[KOREA] Regulatory Affairs Manager

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.

[Position Brief] 

• Prepare Korean applications for NDA for new products and variations for approved products of Santen Korea (SKR) allocated by RA head of SKR, and then submit the application for NDA or variation to get the approval from Korean HA by handling supplementary requests of HA accordingly under the supervision of RA head of SKR.
• 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 RA head of SKR.
• Evaluate change controls and review its requirements along with the expected schedule for it under the supervision of RA head of SKR.
• Develop artworks and proceed update of artworks along with relevant variation etc. under the supervision of RA head of SKR.

Job Description

• Report to RA head for all RA tasks in SKR (Santen Korea) in a timely manner

• Follow up the instruction of RA head in SKR in a timely manner

• Comply with local regulations, guidelines etc. and provide regulatory insights to relevant functional members.

• Prepare applications and/or documents written in Korean under the supervision of RA head in SKR.

• Discuss with RA head to develop regulatory strategy for each task and execute it to provide better business opportunities for SKR.

• Conduct close communication with reviewers in HA for the submitted application

• Ensure timely registration of new products and/or submitted variations

• Create and manage local artworks written in Korean to be complied with local regulation, internal standards etc.

• Review artworks & promotional material

• Monitor local new and/or updated regulations, guidelines, direction of Korean HA etc., and share it with relevant members

• Collaborate with other relevant functional members for ongoing or planned tasks

• Any others instructed by RA head in SKR

Qualifications

• Essential experiences
  1. Working experiences in Korean regulatory fields more than 7 years
  2. Working experiences to register Korean NDA for NCE drugs or BLA
  3. Preferable to have experiences on medical devices

• Essential qualification
  1. A pharmacist in Korea
  2. Depth knowledge of Korean legislation and regulations relating to medicinal products
  3. Depth understanding of the registration procedures and challenges in Korea for NDA and all activities for lifecycle managements

• Skills
  1. Fluent in Korean and English
  2. Sufficient knowledge on Korean regulations and pharmacy

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