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Regulatory Intern - MITG

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Office Support
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180004ZW Requisition #

PURPOSE:

Working with the RA Specialist to provide assistance in the preparation of submissions to Regulatory bodies for initial registrations, variations and responses to queries to achieve approval.

ROLE OVERVIEW:

Support regulatory objectives to ensure product meet SSA regulatory requirements for product approval.

MAIN JOB DUTIES/RESPONSIBILITIES

Regulatory Submission Support
  • Work on Projects related to regulatory compliance in SSA.
  • Participate in multidisciplinary project teams to present regulatory guidance and communicate regulatory goals.
  • Assist with the organization of regulatory documents and correspondence
  • Monitor newly published regulatory guidelines and guidance document on the context of new and ongoing development programs within SSA
  • Communicate with regulatory bodies, health authorities and other stakeholders within SSA for assigned projects.

KNOWLEDGE/EDUCATION                                                                                                                
  • Undergraduate degree in pharmacy and related life sciences discipline is required.
  • Excellent communication (written and verbal) and strong interpersonal skills.
  • Results-driven; excellent attention to detail.
  • Good problem-solving and analytical skills.
  • Strong project management skills; able to manage multiple priorities.
  • Ability to work independently.
  • IT skills, particularly in relation to using databases.
 
SKILLS/COMPETENCIES
  • Honest and ethical
  • Must be computer literate at an intermediate level:
 

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