Regulatory Affairs - KSA

<div><h3>Regulatory Submission and Monitoring</h3><ul><li>Review new/renewal dossiers and variations, identify gaps, and share observations with Cipla India RA.</li><li>Ensure completeness of application, pricing forms, deficiency responses, and final eCTD sequences.</li><li>Upload sequences on SDR portal with India RA and share back the submitted package.</li><li>Continuously monitor SDR portal, update India RA on SFDA status changes, deficiencies, approvals/rejections, and support appeals where required.</li></ul><h3>II. Project Planning</h3><ul><li>Support execution of detailed registration/renewal/variation plans by coordinating with Cipla India RA.</li><li>Join scheduled telecons and provide inputs on next steps and outstanding action points.</li></ul><h3>III. Submission Proof&Approvals</h3><ul><li>Share complete eCTD sequences and submission proofs (with English translation) with India RA.</li><li>After approval, provide signed artwork, approved dossiers, and final eCTD sequences for renewals/variations.</li></ul><h3>IV. Product Classification</h3><ul><li>Provide input on product categorization as per SFDA guidelines and confirm classification with Authority.</li><li>Coordinate with SFDA for pharmacological evaluation for new molecules.</li></ul><h3>V. Approval Notification</h3><ul><li>Inform India RA immediately about any approvals.</li><li>Share certificates, approved dossiers/artworks, and translations.</li><li>Support Authority corrections/ amendments when required.</li></ul><h3>VI. Labelling&Artwork</h3><ul><li>Review SPC, PIL, and artworks; provide PV-related updates and Arabic translations.</li><li>Approve final bilingual artworks with signature and date.</li></ul><h3>VII. Module 1 Support</h3><ul><li>Support preparation of Module 1 administrative documents, pack artworks, application/pricing forms, etc.</li></ul><h3>VIII. Compliance Review</h3><ul><li>Review dossiers and DMFs to ensure accuracy, completeness, and compliance with SFDA expectations for faster approvals.</li><li>Track SFDA deficiencies and support timely, accurate responses for dossiers and DMFs.</li><li>Provide quality input for API DMF responses (in-house&outsourced).</li></ul><h3>X. Lifecycle Maintenance</h3><ul><li>Maintain market authorizations, renewals, annual reports, and ensure ongoing compliance throughout the product lifecycle.</li></ul><h3>XI. Change Evaluation</h3><ul><li>Assess proposed changes/amendments to dossiers, classify them as per SFDA rules, and validate decisions with SFDA when needed.</li><li>Provide regulatory due diligence inputs for in‑licensing projects to confirm dossier suitability/availability.</li></ul><h3>2. Support to Portfolio / Product Development&Regulatory Strategy Finalization</h3><ul><li>Provide regulatory insights on RLD availability, generic landscape, and registration feasibility in Saudi Arabia.</li><li>Arrange RLD documentation when required.</li></ul><h3>II. Regulatory Strategy</h3><ul><li>Support development of regulatory strategies (innovator vs. generic routes) from early development through submission.</li><li>Ensure correct documentation and data generation aligned with SFDA expectations.</li></ul><h3>III. Guideline Updates</h3><ul><li>Share new SFDA guidelines with teams and provide timely regulatory input during product development when needed.</li></ul><h3>3. Regulatory Intelligence Support</h3><h3>I. Monitoring&Updates</h3><ul><li>Share SFDA circulars, guidelines, notifications, and deficiency letters in English.</li><li>Regularly update India RA on new resolutions impacting registration, labeling, BE requirements, fast‑track pathways, etc.</li></ul><h3>II. Query&BE Support</h3><ul><li>Support clinical/Bioequivalence‑related queries and review biowaiver justifications.</li><li>Engage SFDA for clarifications; arrange meetings when needed.</li><li>Provide inputs on draft proposals, technical justifications, exemption requests, and pre‑submission meetings.</li></ul><h3>III. Handling Exceptions</h3><ul><li>Seek SFDA guidance for off‑guidance or exceptional scenarios and share updates with India RA.</li><li>Discuss key points in scheduled telecons and arrange further meetings if required.</li><li>Provide innovator pack details, inserts, and reference documents to enable alignment of Cipla pack inserts with SFDA expectations.</li></ul><h3>V. Business Support</h3><ul><li>Provide regulatory support to ensure uninterrupted supply and serviceability for in‑house and in‑licensing products.</li></ul><h3>VI. New Guidance Implementation</h3><ul><li>Share and interpret upcoming guidelines and support their implementation for compliance.</li></ul><h3>VII. Training</h3><ul><li>Provide technical and soft‑skill training to ensure team readiness per current regulatory expectations.</li><li>Share public consultations, amendments, and final SFDA guidance; provide strategic input for new development and registrations.</li><li>Benchmark Cipla’s regulatory strategies against other pharma companies f