Responsible for supporting activities that initiate and maintain international product approvals for Wave 2b and 3 countries.
• Partnering closely with other members of the Strategy Implementation Group, Dossier Excellence, Regional Portfolio Leads and Regulatory Operations teams.
• Provides support for Wave 2b and 3 market registrations and license renewals.
• Providing documentation to support international registration and tender requests.
• Prepares responses to questions and requests from health authorities for product registrations.
• Managing a significant amount of proprietary information in a confidential manner to prevent loss of intellectual property.
• Ensures compliance with regulatory agency regulations and interpretations
• Provides solutions to a variety of problems of moderate scope of complexity.
• Maintains and archives all regulatory documentation.
Required Skill set
- Excellent written and oral skills
- Result driven
- Excellent social skills
- Teamplayer
- Able and willing to work in a complex organization with highly detailed rules and regulations
- Computer literate
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