Regulatory Affairs Consultant

About the Role

Cipla is seeking a dedicated Regulatory Affairs Consultant to join its team in Riyadh, Saudi Arabia. This full-time position is critical for ensuring regulatory compliance and supporting the full product lifecycle within the Saudi market. The role requires a professional with extensive experience in pharmaceutical regulatory affairs, focusing on strategic engagement with the Saudi Food and Drug Authority (SFDA) and internal stakeholders.

Regulatory Submissions and Lifecycle Management

• Review and submit new/renewal dossiers and variations, identifying gaps and ensuring completeness of applications, pricing forms, and eCTD sequences.
• Coordinate with Cipla India RA on project planning, submission proofs, and approval notifications, including providing signed artworks and approved dossiers.
• Support product classification according to SFDA guidelines and coordinate pharmacological evaluations for new molecules.
• Manage SFDA deficiencies, ensuring timely and accurate responses for dossiers and Drug Master Files (DMFs).
• Maintain market authorizations, renewals, and annual reports, ensuring ongoing compliance throughout the product lifecycle.
• Assess proposed changes to dossiers, classify them per SFDA rules, and provide regulatory due diligence for in-licensing projects.
• Assist with brand name checks, verification, and approval, and provide inputs on patent and data exclusivity requirements.

Regulatory Strategy and Intelligence

• Provide regulatory insights on RLD availability, the generic landscape, and registration feasibility in Saudi Arabia.
• Support the development of regulatory strategies from early development through submission, ensuring alignment with SFDA expectations.
• Monitor and disseminate SFDA circulars, guidelines, notifications, and deficiency letters, updating internal teams on new resolutions.
• Support clinical/Bioequivalence-related queries, review biowaiver justifications, and engage SFDA for clarifications and meetings.
• Seek SFDA guidance for off-guidance or exceptional scenarios and provide regulatory support for business continuity.
• Share and interpret upcoming guidelines, supporting their implementation and providing technical and soft-skill training to the team.
• Contribute to market intelligence and competitive benchmarking for complex product regulatory strategies.

Stakeholder Engagement and Compliance

• Act as the primary liaison between Cipla India RA and the SFDA for all regulatory communications.
• Arrange and participate in SFDA pre-submission, exemption, and general regulatory meetings, especially for complex products.
• Handle official communications with SFDA, including English translations and meeting minutes.
• Lead dossier submissions, follow up with regulatory officials for timely processing, and coordinate SFDA inspections for manufacturing sites/BE centers.
• Forward SFDA queries to India RA and support the preparation of accurate responses.
• Build and maintain strong working relationships with consultants, Key Opinion Leaders (KOLs), Subject Matter Experts (SMEs), and MOH auditors.
• Support the preparation and submission of appeals against SFDA decisions and attend SFDA seminars on new regulations.
• Support payment of applicable SFDA fees for filings and inspections.

Qualifications and Experience

• Educational Qualifications: Bachelor's Degree in Pharmacy is required; a Master's Degree in Pharmacy is preferred.
• Relevant Experience: A minimum of 9-10 years of progressive experience in a regulatory affairs department within a reputable pharmaceutical company in Saudi Arabia.
• Experience should include man management responsibilities.

Additional Responsibilities

• Support regulatory aspects of business initiatives, including due diligence, tech transfer, and local manufacturing projects.
• Provide information on Marketing Authorization Holder (MAH) and Pharmacovigilance (PV) requirements, coordinating communication and meetings with SFDA.
• Support the identification and approval of SFDA-approved secondary packaging sites.
• Manage Arabic ↔ English translations for all regulatory documents, artworks, Patient Information Leaflets (PILs), and pack inserts.
• Prepare and submit Certificate of Pharmaceutical Product (COPP) applications to SFDA, including notarization and legalization steps.