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 PVrelated 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. InLicensing Due Diligence
- Provide regulatory due diligence inputs for inlicensing 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, fasttrack pathways, etc.
II. Query & BE Support
- Support clinical/Bioequivalencerelated queries and review biowaiver justifications.
- Engage SFDA for clarifications; arrange meetings when needed.
- Provide inputs on draft proposals, technical justifications, exemption requests, and presubmission meetings.
III. Handling Exceptions
- Seek SFDA guidance for offguidance 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 inhouse and inlicensing products.
VI. New Guidance Implementation
- Share and interpret upcoming guidelines and support their implementation for compliance.
VII. Training
- Provide technical and softskill 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 presubmission 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 endtoend 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. CrossFunctional 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 outofguidance 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 SFDAapproved 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.
