Senior Regulatory Affairs Specialist

Delta Pharma Egypt - Heliopolis, Cairo

84
Applicants for
1 open position
54
Seen
18
Shortlisted
37
Rejected
Experience Needed:
3 to 5 years
Career Level:
Experienced (Non-Manager)
Job Type:
Full Time
Salary:
Confidential, Confidential, Annual profit share-Social & Medical insurance and other allowances
Languages:
English
Vacancies:
1 open position
About the Job
  • Planning and Monitoring of the Regulatory Context
  • Registration of new products & re-registration of current products
  • Maintain and update labeling & variations
  • Carry out the planned RA Activities e.g. Pack Size Additions, Artwork Approvals
  • Preparation & submission of BE files with follow up with the third party center and Health Authority
  • Assure compliance with IA files
  • Price Preparation, submission & follow up of files and documents in the required Timelines.
  • Following and complying with all the defined internal policies and procedures of working.
  • Strictly following all the Authority Regulations, decisions & decrees.
Job Requirements
  • Bachelor of pharmaceutical / Sciences
  • 3-5 Years of experience in a similar position
  • Computer skills, Negotiation & Communication skills.
  • Good Command of English Language
  • Organization skills and high accuracy in documentation
  • High sense of urgency
  • Knowledge of new decrees & Guidelines
  • Time management
  • Awareness & adherence to company internal SOPS & compliance standards promptness in deliverables & in response to authorities’ requirements
  • Understand the link between own priorities & the organization.
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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