Regulatory Affairs Consultant

Accountabilities:1. Registration SupportI. Dossier Review & SubmissionReview 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 PlanningSupport 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 & ApprovalsShare 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 ClassificationProvide input on product categorization as per SFDA guidelines and confirm classification with Authority.Coordinate with SFDA for pharmacological evaluation for new molecules.V. Approval NotificationInform India RA immediately about any approvals.Share certificates, approved dossiers/artworks, and translations.Support Authority corrections/ amendments when required.VI. Labelling & ArtworkSupport labeling (carton, foil, insert) creation as per SFDA guidelines.Review SPC, PIL, and artworks; provide PV‑related updates and Arabic translations.Approve final bilingual artworks with signature and date.VII. Module 1 SupportSupport preparation of Module 1 administrative documents, pack artworks, application/pricing forms, etc.VIII. Compliance ReviewReview dossiers and DMFs to ensure accuracy, completeness, and compliance with SFDA expectations for faster approvals.IX. Deficiency ManagementTrack SFDA deficiencies and support timely, accurate responses for dossiers and DMFs.Provide quality input for API DMF responses (in-house & outsourced).X. Lifecycle MaintenanceMaintain market authorizations, renewals, annual reports, and ensure ongoing compliance throughout the product lifecycle.XI. Change EvaluationAssess proposed changes/amendments to dossiers, classify them as per SFDA rules, and validate decisions with SFDA when needed.XII. In‑Licensing Due DiligenceProvide regulatory due diligence inputs for in‑licensing projects to confirm dossier suitability/availability.2. Support to Portfolio / Product Development & Regulatory Strategy FinalizationI. Portfolio InputsProvide regulatory insights on RLD availability, generic landscape, and registration feasibility in Saudi Arabia.Arrange RLD documentation when required.II. Regulatory StrategySupport 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 UpdatesShare new SFDA guidelines with teams and provide timely regulatory input during product development when needed.3. Regulatory Intelligence SupportI. Monitoring & UpdatesShare 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 SupportSupport 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 ExceptionsSeek 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.IV. Innovator InformationProvide innovator pack details, inserts, and reference documents to enable alignment of Cipla pack inserts with SFDA expectations.V. Business SupportProvide regulatory support to ensure uninterrupted supply and serviceability for in‑house and in‑licensing products.VI. New Guidance ImplementationShare and interpret upcoming guidelines and support their implementation for compliance.VII. TrainingProvide technical and soft‑skill training to ensure team readiness per current regulatory expectations.VIII. Market IntelligenceShare public consultations, amendments, and final SFDA guidance; provide strategic input for new development and registrations.IX. Competitive BenchmarkingBenchmark Cipla’s regulatory strategies against other pharma companies for complex products.4. Liaison with SFDA, KOLs, SMEs, ConsultantsI. Authority InteractionsArrange and participate in SFDA pre‑submission and exemption meetings, especially for complex products.II. Communication ManagementHandle official communications with SFDA, including English translations and meeting minutes.III. Site InspectionsCoordinate SFDA inspections for manufacturing sites/BE centers, as needed.IV. Primary ContactAct as the main liaison between Cipla India RA and SFDA for all regulatory communication.V. Dossier SubmissionLead dossier submissions and follow up with regulatory officials for timely processing.VI. Meetings & DiscussionsJoin regulatory meetings and arrange physical/virtual interactions with SFDA.VII. Query ResolutionForward SFDA queries to India RA and support preparation of accurate responses.VIII. Status UpdatesProvide periodic product registration updates and participate in scheduled telecons.IX. Approval CoordinationManage end‑to‑end submission for new registrations, renewals, variations, and support resolution of queries to enable commercial orders.X. Appeal SupportSupport preparation and submission of appeals against SFDA decisions.XI. RepresentationAttend SFDA seminars and discussions on new regulations.XII. Cross‑Functional SupportProvide regulatory input to quality and other teams for deficiency resolutions.XIII. Due DiligenceEvaluate dossier availability and suitability for projects.XIV. Relationship BuildingBuild strong working relationships with consultants, KOLs, SMEs, and MOH auditors.XV. Expert ConsultationSeek expert opinions for complex product registrations.XVI. Ministry GuidanceObtain MOH guidance on exceptional or out‑of‑guidance cases.XVII. Reviewer EngagementVisit SFDA reviewers frequently to clarify guidance, queries, and development strategies.XVIII. Fee SupportSupport payment of applicable SFDA fees for filings and inspections.5. Support in MAH Responsibilities & Localization ProjectsI. Brand Name SupportAssist with brand name checks, verification, and approval as per SFDA rules.II. Patent/Data ExclusivityProvide inputs on patent and data exclusivity requirements when needed.III. Business ExpansionSupport regulatory aspects of business initiatives, including due diligence, tech transfer, and local manufacturing projects.IV. MAH ComplianceProvide information on MAH and PV requirements; coordinate communication and meetings with SFDA alongside RA/PV teams.V. Packaging SitesSupport identification and approval of SFDA‑approved secondary packaging sites.6. Support with Respect to TranslationI. Document TranslationArrange Arabic ↔ English translations for all regulatory documents as needed.II. Artwork TranslationSupport translation of artworks, PILs, and pack inserts into Arabic and review bilingual versions for filing and commercial use.7. COPP Application to SFDA for Other CountriesPrepare and submit COPP applications to SFDA and manage notarization/legalization steps upon request from Cipla India RA.Educational qualifications: Bachelor/ Master’s in pharmacyKnowledge of local languageGood verbal and written English communicationRelevant experience: 9-10 years of experience in the regulatory affairs department in a reputed pharmaceutical company in a Saudi Arabia with man management experience.