Regulatory Affairs (reigstration) Section Head / specialist
Regulatory Affairs Section Head:
Strategic Regulatory Leadership: Lead and manage the Regulatory Affairs section, overseeing new registrations, renewals, re-registration, variations, and ongoing product maintenance in line with company priorities.
Regulatory Compliance: Maintain compliance with EDA requirements and applicable regulatory standards, assess regulatory risks, and coordinate the implementation of approved changes.
Dossier Review & Approval: Review, evaluate, and approve CTD/eCTD dossiers, registration files, and supporting technical documentation before submission, ensuring accuracy, completeness, and consistency.
Authority Representation & Follow-up: Represent the company before EDA, oversee submissions, follow up pending files and approvals, and coordinate timely responses to queries, deficiencies, and requests for additional information.
Registration Activities & Approvals: Monitor all stages of the registration process, including relevant stability, bioequivalence, analytical, pricing, labeling, packaging, and other approval requirements.
NFSA Activities: Oversee applicable food supplement registration, notification, renewal, and follow-up activities with NFSA, coordinating the required documentation and responses. Although the job is primarily EDA focused.
Team Supervision & Development: Guide and develop the Regulatory Affairs team, establish clear KPIs, assign responsibilities, prioritize workloads, and monitor submission timelines and outstanding commitments.
Regulatory Intelligence: Monitor regulatory updates, assess their impact on the portfolio, advise management, and adjust registration plans accordingly.
Cross-Functional Coordination & Reporting: Work closely with QA, QC, R&D, Production, and other relevant departments to obtain required data, resolve technical gaps, and maintain accurate regulatory trackers, records, and progress reports.
Regulatory Affairs Specialist:
Product Lifecycle Activities: Support new registrations, renewals, re-registration, variations, and other regulatory updates throughout the product lifecycle.
Authority Follow-up: Conduct routine follow-ups with EDA departments regarding submitted files, technical reviews, pending approvals, queries, and outstanding requirements, keeping the Section Head informed of progress and delays.
Registration Requirements & Approvals: Coordinate and follow up the applicable requirements for stability studies, bioequivalence studies, analytical testing, samples, pricing, labeling, artwork, packaging, and other registration-related approvals.
Technical Documentation & Data Collection: Collaborate with QA, QC, R&D, Production, and other departments to obtain technical dossiers, certificates of analysis, stability data, validation reports, manufacturing information, and other required documents.
Regulatory Responses & Changes: Prepare supporting documents and draft responses to authority queries, assist with regulatory assessments of product changes, and follow up the implementation of approved variations.
NFSA Support: Assist with applicable food supplement files, submissions, notifications, and follow-up activities under the Section Head’s guidance.
Tracking & Document Control: Maintain accurate registration databases, submission trackers, renewal schedules, licenses, correspondence, and document archives, ensuring records remain current and retrievable.
Section Support: Support submission schedules and team milestones, monitor outstanding requirements, and escalate issues that could affect compliance or delay approvals.
Additional Experience:
Previous experience with NFSA, herbal products, and/or veterinary products is an advantage. Previously working in CTD/eCTD files or overseeing any step in it's submission is also a plus.
Regulatory Affairs Section Head
Education: Bachelor’s degree in Pharmacy or a related scientific discipline; Pharmacy is preferred.
Experience: 7+ years of pharmaceutical Regulatory Affairs experience, including at least 2 years in a supervisory or Section Head role.
Technical Knowledge: Strong knowledge of EDA registration procedures, product lifecycle requirements, CTD/eCTD structure, and technical documentation.
Leadership: Proven team management, performance evaluation, workload prioritization, and cross-functional coordination skills.
Core Competencies: Strong communication, authority liaison, negotiation, and decision-making skills, with the ability to manage multiple submissions and regulatory risks.
Language & Systems: Professional proficiency in English and Microsoft Office, with experience using regulatory submission platforms and tracking systems.
Hands-on Approach — Section Head: This is primarily a hands-on role requiring direct involvement in dossier preparation and review, EDA submissions, authority follow-ups, and resolving outstanding requirements, alongside team supervision and coordination.
Regulatory Affairs Specialist
Education: Bachelor’s degree in Pharmacy or a related scientific discipline; Pharmacy is preferred.
Experience: 2–4 years of hands-on Regulatory Affairs experience within a pharmaceutical manufacturing company.
Technical Knowledge: Sound understanding of EDA registration procedures, renewals, variations, and supporting technical documentation.
Execution & Follow-up: Demonstrated ability to coordinate authority follow-ups, resolve outstanding requirements, and meet submission deadlines.
Core Competencies: Strong organizational skills, attention to detail, proactive communication, and effective coordination with technical departments.
Language & Systems: Professional proficiency in English and Microsoft Office, with good document control and regulatory tracking skills.
Additional details — Both Positions
Previous experience with NFSA, herbal products, and/or veterinary products is an advantage. Hands-on involvement in preparing, reviewing, or overseeing CTD/eCTD submissions is also valued.
Five-day working week, with one mandatory attendance day per week at the Badr factory, where the Registration Department is based. Factory attendance and external duties are coordinated according to the weekly schedule and workload.
The factory day is used to prepare required documents, reconcile payments and arrange cheques, review progress, conduct follow-ups and meetings, and plan the following week’s activities.