Regulatory Affairs Senior Specialist – CTD/eCTD Dossier

Julphar; Ras Al Khaimah; On-site; AED 100,000 - 167,000; Full time

Job summary

Julphar in the UAE is seeking a Pharmacy/Science graduate with 4+ years experience to lead registration dossiers in CTD/eCTD formats. You will compile submissions and coordinate with health authorities worldwide, ensuring accuracy and timeliness.

The role requires strong English communication, meticulous documentation, and collaboration across departments to close gaps and ensure compliance with ISO 14001:2015 and HSE policies.

Qualifications

• Bachelor of Pharmacy/Science with at least 4 years of experience.
• Proficient in MS Office and Adobe Pro.
• Strong knowledge of CTD and eCTD dossier compilation.

Responsibilities

• Responsible for compilation and submission of new registration dossiers to respective countries as per the registration plan.
• Handle the queries by providing the appropriate responses, as it is required to get the approvals from the health authorities of different countries.
• Evaluation and identification of documentation gaps during the dossier compilation and communicating with the respective department to fulfil requirements.

Skills

Dossier compilation

CTD/eCTD knowledge

English communication

Regulatory awareness

Education

Bachelor of Pharmacy / Science

Tools

MS Office

Adobe Pro

Job description

Julphar in the UAE is seeking a Pharmacy/Science graduate with 4+ years experience to lead registration dossiers in CTD/eCTD formats. You will compile submissions and coordinate with health authorities worldwide, ensuring accuracy and timeliness.

The role requires strong English communication, meticulous documentation, and collaboration across departments to close gaps and ensure compliance with ISO 14001:2015 and HSE policies.