Regulatory Officer - Saudi

Pharmaceutical Solutions Industry Ltd "PSI"; Jeddah; On-site; SAR 200,000 - 300,000; Full time

Job summary

A leading pharmaceutical company in Jeddah is seeking a Regulatory Officer to prepare registration files and manage submissions to regulatory authorities. The role involves writing and editing technical documents, compiling dossiers, and overseeing compliance activities. Candidates should have a Bachelor's degree in a science-related field and 1-3 years of experience in regulatory activities. Strong analytical skills and excellent communication are essential. This position is crucial for facilitating the registration of pharmaceutical products in the region.

Qualifications

• 1-3 years of experience in regulatory activities (pharmaceutical).
• Ability to digest complex data while keeping the big picture.

Responsibilities

• Prepare registration files for SFDA, GCC & Regulatory Authorities.
• Write and edit technical documents for regulatory submissions.
• Compile dossiers for submission to Health Authorities.
• Handle registration-related queries and responses.
• Review raw materials and finished product specifications.
• Maintain registration documents and follow up with departments.

Skills

Scientific knowledge

Excellent written and verbal communication

Technical system skills

Project Management skills

Analytical skills

Education

Bachelor’s degree in Science (Chemistry, Biomedical Science, Microbiology, Pharmacy)

Tools

MS Office applications

Databases

Job description

Regulatory Officer

Preparing registration files of PSI products for SFDA, GCC & Regulatory Authorities in export countries

RESPONSIBILITIES

• Write, analyse, and edit technical documents to support country-specific regulatory submissions.
• Compile and prepare dossiers (CTD/eCTD) of finished products for submission to SFDA and other Health Authorities.
• Apply the eCTD in registration renewal and variations during the life cycle of assigned products.
• Handle registration-related queries and process responses to SFDA and other Health Authorities through eCTD.
• Review of raw materials and finished product specifications for Pharmacopeial compliances (USP/BP/Ph.Eur).
• Maintenance of Registration documents.
• Follow up with the concerned PSI departments (QC, QA, Marketing, Manufacturing, R&D, etc.) through the registration supervisor for successful submission of the dossier and timely availability of documents for submission.

Education

Bachelor’s degree in Science (Chemistry, Biomedical Science, Microbiology, Pharmacy)

Experience

1-3 years of experience in regulatory activities (pharmaceutical)

Job-related Skills

• Scientific knowledge, must be able to digest complex data while keeping the big picture through good analytical skills.
• Excellent written and verbal communication skills with the ability to listen.
• Technical system skills (e.g.: MS office applications, databases, efficient online research)
• Project Management skills.
• Ability to identify compliance skills and elevate when necessary.