Regulatory Affairs associate
(육아휴직 대체 13개월 계약직)  

[Your tasks & Responsibilities]  

• Manage planning and execution of regulatory affairs activities (e.g. preparation and submission of new registration, line extension, post-approval variations) and follow through from submission to approval. 
  
  
• Provide regulatory gap analysis and risk mitigation plan, timely communicate to local & regional RA management for assigned portfolio. 
  
  
• Ensures regulatory compliance for a sustainable life-cycle management: manage labeling and CMC changes in accordance with local regulations and relevant global SOPs
  
  
• Ensure proper maintenance and update of product licenses in compliance with global standard and local regulations. 
  
  
• 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. 
  
  
• Manage regulatory activities for clinical trials based on documentations provided from global regulatory affairs and in accordance with local regulations.  
  
  
• 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 1 year's experience in regulatory or drug/biologic development experience in pharmaceutical industry.
  
  
• Good in English and ability to communicate effectively both orally and in writing, 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.