[KOREA] Regulatory Affairs Manager
[KOREA] Regulatory Affairs Manager
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Not Disclosed
Salary Not Disclosed
1 Vacancy
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
- Working experiences in Korean regulatory fields more than 7 years
- Working experiences to register Korean NDA for NCE drugs or BLA
- Preferable to have experiences on medical devices
- Essential qualification
- A pharmacist in Korea
- Depth knowledge of Korean legislation and regulations relating to medicinal products
- Depth understanding of the registration procedures and challenges in Korea for NDA and all activities for lifecycle managements
- Skills
- Fluent in Korean and English
- 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
Remote Work :
No
Employment Type :
Full-time
Employment Type
Full-time
