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Job Description
- Prepare , submitting and follow up registration documents for NAFSA .
- Implementing the regulatory activities and ensures compliance with applicable guidelines and SOP.
- Preparing, submitting and following up Registration documents of under-registered, registered & re-registered products to the EDA and related parties to ensure the availability & maintenance of the product in the market
- Complete renewal & exist products’ registration process at EDA .
- Provides direct assistance with the registration of new and existing products in markets supplied by the plant.
- Prepares and submit files and reports to related regulatory authority.
- Coordinate & follow all steps of registration in EDA (Egyptian Drug Authority) including Stability Study, Bioequivalence Study, Inserts, Packs and NODCAR files till approval
- Follows up batches and raw material submitted samples for analysis till receiving conformity.
- Implement and follow up any variations needed in any product such as change in pack, formula …….etc.
- Submit and Follow up and any supporting documents along with registration lead time.
- Track the application deadline updates and gathers the required documentation from related parties.
- Coordinate & collaborate with the R&D, Q.C, Production, Marketing team members
- Communicate regulatory information to multiple departments
- Maintains current knowledge of updated regulatory guidelines.
- Establish and maintain professional relationships with the internal and external stakeholders.
- Implement and maintain registration tracking system for publishing document submissions either in hardcopy or electronic formats.
- Resolve or follow up complaints to ensure effective and timely resolution of all complaint investigations.
- Notifies direct manager when compliance issues arise or are identified, when regulatory reports are delayed, and when other immediate action is required.
- Archiving all documents, licenses and letters.
Job Requirements
- Bachelor’s degree in any pharmacy, or veterinary
- Good command of English language (written and spoken)
- Proven experience in Regulatory affairs with min of 5 to 7 years’ experience in pharma industry
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