Regulatory Affairs Consultant

About the role

The Regulatory Affairs Consultant will support Cipla India and local teams in obtaining and maintaining product authorisations with the Saudi Food and Drug Authority (SFDA). The role involves end‑to‑end dossier management, submission monitoring, and post‑approval activities across the product lifecycle.

Key responsibilities

• Review and prepare new, renewal and variation dossiers, identify gaps and ensure completeness of eCTD sequences.
• Upload submissions to the SDR portal, monitor status changes, and manage deficiency responses and appeals.
• Coordinate project planning, attend teleconferences and provide actionable inputs for registration plans.
• Prepare and share submission proofs, approved artwork, and final eCTD packages with the India RA team.
• Classify products according to SFDA guidelines and liaise with the Authority for pharmacological evaluations.
• Notify the India RA of approvals, share certificates, and support corrective actions.
• Develop labeling (carton, foil, insert) and artwork in both English and Arabic, ensuring compliance with SFDA standards.
• Support preparation of Module 1 administrative documents and pricing forms.
• Conduct compliance reviews of dossiers and DMFs, manage deficiencies, and provide quality input for API DMF responses.
• Maintain market authorisations, renewals, annual reports and oversee lifecycle compliance.
• Assess change requests, classify them per SFDA rules and validate decisions with the Authority.
• Provide regulatory due‑diligence for in‑licensing projects and contribute to portfolio and regulatory strategy development.

Required profile

• Strong knowledge of SFDA regulations and submission requirements.
• Experience preparing and reviewing eCTD dossiers for pharmaceuticals.
• Ability to manage labeling, artwork and Arabic translation tasks.
• Proven track record in handling regulatory deficiencies and appeals.
• Excellent coordination skills with cross‑functional and international teams.

Required skills

• eCTD submission preparation
• SFDA regulatory processes
• SDR portal usage
• Arabic translation for labeling
• Labeling and artwork creation
• Regulatory dossier review and management