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Regulatory Affairs Specialist

PHARMASTARS
Heliopolis, Cairo
PHARMASTARS logo

Regulatory Affairs Specialist

Heliopolis, CairoPosted 2 months ago
94Applicants for1 open position
  • 32Viewed
  • 3In Consideration
  • 17Not Selected

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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