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.
BSc Degree in Pharmacy or related field2 - 5 Years of experience as Regulatory Affairs Specialist in human pharmaceutical CompaniesUp to date with all current laws in Regulations, Guidelines, EDA electronic Platform.Good business relationships in different departments of EDARegulatory Documentation and Regulatory Submissions skillsExperience 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 skillsAttention to detail and strong analytical skillsExcellent organizational and administrative skillsAbility to work independently and as part of a teamperform effectively and able to meet deadlines. Good Computer Skills (MS Office – Internet browsing)Good English and Arabic (Written & Spoken)