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.

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.