Responsibilities: 

• Author documents in D2 format from local formats for SCP (Regulatory and quality documents required for Health Authority submissions).
• Issue PCF in Product Data Management (PDM) platform.
• Perform technical evaluation and submission of CTD Modules as needed.
• Provide technical/regulatory support in collaboration with relevant company functions.
• Interact with regulatory authorities and relevant corporate functions.
• Update systems (Trackwise, D2) and maintain local and corporate databases.

Requirements: 

• Bachelor’s degree in Science or Pharmaceutical Sciences.