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Regulatory Affairs Specialist

Delta Pharma

2 - 5 years Cairo - Egypt

Any Nationality


, Posted on May 16, 2018 1 Opening

Job Description

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About the Job
• Planning and Monitoring of the Regulatory Context
• Registration of new products & re-registration of current products
• Maintain and update labeling & variations
• Carry out the planned RA Activities e.g. Pack Size Additions, Artwork Approvals
• Preparation & submission of BE files with follow up with the third party center and Health Authority
• Assure compliance with IA files
• Price Preparation, submission & follow up of files and documents in the required Timelines.
• Following and complying with all the defined internal policies and procedures of working.
• Strictly following all the Authority Regulations, decisions & decrees.
Job Requirements
• Bachelor of pharmaceutical sciences
• 2-5 Years of experience in the similar position
• Computer skills, Negotiation & Communication skills.
• Good Command of English Language
• Organization skills and high accuracy in documentation
• High sense of urgency
• Knowledge of new decrees & guidelines
• Time Management
• Awareness and adherence to company internal SOPs & compliance standards Promptness in the deliverable and in response to authorities requirements
• Understand the link between own priorities and the organization ambition
• CTD & e- CTD


Industry Type : Education / Training / Teaching / Academics
Functional Area : Administration

Keywords

Pharma Research Associate Monitoring Regulatory affairs Time management Compliance Relationship Executive Business Executive Internal Auditor

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Delta Pharma


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