Regulatory Affairs Senior Specialist At Delta Pharma
About the job
Do you have a passion for our challenging role as Regulatory Affairs Senior Specialist? Would you like to have an impact on our patient’s lives in a company that strives to help patients at scale and speed? Then Pharaonia Pharmaceutical might be the one for you!
About Delta
Delta Pharma is a leading pharmaceutical company in the Egyptian market aiming to step up its rank among all other Arabian pharmaceutical manufacturers, to become one of the top ten generic companies in the region within the upcoming years.
What You’ll Do
- Presents the new products to the marketing department for study.
- Prepares the annual and semi-annual registration plan with the export section for the required products to be registered.
- Searches for procedures for registering the products in the concerned country.
- Prepares and processes the product file for registration.
- Submits the documents required to register the factory in the importing country according to the laws of each country.
- Determines dates for external inspection visits from the importing countries.
- Submits files (registration - pricing) to central administration for pharmaceutical products and the concerned country and follows up on the steps after submission.
- Submits a petition in the event of any decision impeding registration or inappropriate pricing.
- Follow-up issuance of approval for the product and obtain the final notification from the central administration for pharmaceutical products. (Final Notice - Temporary Notice)
- Prepares a trial batch to study the stability and add it to the product file.
- Submits the stability file on the specified date in central administration for pharmaceutical products - the stability department.
- Submits the required documents in the event of a change to any product.
- Applies to the Department of Approved Bulletins and notifies the specialists in issuing product pamphlets of the requirements of the central administration for pharmaceutical products.
- Ensures that the customer receives the initial approvals and starts the first batch.
Applicants should possess the following qualifications to go through initial screening:
- Bachelor of Pharmacy, Science, or Vet
- 3-5 Years of experience in a similar position (Preferable Export Experiences and Local Background)
- Computer skills
- Good Command of the English Language
- Knowledge of new decrees & Guidelines
- Result Oriented
- Attention to Details
- Team player
Apply now: Careers@dp.eg