Regulatory Specialist at Novo Nordisk

The Position

Do you perform best where change is daily and the unexpected is a routine? Do you wish to make a difference?. If yes, you have an opportunity to be part of the Novo Nordisk Middle Africa Regulatory Affairs team, which is responsible for effective execution of Novo Nordisk regulatory strategies across countries in Africa.

Yes, we are looking for a “Regulatory Specialist” based in Nairobi (Kenya).

Responsibilities

Securing regulatory approval of new products (NDA), Maintain registration for existing products in due time, Ensure the flow of local regulatory process across the region, Coordinate and supervise regulatory applications related to product Life Cycle Management (LCM), Develop and update labelling in compliance with the local regulatory requirements, Ensure regulatory compliance in promotional material according to local legislation and Standard Operation Procedures (SOPs), Monitor the current regulations and updates across countries in Africa that are potentially impacting Novo Nordisk & ensure timely implementation.
Assist in implementation of Novo Nordisk Quality Management System (QMS), ensuring product quality, focus on business critical issues that may have an impact on license to operate, ensure inspection readiness and assist in Pharmacovigilance activities across Middle Africa.

You have a proactive and solution oriented approach to the challenges with logical reasoning, Adaptable and flexible with ability to multi task and deliver results, Good negotiation, collaboration and stakeholder management skills and a Good team player.

Qualifications

We expect you to hold a Bachelor of Pharmacy, BSc degree (e.g. in Pharmacy or pharmaceutical related studies). You are fluent in written English and French languages. You have minimum 3 years of experience in pharmaceutical industry, 2 (two) year experience in the Regulatory as a RA associate. You have the knowledge of local regulations and regional legislation across countries in Africa. If you have working knowledge in the area of Quality Assurance and Pharmacovigilance it will be an advantage.
Working at Novo Nordisk

At Novo Nordisk, we strive for excellence. You share the same passion and commitment as our employees in our journey to make a difference to patients’ lives. In exchange, we offer you the chance of a lifetime to work with extraordinary talent and benefit from unmatched opportunities for professional and personal development.

Contact

If you are interested in the challenging and rewarding position posted above, please apply via www.novonordisk.com/jobs. CVs sent to e-mail account will not be taken into consideration; only the applications received at the jobs site are reviewed.

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 chronical 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.