Novo Nordisk recrute 01 spécialiste des affaires réglementaires
Category: Regulatory
Location: Dakar, Dakar, SN
Are you interested in improving the lives of millions of people, working in a company that works with innovation and is a leader in diabetes? Join us and become a Regulatory Affairs Specialist in Novo Nordisk Senegal.
Novo Nordisk is a global healthcare company with more than 95 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat obesity, haemophilia, growth disorders and other serious chronic diseases.
Headquartered in Denmark, Novo Nordisk employs over 45,000 people in 80 countries, and markets its products in more than 169 countries.
About the department
Novo Nordisk is looking for a motivated and well-rounded person to take up the role of Regulatory Affairs Specialist for Middle Africa (MA) on Contract basis till end of 2022 that can be renewable based on performance. This person will support the implementation of Regulatory Affairs strategy and drive Regulatory Affairs activities across Middle Africa in compliance with Novo Nordisk and local regulatory requirements.
Novo Nordisk Middle Africa Affiliate
The Novo Nordisk Middle Africa Affiliate 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 people living with diabetes.
The position will be based in Dakar (Senegal) and the person will directly report to the Regulatory Affairs Manager.
The position
The Regulatory Affairs Specialist will be responsible for the following:
Diabetes Finished Product (DFP) and Biopharm Manufacturing Sites Project:
- Preparation of Additional Manufacturing Sites/Change in manufacturing Sites packages, Dispatch to the agents for submission and follow up for approval with the Health Authorities.
Update the DFP and Biopharm Project Team on the status of the various submissions and challenges faced if any.
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.
- Coordinating actions effectively and proactively with other functions to support product launches, LCM activities and supply in due time.
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 in order to provide company’s input on regulatory initiatives.
- Maintaining fluent interaction with pharmaceutical associations and key regulators in order to reinforce Novo Nordisk’s presence locally.
- Ensuring inspection and audit readiness for RA unit in terms of archiving and documentation in place
Qualifications
To qualify for the position you must have:
- Minimum 3 years’ experience in the pharmaceutical industry.
- Minimum 1 year experience in Regulatory Affairs as a Regulatory Affairs Associate.
- 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 and French.
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.
Contact
To submit your application, please upload your CV online (click on Apply and follow the instructions).
Preference will be given to candidates from the designated groups as prescribed by Section 15 of the Employment Equity Act, No. 55 Of 1998.
Millions rely on us
At Novo Nordisk, we don’t wait for change. We drive change. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. Working at Novo Nordisk is working toward something bigger than ourselves, and it’s a collective effort. Novo Nordisk relies on the joint potential and collaboration of its more than 40,000 employees to change the lives for the better for millions of patients living with diabetes and other chronic diseases. Together, we go further. Together, we’re life changing.
Deadline: 13/10/2021