Topheadhunter
즐겨찾기에 추가  HOME | 공지사항 | 자료실 | Sitemap | Contact Us   
 
 
  
헤드헌팅
간부급 헤드헌팅
외국인 헤드헌팅
정부기관 및 산하연구소 채용정보
 
Regulatory Affairs Manager in Multinational Pharmaceutical Company
[Company Status]
Multinational Pharmaceutical Company(MNC) is wholly owned sales subsidiary in United Kingdom of Intas Pharmaceuticals Ltd. India which is having 1.3 billion USD sales revenue and more than 20 sales subsidiaries and representative offices across world including US, Canada, UK, Spain, France, Australia, Dubai, South Africa, Brazil, Mexico etc… MNC is having more than 150 pharmaceutical molecules approved in Europe in various therapies including Oncology, Cardio-Vascular, Nephrology, Gastro-intestinal, Central Nervous System, Auto-immune diseases. And also selling more than 30 pharmaceutical products in US.
As part of expansion in Asian markets, MNC would like to start subsidiary and office in South Korea to manage regulatory, sales and business development activities for it’s pharmaceutical products approved in EU and US markets and manufactured in state-of-art sites having US-FDA, MHRA-UK, TGA-Australia cGMP certifications.
For the same, MNC is looking for a suitable candidate to manage regulatory activities with MFDS-Korea in South Korea.

[Job Title]
Regulatory Affairs Manager

[Reporting to]
Direct report: Regional Business Head - North Asia
Functional Reporting: Regional Regulatory Manager - APAC

[Experience]
- At least 8 to 10 years professional experience in managing ethical pharmaceutical products (generics) regulatory / registration activities with MFDS-Korea.
- Must be License Pharmacist

[Location]
Seoul, South Korea

[Function]
Regulatory Affairs

[Products]
Portfolio of Pharmaceutical generic molecules (Oncology & Non-Oncology)

[Job Profile]

Regulatory Affairs:
• Compilation and preparation of dossiers as per local South Korea Pharmaceutical regulatory – MFDS requirement.
• Submission and co-ordination with MFDS-South Korea and with regulatory / technical team at head quarter.
• Incase of requirement of doing local pharmaco-equivalence for injectable products, finding out and co-ordinating with local laboratory for performing it.
• Incase of local BE requirement for oral products, finding out suitable CRO and co-ordinating with local CRO and HO regulatory team.
• To support and coordinate between MFDS and Plant site for Site Inspection, if required.
• Prepare a regulatory plan for submissions and renewals and ensure implementation as per agreed timelines.
• Coordinate with the Regulatory Head Quarter (RA HO) & Regional RA Manager for query replies an all product submission status.
• Provides up to date Registration status and estimated timeline for submission/ MA Approval.
• Proactively provides input on the current and upcoming New Regulation/Guideline and assess possible impact to registered/ upcoming registration product.
• Responsible for all Pharmacovigilance / Quality Complaint Report to be reported to RA / QA Head quarter.

Supporting Activities:
• Supporting administrative role (if whenever necessary) for subsidiary operations in South Korea.

Desired Experience:
• Atleast of 8 to 10 years professional experience in regulatory activities with MFDS including dossier submission.
• Should have worked in good local Korean companies.
• Fluent in English (Reading, writing and speaking).
• Good communicator with consultative style, multi-tasting abilities and efficient co-ordination with cross functional team.
• Should have a sound knowledge of and clarity of Pharmacology / Pharmacy & Therapeutic Segments of the products.

Required Education:
• At least Pharmacy graduate from South Korea’s reputable university.

Foreign Languages:
Should be proficient in English & Korean Local Language

[Reasons for Recruitment]
New start up

[Date]
ASAP

[Number of Persons] 1

[Salary Expectation]
Negotiable(USD80,000~USD1,10,000

[Foreign Languages] English

[Apply a Position]
Please send your English resume(Documents/ CVs must be written in English)A.S.A.P (MS word only)by E-mail top@topheadhunter.co.kr
* The title of E-mail should be Regulatory Affairs Manager in Multinational Pharmaceutical Company
* All submitted documents will be treated with highly confidential manner.
Thank you for your interest.

[Contact]
Tel No 82-2-555-7234
E-mail top@topheadhunter.co.kr

* 지원하시는 인재에게는 헤드헌팅 추천 서비스가 무료로 제공 되는 것으로서 어떠한 경우라도 비용이나 수수료를 받지 않고 100% 무료로 서비스를 제공하고 있습니다.
* 당사는 20년 된 국내 최고의 헤드헌팅 전문 기업으로서 진행 중 또는 프로젝트 종료 후에도 개인들이 지원한 사항이나 개인정보에 대해서는 철저한 보안이 유지되니 안심하시고 지원하셔도 됩니다.
* 인재는 (주)탑헤드헌터와 인연이 되는 순간 최고의 기업 CEO로 성장할 것입니다.

글 쓴 이: 운영자
번호
 
제 목
 
작성자
 
상태
672
  BEOL Interconnect Reliability Engineer in...  
운영자
 
진행중
671
  FAE Manager in Multinational micro-compon...  
운영자
 
진행중
670
  Regulatory Affairs Manager in Multination...  
운영자
 
진행중
669
  Head of Sales(Japan and Korea) in Multina...  
운영자
 
진행중
668
  전지개발 세파 in Multinational Energy company R...  
운영자
 
진행중
667
  전지개발 전해질 in Multinational Energy company ...  
운영자
 
진행중
666
  전지개발 음극 in Multinational Energy company R...  
운영자
 
진행중
665
  전지개발 양극 in Multinational Energy company R...  
운영자
 
진행중
664
  BMS Software in Multinational Energy comp...  
운영자
 
진행중
663
  BMS Hardware in Multinational Energy comp...  
운영자
 
진행중
662
  Cell(연료전지시스템) 수명,안전성 in Multinational Ene...  
운영자
 
진행중
661
  Cell(연료전지시스템) simulation in Multinational...  
운영자
 
진행중
660
  시스템연구개발총괄 전해질 in Multinational Energy com...  
운영자
 
진행중
659
  시스템연구개발총괄 음극 in Multinational Energy comp...  
운영자
 
진행중
658
  시스템연구개발총괄 양극 in Multinational Energy comp...  
운영자
 
진행중
 
[1[2]  [3]  [4]  [5] 
 

구인/구직 문의 | 정보보호정책 및 면책공고 | 이메일주소 무단 수집거부 | Contact Us

  (주)탑헤드헌터 ⊙사업자번호:120-86-44174 ⊙직업소개사업신고번호:강남유제2003-3220081-11-5-00043
  Rm. 3304,33rd Fl., 27th Fl., Korea World Trade Center, 159-1 Samseong-Dong, Gangnam-Gu, Seoul, Korea 135-729
  대표이사:서만식 Tel : +82-2-555-7234 FAX : +82-2-561-1441 E-Mail:top@topheadhunter.co.kr
고정