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Job Description
- For assigned products, ensures timely preparation, submission, and appropriate follow-up of new Marketing Authorization applications to the local authorities.
- Ensure the company’s products comply with the regulation of the MOH.
- Ensures that the company strictly follows government rules and regulations.
- Excellent understanding of the pharmaceutical industry, drug development environment, and company processes and objectives.
- Secures for assigned authorized products timely submission and follow-up of variations, renewal applications, and supplemental marketing authorizations.
- For assigned products ensures timely, accurate and compliant labeling translations and artwork preparation.
- Ensures permanent compliance to local regulatory requirements, policies and procedures.
- Perfectly achieving given timeline to accelerate the registration process and solving any problem in new or registered products.
- Collects relevant publicly available regulatory information (regulatory intelligence) and keeps relevant persons appropriately informed.
- Maintains a positive relationship with internal and external regulatory contacts
- Works in cross-functionality with all local departments: Markets access, Business, Finance, Medical, etc.
- Updates and implements local regulatory procedures in a timely manner, in close synergy with the Regional organization.
- Plans and tracks all regulatory actions to document and ensure full compliance with relevant legislation and with internal procedures.
Job Requirements
- 8-10 years’ experience in registration.
- Previous dealing with MOH, NODCAR and CAPA .
- The candidate should have bachelor’s degree in pharmacy or Vet.,.
- Fluent in English.
- Problem-solving and communication skills.
- Precise, accurate and analytical method of thinking (critical thinking).
- Should own car.
- Cairo resident.
- Location:- Sheraton El Nozha ,Heliopolis.
