Job Detail

Job Description

Key Duties & Responsibilities

• Manage electronic submission of registration dossiers in eCTD format to Saudi Food and Drug Authority (SFDA) and other regulatory authorities outside KSA.

• Review and verify registration files and supporting documentation prepared for regulatory submissions.

• Handle product lifecycle management, including registration, renewal, and variations, in compliance with SFDA and export country regulations.

• Maintain a complete and up-to-date registration archive, ensuring licenses, approvals, and product labeling remain valid.

• Check and manage applications submitted through the SFDA eSDR system.

• Coordinate with Quality Control (QC), Quality Assurance (QA), Production, and R&D departments to collect required regulatory data.

• Review and manage documents related to APIs, excipients, and packaging materials, including open parts of API CTD.

• Handle regulatory documentation associated with Change Control Proposals (CCPs) and Supplier Notification System Forms (SNSFs).

• Prepare and submit responses to queries, deficiencies, and comments raised by SFDA and other regulatory authorities.

• Stay updated on international regulatory legislation, guidelines, and practices in all export markets.

• Ensure Product Information (SPCs, PILs, and artworks) complies with relevant regulatory guidelines inside and outside KSA and update them as required.

Qualifications & Requirements

Education:

• Bachelor’s degree in Pharmacy, Science, or a related field

Experience:

• Minimum 5 years of experience in Regulatory Affairs within pharmaceutical companies

Job-Related Skills & Competencies

• Strong knowledge of regulatory guidelines for global markets

• Excellent planning and organizing skills

• Leadership and stakeholder coordination capabilities

• Strong critical thinking and problem-solving skills

• Effective communication skills in English and Arabic (verbal and written)

• Proficiency in MS Office and regulatory submission software

Skills Required

• Communication Skills