As a Regulatory Affairs Specialist, you will be responsible for coordinating and supervising Regulatory Affairs applications related to Product Life Cycle Management (LCM) and/or New Drug Approvals (NDA) in West and Central Africa and provide support as required for Middle Africa. Develop, review and update labelling and ensure RA compliance in promotional material according to local legislation and Standard Operation Procedures (SOPs).
- Monitor the regulatory environment and ensure compliance. Interact constantly with Health Authorities (HAs) to ensure timely submissions, track approvals, detect regulatory trends, and keep up to date with legislation at the affiliate. Maintain close interaction with local external stakeholders through an active presence in pharmaceutical associations and similar forums.
- Coordinate and supervise Regulatory Affairs applications related to NDA and LCM. Assess registration files, ensuring compliance of file content to regulatory requirements. Handle HAs or agents’ requests and demands on quality, clinical and non-clinical information according to NNAS standards/SOPs.
- Provide regulatory support and insight to key stakeholders. Contribute to shaping Novo Nordisk’s position on local HA proposals and guidance to provide the company’s input on regulatory initiatives. Help Affiliate RA manager to disseminate intelligence to relevant groups within Regulatory Affairs/CMR and other functions at a local level.
- Provide advice and recommendations to the local RA Manager at the local level on regulatory policy and applicable strategy to accelerate regulatory approvals while securing compliance. Ensure inspection and audit readiness for the RA unit in terms of archiving and documentation in place
You have a relevant academic degree, preferably in bachelor’s degree in Pharmacy or other related Pharmaceutical Sciences / biomedical sciences with a minimum of 5 years working experience as a Regulatory Affairs Specialist in a multinational company covering West and Central Africa. A Master’s degree in Pharmacy / Biomedical Sciences / Business Administration is a plus.
To qualify for the position, you must have:
- Knowledge of pertinent local regulatory affairs legislation in West and Central Africa
- Experience with regulatory intelligence activities and pharmaceutical registration databases.
- An innovating in a changing environment mindset as the position requires very fast adaptation to changes and innovations in the industry.
- and analytical skills and be capable of working in a culture of respect, teamwork, and personal responsibility.
- Fluency in written and spoken English is required.