Regulatory Affairs Section Head (Exportation)

Delta Pharma Egypt - Cairo, Egypt

Applicants for
1 open position
Experience Needed:
4 to 9 years
Career Level:
Experienced (Non-Manager)
Job Type:
Full Time
1 open position
About the Job
  • 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.
About this Company

Delta Pharma actually put the people health as a part of its strategy as People health is the Delta Pharma concern , every one can touch these words & can interact through the wide range of product categories supporting from pain to depression remedies , looking for the... (More)

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