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About AbbVie

AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

RA Associate (1-year fixed term)

Seoul, South Korea Req ID 2207667 Category Regulatory Affairs Division AbbVie

PRIMARY OBJECTIVE

To assist or manage the preparation of regulatory submissions of company products in order to obtain necessary regulatory approvals

JOB SCOPE

  • Product license variations
  • Label updates (including CCDS update)
  • Artwork review
  • Support of regulatory activity    

CORE JOB RESPONSIBILITIES:

  • Ensures timely preparation of valid submissions organized and scientifically;
    - Manage registration of variations to marketed products to ensure regulatory approvals are achieved in accordance with Company objectives.
    - Coordinate responses to deficiency letters and other requests for data in agreed timelines
  • Liaise with the relevant authorities to secure regulatory approvals.
  • Maintain the registration of marketed products.
  • Review labelling and product information for compliance with relevant regulations and codes.
  • Maintain good knowledge of the relevant Regulations & Code.  
  • Liaise with operations department and others to maintain product changes and ensure these comply with regulations.
Qualifications:

EDUCATION/QUALIFICATIONS/EXPERIENCE:

  • Bachelor’s degree or equivalent i.e. degree in Pharmacy, Chemistry, Biologics or a related scientific field.
  • Preferred more than 1 year experience in pharma or medical device industry
  • Must be good at English communication

*애브비는 개인정보 보호법과 채용 절차의 공정화에 관한 법률를 준수합니다. 보내주신 이력서는 채용하는 포지션에 대한 채용 검토 목적으로만 사용되며 사용 목적이 다한 즉시 폐기합니다.

Travel: Yes, 5 % of the Time
Job Type: Apprenticeship
Schedule: Full-time
ABBVIE

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