Regulatory Intern - MITG
Medtronic
Nairobi, Kenya
19h ago

PURPOSE :

Working with the RA Specialist to provide assistancein the preparation of submissions to Regulatory bodies for initialregistrations, 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 communicateregulatory goals.
  • Assist with the organization of regulatory documents and correspondence
  • Monitor newly published regulatory guidelines and guidance document on the context of new andongoing development programs within SSA
  • Communicate with regulatory bodies, health authorities and other stakeholders within SSAfor assigned projects.
  • KNOWLEDGE / EDUCATION

  • Undergraduate degree in pharmacyand related life sciences discipline is required.
  • Excellent communication (writtenand verbal) and strong interpersonal skills.
  • Results-driven; excellentattention to detail.
  • Good problem-solving andanalytical skills.
  • Strong project managementskills; able to manage multiple priorities.
  • Ability to work independently.
  • IT skills, particularly in relation to usingdatabases.
  • SKILLS / COMPETENCIES

  • Honest andethical
  • Must becomputer literate at an intermediate level :
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