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Job Description
- Registration/ Re-registration/ Variation/ Inquiries of company products throughout their life-cycles including preparation the files in CTD / E-CTD format & submission of regulatory documentation to different authorities in different countries within the specified time-frame, negotiation & effective communication to obtain timely product approvals.
- Keeping international legislation, guidelines & costumer practices in all countries that the company is exporting to.
- Expertise proficiency with software tools & metrics for E-CTD submission.
- Preparation/ Revision the PIL (Patient Information Leaflet) & the SPC.
- Preparation of BE files with follow up with the third party center & health authority.
- Assure compliance with IA files.
- Price preparation, submission & Follow up of files & documents in the required timelines.
- Following & complying with all the defined internal policies & procedures of working.
- Strictly following all the Authority Regulations, decisions & decrees.
Job Requirements
- B.Sc. in Pharmaceutical science.
- From 6 to 9 years of experience in RA.
- Very Good English.
- Computer Skills.
- Organization skills & high accuracy in documentation
- problem solving abilities.
- Good command of most applications.
- High sense of urgency.
- Knowledge of new decrees & guidelines.
- Time Management.
- Awareness & adherence to company internal SOPs & compliance standards promptness in deliverable & in response to authorities requirements.
- Understand the link between own priorities & the organization ambition.
- CTD & E-CTD.
