Korean HA Interaction, Artwork Creation, Korean Language, English Language

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 Prepare Korean applications for NDA for new products and variations for approved products of Santen Korea allocated by the head of RA in SKR and submit the application for NDA(s) or variation(s) to Korean HA (MFDS). Respond to any request of K-HA in a timely manner by preparing relevant documents to be submitted to HA on time under the supervision of the head of RA in SKR. Evaluate change controls and review its requirements along with the expected schedule under the supervision of the head of RA in SKR. 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 SKR. Comply with local regulations, guidelines etc. and provide regulatory insights to relevant functional members under the direction of the head of RA in SKR. Create local artworks written in Korean to be complied with local regulation, internal standards etc. Monitor new and/or updated KR regulations, guidelines, direction of Korean HA etc. Qualifications Bachelor degree in Pharmacy is highly preffered or Life Scicence any related field Knowledge of Korean legislation and regulations for pharmaceuticals (preferable for both chemicals and biologics) Understanding of the registration procedures in Korea for NDA, variations, K-DMF and other regulatory scopes (preferable for both chemicals and biologics) Working experience for RA at pharmaceutical company(s) in Korean for more than 3 years (preferably to have RA experience in foreign pharmaceutical company(s)) Working experiences to register K-NDA and/or variations (Preferably to have both experiences for NDA and BLA) Preferably to have experience leading a regulatory project from the beginning Fluent in Korean and English (Reading, writing and speaking) Additional Information 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 specialist will be responsible for preparing and submitting Korean New Drug Applications (NDA) and variations for approved products to the Korean Health Authority (MFDS). This includes responding to regulatory requests, evaluating change controls, monitoring local regulations, and creating compliant Korean artwork.