• 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.
• Managing Team Of regulatory affairs Specialist
• Experiences in dealing with All Authorities of Registration of Pharmaceutical , Medical devices and Herbal products
• 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.
• 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.

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.

If you Matching Above Criteria , Kindly forward your resume to Talent.Aqu.eg@gmail.com within 15 days – All Resume will be confidential