Regulatory Affairs Specialist.
Regulatory Affairs Specialist, Senegal
Category: Reg Affairs & Safety Pharmacovigilance
Location: Dakar, Dakar, KE
Are you highly motivated by being able to make a difference to improving patients’ lives? Are you a high performing executive who energized by challenges and able to energize people around you? Apply today and join us for a life-changing career. Be part of the game-changing organization!
This position is based in Dakar, Senegal.

The position
As a Regulatory Affairs Specialist, you will ensure products can be placed on the market with optimal yet compliant claims, and promotion in line with commercial plans, and ensure products are maintained and meet internal and external compliance requirements. Assist in securing regulatory approval of new products as planned for Middle Africa and maintain registration for existing products in due time as applicable while ensuring the flow of local regulatory process.
You will be coordinating of Regulatory Affairs applications related to New Drug Applications (NDA) and Life Cycle Management (LCM) in WCA region. You will develop, review and update labelling and ensure RA compliance in promotional material according to local legislation and Standard Operation Procedures (SOPs).

The role tasks include but are not limited to:
• Coordinate, compile and Dispatch Regulatory Affairs applications related to NDA and Life Cycle Management.
• Monitor the regulatory environment and ensuring compliance.
• Provide regulatory support and insight to key stakeholders.
• Internal and External Collaboration with Local, Regional and Global Regulatory, Pharmacovigilance, Marketing, Medical, Supply Chain, QA/QC, Technical Operations, Manufacturing and Health Authorities.

Qualifications
• University Degree University degree in Pharmacy or Pharmaceutical related studies.
• Minimum 2 years of experience in regulatory affairs.
• Knowledge of local pharmaceutical legislation. Regional legislation awareness desirable.
• Strong negotiation skills.
• Good understanding of compliance.
• Fluent French and English.


About the Department
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.

Working at Novo Nordisk
We are a proud life-science company, and life is our reason to exist. We’re inspired by life in all its forms and shapes, ups and downs, opportunities, and challenges. For employees at Novo Nordisk, life means many things–from the building blocks of life that form the basis of ground-breaking scientific research, to our rich personal lives that motivate and energise us to perform our best at work. Ultimately, life is why we’re all here – to ensure that people can lead a life independent of chronic disease.


Contact
Please click on ‘apply now’ to submit your resume in English.
Deadline

27 April 2025
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk we recognize 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 communities we operate in. Together, we’re life changing.