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
Although it is not possible for us to respond to all applications, we at PE Global will do our upmost to give you feedback on your application. You have sent your Cv into us as a company and even though you have sent your CV to a particular position, we are making the reasonable assumption that you are active on the job market and as part of our normal recruitment service we will discuss other suitable positions with you. You are free to opt out of this so please specify in your application to us if you just want to be contacted in relation to a specific vacancy. Your Cv is sent to a central recruitment inbox which a number of people in the applicable PE Global division have access to and so this means that you might not be contacted by the named person in this advert.