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Regulatory Affairs Senior Specialist

Julphar · Ras Al Khaimah

Senior 🇬🇧 English
MS Office Adobe Pro CTD eCTD

Job description

About the role

Julphar is seeking a Regulatory Affairs Senior Specialist to lead the compilation and submission of new registration dossiers across multiple markets, ensuring compliance with health authority requirements.

Key responsibilities

  • Compile and submit new registration dossiers to target countries according to the registration plan.
  • Respond to queries from health authorities and provide appropriate documentation to obtain approvals.
  • Identify documentation gaps during dossier preparation and coordinate with internal departments to resolve them.

Required profile

  • Bachelor’s degree in Pharmacy or Science with a minimum of 4 years of relevant experience.
  • Proficiency in MS Office and Adobe Acrobat Pro.
  • Strong scientific and technical knowledge of dossier compilation in CTD and eCTD formats.

Required skills

  • MS Office
  • Adobe Pro
  • CTD format
  • eCTD format

Questions fréquentes

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Published 3 weeks ago

Expires 1 month from now

31 views · 0 interested

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Julphar

Ras Al Khaimah