Senior Regulatory Affairs Specialist

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

Job Title:

Asst. Manager – Registration

Purpose of the Job:

Responsible for the timely registration of PSI products in local & export markets.

Registration actions/activities for the APIs (Active Pharmaceutical Ingredients), excipients, and packaging materials.

MAIN DUTIES AND RESPONSIBILITIES

• Manage electronic submission of Registration Files in eCTD format to SFDA and other regulatory authorities (outside KSA)
• Review the data in the registration files prepared for submission to the regulatory authorities.
• Life cycle management (registration, renewal, variation) of PSI products according to SFDA & Export countries’ regulations.
• Keep the registration archive complete (maintain and update the status of registration, renewal, and variation) and ensure that all licenses and labeling are up to date.
• Check the applications for the SFDA market on the eSDR site.
• Coordinate and follow up with the concerned departments like Q.C, Q.A., Production, and R&D for the collection of various data.
• Manage reviewing and responding to all documents relating to APIs/excipients and packaging materials (like the open part of API CTD) and related documents in both Change Control Proposals (CCPs) & Supplier Notification System Forms (SNSFs).
• Provide responses to queries and comments raised by SFDA & other regulatory authorities.
• Keep abreast of international legislation, guidelines, and customer practices in all countries that the company is exporting to.
• Represent regulatory affairs on the R&D product development project team to ensure that all regulatory requirements are met throughout the development process.

Education:

Bachelor’s degree in Science or Pharmacy

Experience:

5 years in Regulatory activities in pharma companies.