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Job Description
- Compile and maintain regulatory documentation databases or systems.
- Coordinate efforts associated with the preparation of regulatory documents or submissions.
- Analyze product complaints and make recommendations regarding their re-portability.
- Develop or conduct employee regulatory training.
- Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review
- Submit and follow up stability files
- Submit and follow up Nodcar files
- Submit and follow up Bioequivalence files
- Submit and follow up pharmacology & naming files
- Submit and follow up variation files
Job Requirements
- Bachelor of pharmaceutical sciences
- 3-5 Years of experience in a 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
