Regulatory Affairs Specialist

7 days ago

Heliopolis, Cairo, Egypt Delta Pharma Full time 40,000 - 80,000 per year

Key Accountabilities:

  • Prepare and submit
    export & local
    documentation to regulatory authorities.
  • Ensure compliance with international regulations, including FDA, EMA, and other relevant agencies.
  • Collaborate with internal teams to gather necessary information for regulatory submissions.
  • Monitor changes in
    export & Local regulations
    and assess their impact on the company's products.
  • Provide guidance on regulatory requirements for product registration in foreign markets.

Qualification Requirements:

  • Bachelor's degree in Pharmacy or a related field.
  • Experience from 1 to 3 years.
  • Must have Experience/Knowledge in
    CTD
    file preparation for
    Export
    .
  • Proficiency in spoken and written English.
  • Good organizational and communication skills.
  • Negotiation and teamwork abilities.
  • Time management and planning proficiency.
  • Presentation, creativity, and innovation skills.
  • Responsibility and adaptability.

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