Global Regulatory Lead – API, Excipients & Packaging

Pharmaceutical Solutions Industry Ltd \"PSI\"; Jeddah; On-site; SAR 180,000 - 300,000; Full time

Job summary

Pharmaceutical Solutions Industry Ltd "PSI" in Jeddah seeks an Asst. Manager – Registration to lead the timely registration of PSI products in local and export markets. You will handle eCTD submissions to SFDA and other authorities, review data, and manage lifecycle changes.

Requires a Bachelor’s degree in Science or Pharmacy and at least 5 years’ regulatory experience in the pharma industry. This role involves close collaboration with QA, Production, and R&D teams.

Qualifications

• Bachelor’s degree in Science or Pharmacy.
• 5 years regulatory experience in pharma companies.
• Experience with SFDA submissions and regulatory processes.

Responsibilities

• Manage electronic submission of Registration Files in eCTD format to SFDA and other regulatory authorities.
• Review data in registration files prepared for submission to regulatory authorities.
• Life cycle management of PSI products per SFDA and export regulations.
• Maintain registration archives and ensure licenses and labeling are up to date.
• Check applications for SFDA market on the eSDR site.
• Coordinate with Q.C, Q.A., Production, and R&D for data gathering.
• Review documents for APIs/excipients and packaging materials in CCPs & SNSFs.
• Provide responses to SFDA and other regulatory authorities.

Skills

Regulatory affairs

eCTD submissions

Cross-functional coordination

Education

Bachelor's degree in Science or Pharmacy

Job description

Pharmaceutical Solutions Industry Ltd "PSI" in Jeddah seeks an Asst. Manager – Registration to lead the timely registration of PSI products in local and export markets. You will handle eCTD submissions to SFDA and other authorities, review data, and manage lifecycle changes.

Requires a Bachelor’s degree in Science or Pharmacy and at least 5 years’ regulatory experience in the pharma industry. This role involves close collaboration with QA, Production, and R&D teams.