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Job Description
Medisave pharma for pharmaceutical industries, one of the fast growing well established pharmaceutical companies located in New Cairo, Egypt; is hiring “Drug Regulatory Affairs Specialist”.
What We offer:
- Attractive Package.
- Flexible Work Environment.
- Social & Medical Insurance.
- Fast Growing Career Path.
- Rewarding Compensation and Benefits plan.
Responsibilities:
- Prepare the registration application files in accordance to the local regulations (AW, claims, and technical files) to present to EDA or in Foreign countries
- Follow up submission and any supporting documents along with registration lead time.
- Ensure that Products Claims are complied with local MOH regulations and legal requirements.
- Follows up with the application deadline and gathers the required documentation from Country of origin.
- Arranging and dealing with the Supply planner regarding all new and updated products while adhering to regulatory Lead-time.
- Completing all registration requirements for all shipments at EDA.
- Administer all transfers and requested process to ensure smooth transactions for all overseas goods and maintain financial accuracy, and approval of regulatory cost as per invoice.
- Maintain knowledge on all rules and regulations of import processes and ensure efficient transmission of all import & local goods.
Job Requirements
- Bachelor’s degree in pharmacy.
- 2-4 years of experience.
- Knowledge of EDA regulatory affairs is a must.
- Experience mainly in pharmaceutical “pharmaceuticals products & cosmetic products” regulatory and submissions in CAPA, NODCAR.
- Good knowledge of preparation of registration files.
- Excellent command of English and Arabic
