Regulatory Affairs (reigstration) Section Head / specialist

• 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.
• 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.