Regulatory Affairs Consultant

Position Overview

We are seeking a highly motivated and detail-oriented Regulatory Affairs Consultant to join our dynamic team. In this pivotal role, you will serve as the primary liaison between our organization and the Saudi Food & Drug Authority (SFDA), ensuring seamless compliance with regulatory requirements for product registration, lifecycle management, and strategic development. Your expertise will be instrumental in navigating the complexities of Saudi Arabian regulatory frameworks, driving successful dossier submissions, and maintaining market authorizations for our portfolio of pharmaceutical products.

Key Responsibilities

The Regulatory Affairs Consultant will be accountable for a broad spectrum of regulatory activities, including but not limited to:

• Registration Support:
  • Dossier Review & Submission: Conduct thorough reviews of new, renewal, and variation dossiers to identify gaps and ensure completeness. Collaborate with Cipla India RA to address deficiencies, prepare pricing forms, and finalize eCTD sequences. Upload sequences on the SDR portal and monitor SFDA status changes, including deficiencies, approvals, or rejections, while supporting appeals when necessary.
  • Project Planning: Assist in the execution of detailed registration, renewal, and variation plans by coordinating with Cipla India RA. Participate in scheduled teleconferences, providing strategic inputs on next steps and outstanding action items.
  • Submission Proof & Approvals: Share complete eCTD sequences and submission proofs, including English translations, with India RA. Upon approval, provide signed artwork, approved dossiers, and final eCTD sequences for renewals or variations.
  • Product Classification: Offer expert input on product categorization in alignment with SFDA guidelines. Confirm classifications with the Authority and coordinate pharmacological evaluations for new molecules.
  • Approval Notification: Immediately inform India RA of any approvals received. Share certificates, approved dossiers, artworks, and translations, and support Authority corrections or amendments as required.
  • Labelling & Artwork: Support the creation of labeling materials (carton, foil, insert) in compliance with SFDA guidelines. Review Summary of Product Characteristics (SPC), Patient Information Leaflets (PIL), and artworks, providing pharmacovigilance (PV)-related updates and Arabic translations. Approve final bilingual artworks with signature and date.
  • Module 1 Support: Assist in the preparation of Module 1 administrative documents, including pack artworks, application forms, and pricing forms.
  • Compliance Review: Conduct comprehensive reviews of dossiers and Drug Master Files (DMFs) to ensure accuracy, completeness, and compliance with SFDA expectations, thereby facilitating faster approvals.
  • Deficiency Management: Proactively track SFDA deficiencies and support the development of timely, accurate responses for dossiers and DMFs. Provide high-quality input for API DMF responses, whether handled in-house or outsourced.
  • Lifecycle Maintenance: Oversee market authorizations, renewals, annual reports, and ongoing compliance throughout the product lifecycle to ensure uninterrupted market access.
  • Change Evaluation: Assess proposed changes or amendments to dossiers, classify them according to SFDA rules, and validate decisions with the Authority when necessary.
  • In-Licensing Due Diligence: Provide regulatory due diligence inputs for in-licensing projects to confirm the suitability and availability of dossiers.
• Support to Portfolio / Product Development & Regulatory Strategy Finalization:
  • Portfolio Inputs: Deliver regulatory insights on Reference Listed Drug (RLD) availability, generic landscape, and registration feasibility in Saudi Arabia. Arrange for RLD documentation when required.
  • Regulatory Strategy: Collaborate on the development of regulatory strategies, whether pursuing innovator or generic routes, from early development through submission. Ensure alignment of documentation and data generation with SFDA expectations.
  • Guideline Updates: Disseminate new SFDA guidelines to relevant teams and provide timely regulatory input during product development as needed.
• Regulatory Intelligence Support:
  • Monitoring & Updates: Share SFDA circulars, guidelines, notifications, and deficiency letters in English. Regularly update India RA on new resolutions impacting registration, labeling, bioequivalence (BE) requirements, fast-track pathways, and other critical updates.
  • Query & BE Support: Address clinical and bioequivalence-related queries, review biowaiver justifications, and engage with the SFDA for clarifications. Arrange meetings when necessary and provide inputs on draft proposals, technical justifications, exemption requests, and pre-submission meetings.
  • Handling Exceptions: Seek SFDA guidance for off-guidance or exceptional scenarios, sharing updates with India RA. Discuss key points in scheduled teleconferences and arrange further meetings as required.
  • Innovator Information: Provide innovator pack details, inserts, and reference documents to align Cipla’s pack inserts with SFDA expectations.

Qualifications & Competencies

To excel in this role, candidates must possess a Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or a related field, along with a minimum of 5-7 years of experience in regulatory affairs, preferably within the pharmaceutical industry. Proficiency in SFDA regulations, eCTD submissions, and strong project management skills are essential. Fluency in English and Arabic is advantageous, as is prior experience in dossier preparation, labeling compliance, and regulatory strategy development. The ideal candidate will demonstrate exceptional attention to detail, strong communication skills, and the ability to collaborate effectively across global teams.