Job Details
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Job Description
Primary task:
Handling regulatory documentation, and regulatory affairs on a day-to-day basis including but not limited to:
- Submission and follow-up of registration & re-registration files for the company’s product.
- Preparation & Follow-up of files submission to various committees until receiving final approval.
- Review & Submission of files & samples to EDA labs ensuring sourcing of analytical requirements and following-up the analysis until receiving final conformity
- Working closely with the department manager in the process of releasing finished products, imported raw materials, imported research and development samples and imported packaging materials.
- Revising final outer and inner packs data & issuing approvals from EDA. and revising final films from printing houses.
- Pre-formulation research for new pharmaceutical products.
- Applying the company policies and work for achieving its goals according to the ethics, rules & regulations.
Secondary Task:
- Perform Basic pharmacovigilance routine tasks.
Job Requirements
- BSc Degree in Pharmacy or related field
- 2 - 5 Years of experience as Regulatory Affairs Specialist in human pharmaceutical Companies
- Up to date with all current laws in Regulations, Guidelines, EDA electronic Platform.
- Good business relationships in different departments of EDA
- Regulatory Documentation and Regulatory Submissions skills
- Experience with DMF/CTD is an asset.
- Phamacovigilance qualification & practice, together with up to date knowledge of Guideline on Good Pharmacovigilance Practice (GVP) in Egypt is an asset.
- Good desktop research skills
- Attention to detail and strong analytical skills
- Excellent organizational and administrative skills
- Ability to work independently and as part of a team
- perform effectively and able to meet deadlines.
- Good Computer Skills (MS Office – Internet browsing)
- Good English and Arabic (Written & Spoken)
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