At Novo Nordisk, we are driving change to defeat diabetes and other serious chronic conditions.
Novo Nordisk is a global healthcare company with more than 90 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat other serious chronic conditions: haemophilia, gr...
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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.
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