노바티스는 혁신적인 신약 연구를 최우선으로 하고 있습니다. 혁신적인 신약은 의료 분야의 새로운 길을 개척할 뿐만 아니라, 충족되지 못한 의학적 필요에 대한 해답이기 때문입니다. 그러나 어떤 환자도 똑같을 수 없다는 것을 압니다. 노바티스는 혁신적인 신약 개발을 넘어 질병을 예방하고 의약품에 대한 접근성 제공을 위해 노력하고 있습니다.
한국 노바티스에서 경력사원을 모집하고 있습니다.
노바티스 홈페이지(www.novartis.co.kr)를 방문하신 후 Job ID를 참조하여 지원하고자 하는 공고에 apply 부탁 드립니다.
지원하고자 하는 Job ID를 클릭하시면 Job Description을 보실 수 있습니다.
* RA Specialist : 249072BR
**지원 방법** (꼭 시스템을 통하여 지원하셔야 합니다)
1. http://www.novartis.co.kr/ 홈페이지에 방문
2.우측 상단 채용 공고(BrassRing)을 클릭 후 지원하고자 하는 공고를 클릭 (지원하고자 하는 Job ID 참조)
* 시스템 이외의 방법으로 지원하신 서류는 반영되지 않습니다 *
**Job Description**
1. Review pipeline and set the registration strategy in collaboration with global RA and related CPO functions with support from senior specialist and manager
2. Achieve the best product registration with optimal label by conducting research on submission requirements and approval lead time in accordance with registration plan
3. Support launches (artwork, barcode, Drug ID mark, etc.)
4. Support CTA Hub and collaborate with other CPO functions, if needed
5. Maintain product license by managing variations for label, quality (CMC and mfg. site) and administrative changes according to local law/regulation/guidelines, company strategy and global compliance.
6. Secure product license by managing Reevaluation/Renewal/Reexamination /HA safety communication
7. Ensure post approval activities (website, artwork, etc.)
8. Submit RMP by supporting of other function in line with global direction
9. Be accountable for correct and timely update of RA compliance (registration) database (DRAGON, etc)
10. Ensure industry compliance with P3, NP4 and KRPIA code of conduct
11. Support cross functional activities by delivering regulatory input
12. Understand basic knowledge on the legal frameworks, internal processes, GxP’s
13. Keep abreast of relevant laws /regulations and apply to related CPO activities
14. Ensure reporting and follow up of all spontaneous adverse events (AE) and technical complaints for all Novartis products according to respective regulation and SOP
15. Foster and maintain good relations with internal and external stakeholders
16. Communicate effectively with HA and other SHs including x-functional team
17. Understand RA internal working process and handle own task properly and timely manner
**Job Requirements**
1. 4 years university degree
2. Preferably majored in pharmacy, (Bio)chemistry and life science
3. Minimum 2 years work experience in RA
4. Fluent in both written and spoken English
한국 노바티스에서 경력사원을 모집하고 있습니다.
노바티스 홈페이지(www.novartis.co.kr)를 방문하신 후 Job ID를 참조하여 지원하고자 하는 공고에 apply 부탁 드립니다.
지원하고자 하는 Job ID를 클릭하시면 Job Description을 보실 수 있습니다.
* RA Specialist : 249072BR
**지원 방법** (꼭 시스템을 통하여 지원하셔야 합니다)
1. http://www.novartis.co.kr/ 홈페이지에 방문
2.우측 상단 채용 공고(BrassRing)을 클릭 후 지원하고자 하는 공고를 클릭 (지원하고자 하는 Job ID 참조)
* 시스템 이외의 방법으로 지원하신 서류는 반영되지 않습니다 *
**Job Description**
1. Review pipeline and set the registration strategy in collaboration with global RA and related CPO functions with support from senior specialist and manager
2. Achieve the best product registration with optimal label by conducting research on submission requirements and approval lead time in accordance with registration plan
3. Support launches (artwork, barcode, Drug ID mark, etc.)
4. Support CTA Hub and collaborate with other CPO functions, if needed
5. Maintain product license by managing variations for label, quality (CMC and mfg. site) and administrative changes according to local law/regulation/guidelines, company strategy and global compliance.
6. Secure product license by managing Reevaluation/Renewal/Reexamination /HA safety communication
7. Ensure post approval activities (website, artwork, etc.)
8. Submit RMP by supporting of other function in line with global direction
9. Be accountable for correct and timely update of RA compliance (registration) database (DRAGON, etc)
10. Ensure industry compliance with P3, NP4 and KRPIA code of conduct
11. Support cross functional activities by delivering regulatory input
12. Understand basic knowledge on the legal frameworks, internal processes, GxP’s
13. Keep abreast of relevant laws /regulations and apply to related CPO activities
14. Ensure reporting and follow up of all spontaneous adverse events (AE) and technical complaints for all Novartis products according to respective regulation and SOP
15. Foster and maintain good relations with internal and external stakeholders
16. Communicate effectively with HA and other SHs including x-functional team
17. Understand RA internal working process and handle own task properly and timely manner
**Job Requirements**
1. 4 years university degree
2. Preferably majored in pharmacy, (Bio)chemistry and life science
3. Minimum 2 years work experience in RA
4. Fluent in both written and spoken English