Job Description
Main Purpose of Job Responsible for the preparation, publishing, submission, and lifecycle management of pharmaceutical registration dossiers in compliance with SFDA and applicable international regulatory requirements in ARAC . The role ensures timely product registrations, variations, renewals, and maintenance of marketing authorizations through effective dossier management and eCTD publishing. Functional Responsibilities - Prepare and submit pharmaceutical registration dossiers to SFDA and other regulatory authorities. - Manage registrations, variations, renewals, deficiency responses, and post-approval changes. - Ensure compliance with CTD/eCTD requirements, SFDA regulations, and ICH guidelines. - Monitor submission timelines and maintain regulatory trackers. - Compile, publish, validate, and maintain eCTD submissions and lifecycle sequences. - Ensure accurate document placement within Modules 1–5. - Perform technical validation and resolve publishing issues. - Maintain electronic regulatory archives and documentation. - Review and organize regulatory documents received from manufacturers and business partners. - Prepare application forms, labeling materials, product information, declarations, and other regulatory documents. - Monitor regulatory updates and assess their impact on registered products. - Support regulatory inspections, audits, and compliance activities. Job Requirements Qualifications - Bachelor’s degree in pharmacy. - Master’s degree in Regulatory Affairs or related discipline is an advantage. Experience - Minimum 6 years in related field. Language - Required English - proficient. - Preferred Arabic - proficient.
Similar jobs
- Regulatory Affairs Lead
AstraZeneca · Riyadh, Riyadh, Saudi Arabia
- Regulatory Affairs & Scientific Office Manager KSA
Riyadh, Saudi Arabia
- Regulatory, Legal & External Affairs Senior Expert
stc · Riyadh, Riyadh, Saudi Arabia
- Senior Regulatory Affairs Officer
Almarai - المراعي · Riyadh, Saudi Arabia