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Job Description
- Planning and Monitoring of the Regulatory Context
- Registration of new 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 pharmacy, sciences or veterinary
- 5 Years at least of experience in a similar position
- Residence near Heliopolis
- 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 & adherence to company internal SOPS & compliance standards promptness in deliverable & in response to authorities’ requirements.
- Understand the link between own priorities & the organization.
- CTD & E-CTD