Regulatory Affairs Associate (2 years contract)

Your tasks and 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.