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Job Description
- Collect and coordinate information and prepare regulatory documentation for submission to regulatory agencies or to commercial partners, advise on the submission strategy
- Timely compile materials for license renewals, updates and registrations
- Maintain regulatory files/database and chronologies in good order.
- Establish and maintain system for tracking changes in documents submitted to agencies or partners
- Responsible for all steps of Research issues
- Responsible for preparation of Registration files for any new product.
- Responsible for Registration pharmaceutical products
- Responsible for following steps of formulations and stability study of any New products.
- Responsible for execution of Damaged and Expired products
- Responsible for getting Release permeation for any Shipment Responsible for following the Certificates
Job Requirements
- Pharmacies BG
- At least 2 years of relevant experience within the regulatory affairs discipline
- Relevant product and industry knowledge
- Key Competencies
- Excellent written and verbal communication skills organization and planning
- Problem analysis and problem-solving
- Persuasiveness, adaptability, judgment, decision-making, stress tolerance & collaboration
