Apply
Irfa******
-
Kenya
-
Last Update: 14.12.2018 at 12:00
Job Type
Full Time
Start
ASAP
Duration
11 Month +
Place
Nairobi, KE
Country
Kenya
Category
Research & Development (R&D)
Description
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.