Regulatory Affairs - KSA

Regulatory Submission and Monitoring Review new/renewal dossiers and variations, identify gaps, and share observations with Cipla India RA. Ensure completeness of application, pricing forms, deficiency responses, and final eCTD sequences. Upload sequences on SDR portal with India RA and share back the submitted package. Continuously monitor SDR portal, update India RA on SFDA status changes, deficiencies, approvals/rejections, and support appeals where required. II. Project Planning Support execution of detailed registration/renewal/variation plans by coordinating with Cipla India RA. Join scheduled telecons and provide inputs on next steps and outstanding action points. III. Submission Proof & Approvals Share complete eCTD sequences and submission proofs (with English translation) with India RA. After approval, provide signed artwork, approved dossiers, and final eCTD sequences for renewals/variations. IV. Product Classification Provide input on product categorization as per SFDA guidelines and confirm classification with Authority. Coordinate with SFDA for pharmacological evaluation for new molecules. V. Approval Notification Inform India RA immediately about any approvals. Share certificates, approved dossiers/artworks, and translations. Support Authority corrections/ amendments when required. VI. Labelling & Artwork Review SPC, PIL, and artworks; provide PV-related updates and Arabic translations. Approve final bilingual artworks with signature and date. VII. Module 1 Support Support preparation of Module 1 administrative documents, pack artworks, application/pricing forms, etc. VIII. Compliance Review Review dossiers and DMFs to ensure accuracy, completeness, and compliance with SFDA expectations for faster approvals. Track SFDA deficiencies and support timely, accurate responses for dossiers and DMFs. Provide quality input for API DMF responses (in-house & outsourced). X. Lifecycle Maintenance Maintain market authorizations, renewals, annual reports, and ensure ongoing compliance throughout the product lifecycle. XI. Change Evaluation Assess proposed changes/amendments to dossiers, classify them as per SFDA rules, and validate decisions with SFDA when needed. Provide regulatory due diligence inputs for in licensing projects to confirm dossier suitability/availability. 2. Support to Portfolio / Product Development & Regulatory Strategy Finalization Provide regulatory insights on RLD availability, generic landscape, and registration feasibility in Saudi Arabia. Arrange RLD documentation when required. II. Regulatory Strategy Support development of regulatory strategies (innovator vs. generic routes) from early development through submission. Ensure correct documentation and data generation aligned with SFDA expectations. III. Guideline Updates Share new SFDA guidelines with teams and provide timely regulatory input during product development when needed. 3. Regulatory Intelligence Support I. Monitoring & Updates Share SFDA circulars, guidelines, notifications, and deficiency letters in English. Regularly update India RA on new resolutions impacting registration, labeling, BE requirements, fast track pathways, etc. II. Query & BE Support Support clinical/Bioequivalence related queries and review biowaiver justifications. Engage SFDA for clarifications; arrange meetings when needed. Provide inputs on draft proposals, technical justifications, exemption requests, and pre submission meetings. III. Handling Exceptions Seek SFDA guidance for off guidance or exceptional scenarios and share updates with India RA. Discuss key points in scheduled telecons and arrange further meetings if required. Provide innovator pack details, inserts, and reference documents to enable alignment of Cipla pack inserts with SFDA expectations. V. Business Support Provide regulatory support to ensure uninterrupted supply and serviceability for in house and in licensing products. VI. New Guidance Implementation Share and interpret upcoming guidelines and support their implementation for compliance. VII. Training Provide technical and soft skill training to ensure team readiness per current regulatory expectations. Share public consultations, amendments, and final SFDA guidance; provide strategic input for new development and registrations. Benchmark Cipla's regulatory strategies against other pharma companies for complex products. 4. Liaison with SFDA, KOLs, SMEs, Consultants I. Authority Interactions Arrange and participate in SFDA pre submission and exemption meetings, especially for complex products. II. Communication Management Handle official communications with SFDA, including English translations and meeting minutes. III. Site Inspections Coordinate SFDA inspections for manufacturing sites/BE centers, as needed. IV. Primary Contact Act as the main liaison between Cipla India RA and SFDA for all regulatory communication. Lead dossier submissions and follow up with regulatory official