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Job Description
- 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
- Graduated from Veterinary or Pharmacy
- 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 deliverable and in response to authorities requirements
- Understand the link between own priorities and the organization ambition
- CTD & e- CTD
