Regulatory Affairs Senior Manager, GRA, RPR MEA

Regulatory Affairs Senior Manager, GRA, RPR MEA

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• Strategic Focus
• Lead the development and execution of regulatory strategies for complex projects across KSA and MEA partner markets:
• Assess regulatory pathways and identify optimal submission strategies to accelerate approvals while ensuring compliance with local and global requirements.
• Anticipate regulatory challenges and proactively design mitigation plans to minimize risks and delays.
• Align regulatory strategies with business objectives, product lifecycle plans, and commercial priorities to support timely market access.
• Collaborate with cross‑functional teams (clinical, quality, manufacturing, commercial) to integrate regulatory considerations into project planning and decision‑making.
• Drive innovative approaches to meet evolving regulatory requirements and leverage regional insights to influence global strategy.
• Ensure oversight on key processes and frameworks to manage third‑party activities end‑to‑end, ensuring compliance with regulations and company standards; perform due diligence, monitor partner performance, and address deviations promptly.
• Technical Regulatory Responsibilities for KSA (in Coordination with Scientific Office Manager)
• Performing regulatory assessments for new products and variations.
• Preparing and compiling complete regulatory dossiers in alignment with SFDA requirements.
• Managing electronic submissions through the SDR portal via the Scientific Office in KSA.
• Responding to SFDA queries and deficiency letters promptly and effectively.
• Ensuring compliance with all local regulatory standards and timelines for approvals.
• Maintaining proactive communication with SFDA to facilitate smooth review processes.
• Also responsible for interaction with distributors and local partners for local manufacturing projects in KSA to ensure all regulatory activities are on track and aligned with compliance requirements.
• Regulatory Oversight for Partner Markets in MEA (Assigned Markets)
• Manage distributors and partners in assigned Partner Business markets.
• Prepare regulatory dossiers and provide regulatory assessments for these markets, ensuring compliance with local requirements and company standards.
• Ensure distributors submit dossiers to Health Authorities on time and in full compliance with regulatory requirements.
• Conduct audits and assessments to ensure compliance with local requirements and quality standards; implement corrective actions and risk mitigation strategies.
• Act as RA representative in audits/inspections and ensure readiness and timely CAPA closure.
• Serve as escalation point for partner‑related issues and align closely with GRA for contract management.
• Regulatory Intelligence & Authority Interaction
• Stay updated on regulatory requirements, guidelines, and industry trends; communicate changes to GRA and local teams.
• Communicate with Health Authorities, specifically SFDA, for all regulatory activities as needed, while ensuring coordination with the Scientific Office Manager.
• Submission Management
• Support regional regulatory teams in planning and submission preparation according to local requirements.
• Perform preparation and submission of regulatory dossiers, including variations, labeling, and NDAs, ensuring compliance with local regulations.
• Demonstrate strong knowledge of eCTD structure and requirements, including publishing tools (e.g., Docu Bridge), eCTD compilation, and technical validation.
• Ensure familiarity with electronic submission processes through SDR in Saudi Arabia; maintain awareness of all technical aspects related to electronic submissions.
• Systems & Data Integrity
• Maintain accurate and timely updates in regulatory systems and databases such as Veeva Vault RIM.
• Demonstrate advanced experience in Veeva, including:
• Managing end‑to‑end regulatory workflows within Veeva Vault RIM.
• Uploading, organizing, and maintaining submission documents in compliance with global and local standards.
• Ensuring data integrity and version control for all regulatory records.
• Generating reports and dashboards to track submission status and…