Regulatory Affairs Consultant At Elanco
Position Description: Responsible for managing regulatory affairs activities in Egypt under supervision of the Regulatory manager of Egypt.
Functions, Duties, Task:
Marketing Authorizations Transfer (MAT) and Manufacturing Name Change (MNC) linked to Elanco Stallion and Bison projects in Egypt
Plan for the appropriate timelines of receiving all requested documents (legalized certificated, full dossiers & samples).
Ensure local labels created for projects meet local and corporate criteria by providing the necessary inputs and deal with the regional labeling team and plant graphic specialist.
Initial Submission and management of the new products (including product line extension and new indication registration).
Support maintenance of marketed products (including product maintenance as manufacturing or labeling variations, renewals, etc.).
Minimum Qualification (education, experience and/or training, required certifications):
Bachelor in Pharmacy/Veterinary Doctor.
Perfect Knowledge of regulations in Egypt.
Fluency in Arabic, and excellent command in English.
Additional Preferences:
Support team spirit by
Sensitivity, tolerance and listening
Collecting and sharing of information
Constructive confrontation and assertiveness