Regulatory Affairs Associate
(2 years contract)

[Job Description]

• Mainly responsible for checking and ensuring regulatory compliance of registered pharma portfolio by reviewing global registration dossier and local registrations for the products and substances
  
  
• Manage planning and execution of regulatory activities related to the review and check of regulatory compliance of registered products in compliance with global standards and local regulations
  
  
• Ensures regulatory compliance for a sustainable life-cycle management when assigned: manage labeling and CMC changes in accordance with local regulations and relevant global SOPs
  
  
• Provide regulatory gap analysis and risk mitigation plan, timely communicate to local & regional RA management in relation to regulatory compliance checking. 
  
  
• Review and approve packaging texts to ensure compliance with registration and legal requirements. 
  
  
• Maintain global regulatory databases accordingly, and archive registration dossier of assigned portfolio in accordance with global and local SOP. 
  
  
• Monitor and timely communicate upcoming regulation or policy changes for assigned area including preliminary impact analysis. 

[Qualifications / Requirement]

• Life Sciences based BS or MS with requisite experience and demonstrated track record.
  
  
• Preferably more than 3 years’ experience in regulatory or drug/biologic development experience in pharmaceutical industry.
  
  
• Good in English and ability to communicate effectively both orally and in writing, adaptable to changing environment, with proven persuasive, assertive and negotiating skills. Good cross-functional communication skills.
  
  
• Knowledge of local regulatory framework, compliance aspects related to regulatory affairs function and other relevant country requirements applicable to pharmaceuticals and medical devices is desired.

[근무조건]

근무 형태: 계약직(2년)

급여: 회사내규에 따름

[문의사항]

 전화: 02 - 829 - 6511
 E-mail: yeonsoo.kim@bayer.com

[기타 안내사항]