Regulatory Affairs Section Head (Exportation)

Delta Pharma Egypt - Cairo, Egypt

55
Applicants for
1 open position
52
Seen
8
Shortlisted
43
Rejected
Experience Needed:
4 to 9 years
Career Level:
Experienced (Non-Manager)
Job Type:
Full Time
Salary:
Negotiable
Languages:
English
Vacancies:
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 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.

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