Summary
Date Posted: Wednesday, October 23, 2019 , Base Salary: Not Disclosed

JOB DETAILS:
The Novo Nordisk Middle Africa business unit consists of 49 countries and was formed early in 2012. Novo Nordisk has a well-established presence in Africa with the best quality human insulin and our focus today is to sustain the growth of the market, ensure access to better quality modern insulin and newer product formulations and support the people living with diabetes. The Middle Africa management team is based in Nairobi, Kenya where the Regulatory Affairs Manager for Middle Africa will also be based. .

Job Responsibilities:
• Providing regulatory support and insight to external and internal stakeholders.
• Developing Affiliate level regulatory strategy and implementation plans (IPs).
• Leading the local Regulatory Affairs team.
• Assisting in securing timely regulatory approval of new products as planned for Middle Africa and maintain registrations and updates for existing products in due time as applicable while ensuring the flow of local regulatory process as the Health Authority Liaison.
• Developing, reviewing and updating labelling and ensuring regulatory compliance in promotional material according to local legislation and Standard Operating Procedures (SOPs).
• Monitoring the regulatory environment and ensuring compliance
• Assisting in providing input on submission information into the Regulatory Information Management System (RIMS) and ensuring that all affiliate data in RIMS is complete, accurate and provided on time.
• Collaborating with local, regional and global Regulatory, Marketing, Medical, Supply Chain, QA/QC, Technical Operations, Manufacturing and Health Authorities to deliver on regulatory commitments.

Job Skills: Not Specified

Job Qualifications:
• A minimum of 5 years Regulatory Affairs experience.
• A Bachelor’s degree in Pharmacy, must be registered as a Pharmacist with the Kenya Pharmacy and Poisons Board.
• Advanced knowledge of pertinent local regulations.
• Experience with regulatory intelligence activities and pharmaceutical registration databases.
• Previous team/people management experience.
• An innovating in a changing environment mind-set as the position requires very fast adaptation to changes and innovations in the industry.

Job Education Requirements: Not Specified
Job Experience Requirements: Not Specified

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Job application procedure
  https://www.novonordisk.com/careers/working-at-novo-nordisk/job-ad-display.20338.en_GB.html?cid=LI
click here to apply

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