About the Job
A new role has opened up and we are hiring a regulatory management manager to be based in Cairo/Egypt. You will act as the in-country Regulatory Representative and will be responsible from the effective management of regulatory support for our Life Science (LS) products and services in North Africa and in other strategic Middle East countries. Our products and services cover the areas of Materials Containing Animal by-Products, Medical Devices, IVDs, Electrical Equipment’s, Reference Standards, APIs, Pharmaceutical Excipients, Food Additives etc.
Your responsibilities will be to drive, manage and coordinate registration/Notification/Listing activities in North Africa and in other Strategic Middle East Countries. You ensure the start and completion of registration/notification/listing activities in correct and in timely manner and follow up the change management, final outcome, reporting and maintenance.
You build up leadership initiatives for relationship with local authorities and industry associations. Be responsible from advocacy and surveillance activities with local governmental authorities and associations.
You monitor and report on changes of relevant regulatory and compliance environment with impact to our commercial activities. Analyze available regulatory and compliance information.
Your responsibilities will be to drive, manage and coordinate registration/Notification/Listing activities in North Africa and in other Strategic Middle East Countries. You ensure the start and completion of registration/notification/listing activities in correct and in timely manner and follow up the change management, final outcome, reporting and maintenance.
You build up leadership initiatives for relationship with local authorities and industry associations. Be responsible from advocacy and surveillance activities with local governmental authorities and associations.
You monitor and report on changes of relevant regulatory and compliance environment with impact to our commercial activities. Analyze available regulatory and compliance information.
You will also ensure effective coordination of strategic activities with Subject Matter Experts, Local Regulatory Bodies and Industry Associations. Secure flow of information from/to authorities, industry associations and Life Science organization. And closely work with global/regional regulatory surveillance &advocacy team and regulatory subject matter experts to link the local advocacy activities with global/regional advocacy activities.
You will take active role to represent company in delicate or risk potential matters in regulatory agencies, inspectors and trade associations.
Job Requirements
- University degree in Pharmacy, chemistry, biology or related science/Engineering background. MSc is preferable
- Being fluent in French is a pre-requisite
- Knowledgeable of EU and local country animal by-product regulations, IVD-Medical Device, import/export regulations
- Experience of minimum 5 years in regulatory affairs with proven knowledge of laws and regulations in medical devices, IVDs, biologics etc.
- Proficient in MS Office Software (Word, Excel, PowerPoint, Project) and ERP Systems, SAP. Demonstrate good communication & project management skills.
- Ability to work in multi-cultural teams and open to travel
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