Regulatory Affairs - KSA

Accountabilities:

1. Registration Support

I. Dossier Review & Submission

• 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

• Support 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 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.

IX. Deficiency Management

• 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.

XII. In‑Licensing Due Diligence

• Provide regulatory due diligence inputs for in‑licensing projects to confirm dossier suitability/availability.

2. Support to Portfolio / Product Development & Regulatory Strategy Finalization

I. Portfolio Inputs

• 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.

IV. Innovator Information

• 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.

VIII. Market Intelligence

• Share public consultations, amendments, and final SFDA guidance; provide strategic input for new development and registrations.

IX. Competitive Benchmarking

• 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.

V. Dossier Submission

• Lead dossier submissions and follow up with regulatory officials for timely processing.

VI. Meetings & Discussions

• Join regulatory meetings and arrange physical/virtual interactions with SFDA.

VII. Query Resolution

• Forward SFDA queries to India RA and support preparation of accurate responses.

VIII. Status Updates

• Provide periodic product registration updates and participate in scheduled telecons.

IX. Approval Coordination

• Manage end‑to‑end submission for new registrations, renewals, variations, and support resolution of queries to enable commercial orders.

X. Appeal Support

• Support preparation and submission of appeals against SFDA decisions.

XI. Representation

• Attend SFDA seminars and discussions on new regulations.

XII. Cross‑Functional Support

• Provide regulatory input to quality and other teams for deficiency resolutions.

XIII. Due Diligence

• Evaluate dossier availability and suitability for projects.

XIV. Relationship Building

• Build strong working relationships with consultants, KOLs, SMEs, and MOH auditors.

XV. Expert Consultation

• Seek expert opinions for complex product registrations.

XVI. Ministry Guidance

• Obtain MOH guidance on exceptional or out‑of‑guidance cases.

XVII. Reviewer Engagement

• Visit SFDA reviewers frequently to clarify guidance, queries, and development strategies.

XVIII. Fee Support

• Support payment of applicable SFDA fees for filings and inspections.

5. Support in MAH Responsibilities & Localization Projects

I. Brand Name Support

• Assist with brand name checks, verification, and approval as per SFDA rules.

II. Patent/Data Exclusivity

• Provide inputs on patent and data exclusivity requirements when needed.

III. Business Expansion

• Support regulatory aspects of business initiatives, including due diligence, tech transfer, and local manufacturing projects.

IV. MAH Compliance

• Provide information on MAH and PV requirements; coordinate communication and meetings with SFDA alongside RA/PV teams.

V. Packaging Sites

• Support identification and approval of SFDA‑approved secondary packaging sites.

6. Support with Respect to Translation

I. Document Translation

• Arrange Arabic ↔ English translations for all regulatory documents as needed.

II. Artwork Translation

• Support 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 Countries

• Prepare and submit COPP applications to SFDA and manage notarization/legalization steps upon request from Cipla India RA.

Educational qualifications:

Bachelor/ Master’s in pharmacy

Knowledge of local language

Good verbal and written English communication

Relevant experience:

9-10 years of experience in the regulatory affairs department in a reputed pharmaceutical company in a Saudi Arabia with man management experience.