Regulatory Affairs - KSA

Deputy Manager - HR Emerging Markets & Europe at Cipla Accountabilities
1. Registration Support

• 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…