Location:

Nairobi, Kenya

Requisition #:

180004ZW

Post Date:

Mar 29, 2018

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:

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.