Novo Nordisk is looking for a motivated and well-rounded person to take up the role of Regulatory Affairs Manager for Middle Africa. This person will develop and implement Regulatory Affairs strategy and drive Regulatory Affairs activities across Middle Africa in compliance with Novo Nordisk and local regulatory requirements.The JobThe Regulatory Affairs Manager will be responsible for the following:
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.
Ensuring submission of safety reports from Middle Africa to the respective country Health Authorities in compliance with the local requirements.
Exploring and developing new ways to improve operational efficiency for Regulatory Affairs activities, especially reducing time to complete physical dossiers and right first-time approval with all relevant authorities.
QualificationsTo qualify for the position you must have:
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.
Problem solving and analytical skills and be capable of working in a culture of respect, teamwork and personal responsibility.
Fluency in written and spoken English, French is an added advantage.
At Novo Nordisk, we use our skills, dedication and ambition to help people with diabetes. We offer the chance to be part of a truly global work place, where passion and engagement are met with opportunities for professional and personal development.Contact
If you are interested in applying for the position please apply through the Novo Nordisk
