Regulatory Affairs Consultant

Cipla; Riyadh; On-site; SAR 300,000 - 550,000; Full time

Job summary

Cipla in Saudi Arabia is seeking an experienced Regulatory Affairs professional to review dossiers, coordinate with Cipla India RA, and manage submissions to the SFDA. The role involves ensuring complete applications, coordinating with authorities, and overseeing labeling, translations, and post-approval activities.

The ideal candidate will have 9–10 years in regulatory affairs in Saudi Arabia, strong English communication, and proven people management experience. A pharmacy degree is required.

Qualifications

• Bachelor or Master’s degree in Pharmacy.
• Good verbal and written English communications.
• 9–10 years of experience in regulatory affairs in a Saudi pharma company with people management experience.

Responsibilities

• Review dossiers and variations and coordinate with Cipla India RA.
• Ensure completeness of applications, pricing forms, and eCTD sequences, and monitor SFDA status.
• Lead regulatory submissions, labeling reviews, and artwork translations to meet SFDA requirements.
• Maintain liaison with SFDA/Authority, coordinate meetings, and support approvals and post-approval activities.
• Provide regulatory input for product development, lifecycle maintenance, and strategic regulatory planning.

Skills

English communication

People management

Education

Bachelor/Master in Pharmacy

Job description

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

Bachelor/ Master’s in pharmacy

Knowledge of local language

Good verbal and written English communication

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