Regulatory Affairs Associate (FTC)

Summary

• Contributes and support the development of submission of product registration, progress reports, supplements, amendments, and/or periodic experience reports. Supports all registration activities of the Department to ensure compliance with the requisites of the local pharmaceutical regulatory environment.
  
  

About The Role

Major accountabilities:

• Achieve the best product registration with commercially attractive labelling in accordance with registration plan -Maintain and secure product license in terms of CMC/CDS/safety update according to local regulations/law/guidelines, company strategy and global compliance -Ensure compliance with Fuse, BeSure, code of conduct, relevant regulations and laws for related CPO activities (DRAGON update, RMP, packing materials, promotional materials/activities, drug safety reporting etc.) -Foster and maintain good relations with internal and external stakeholders. Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt
  
  

Minimum Requirements

Registered with the SAPC. Min BPharm Degree

Work Experience

• Regulatory experience min 3-5 years. Able to create and submit eCTDs.
• Functional Breadth.
• Cross Cultural Experience.
• Operations Management and Execution.
• Project Management.
  
  

Skills

• Analytical Skill.
• Collaboration.
• Detail Oriented.
• Lifesciences.
• Project Planning.
• Regulatory Compliance.
  
  

Languages

• English.
  
  

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