The position will be based in Nairobi-Kenya and will directly support our East and Southern African Markets as well as the wider Middle Africa Affiliate.
The position will be on a yearly renewable Contract based on performance and will directly report to the Regulatory Affairs Manager for Middle Africa.
The Regulatory Affairs Specialist will be responsible for the following:
Coordinating and supervising Regulatory Affairs applications related to New Drug Applications (NDA) and Life Cycle Management (LCM)
• Managing NDA submissions in accordance with local regulation ensuring the files are prepared and submitted in time and as per local requirements.
• Maintaining licence to operate in affiliate by timely management of renewals and LCM activities including Additional Manufacturing Sites submissions and approvals.
• Coordinating actions effectively and proactively with other functions to support product launches, LCM activities and supply in due time.
• Update the various databases on submissions and approvals as received.
Monitoring the regulatory environment and ensure compliance
• Monitoring regulatory environment and ensuring full compliance with relevant legislation and with internal SOPs.
• Interacting constantly with Health Authorities (HAs) detecting regulatory trends and keeping up to date with legislation at affiliate.
• Maintaining close interaction with local external stakeholders through an active presence in pharmaceutical associations and similar forums.
• Proactively sharing regulatory intelligence with internal stakeholders on competitors’ products as well as on emerging regulations.
Provide regulatory support and insight to key stakeholders
• Contributing to shaping Novo Nordisk’s position on local HA’ proposals and guidance to provide company’s input on regulatory initiatives.
• Maintaining fluent interaction with pharmaceutical associations and key regulators to reinforce Novo Nordisk’s presence locally.
• Ensuring inspection and audit readiness for RA unit in terms of archiving and documentation in place
• Support internal stakeholders with key processes e.g. but not limited to Logistics/PS, PV, marketing and Medical.
To qualify for the position, you must have:
• Minimum 3 years of experience in the pharmaceutical industry, preferably in Regulatory Affairs.
• Bachelor’s degree in Pharmacy or other related Pharmaceutical Sciences.
• Knowledge of pertinent local legislation.
• Experience with regulatory intelligence activities and pharmaceutical registration databases.
• 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.
Working at Novo Nordisk
At Novo Nordisk we recognise that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and the communities we operate in.
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. We are happy to discuss flexible working, depending on the role and subject to business needs.
To submit your application, please upload your CV and motivational letter online (click on Apply and follow the instructions).
21st November 2021
Millions rely on us
To work for Novo Nordisk, you will need the skills, dedication, and ambition to change lives for the better for millions of patients living with diabetes and other chronic diseases. In exchange, we offer the chance to be part of a truly global workplace, where passion and engagement are met with opportunities for professional and personal development
To apply for this job please visit career2.successfactors.eu.