Experience

• 

  Julphar

  • United Arab Emirates

  • Regulatory Affairs Manager

    • Nov 2020 - Present
    • United Arab Emirates

    • Develop and implement regulatory strategies and plans to ensure approval of new product applications and to ensure compliance with global regulatory requirements. • Lead regulatory activities for product approval in Saudi FDA, UAE-MOHAPP, Other GCC Countries, North Africa, South Africa MCC, Turkey, CIS Countries, and other global markets. • Develop and maintain relationships with regulatory agencies. • Manage clinical trial applications, amendments, and renewals. • Prepare and review regulatory documents including protocols, study reports, and • NDA/BLA/IND submissions. • Negotiate and advocate with regulatory agencies on behalf of the company. • Monitor and analyse regulatory intelligence and provide updates to the executive team.

• 

  JAMJOOMPHARMA

  • Jeddah Governorate, Saudi Arabia

  • Assistant. Manager (R&D-Regulatory Affairs)

    • Jan 2011 - Oct 2020
    • Jeddah Governorate, Saudi Arabia

    • Manage the product registration process, including investigation, evaluation, and approval.• Conducted internal audits and compliance reviews.• Developed and maintained Standard Operating Procedures (SOPs) and Work Instructions.• Assisted in the development of training programs for employees.• Developed and implemented process improvement initiatives. • Responsible for the implementation of corrective and preventive actions (CAPA).• Developed regulatory strategies and plans to obtain approval for new product applications.• Prepared and reviewed regulatory documents for submission to regulatory agencies.• Managed clinical trial applications, amendments, and renewals. • Monitored and analyzed regulatory intelligence and provided updates to the executive team. • Negotiated and advocated with regulatory agencies on behalf of the company. • Developed and maintained relationships with regulatory agencies. • Developed regulatory strategies and plans to obtain approval for new product applications.• Prepared and reviewed regulatory documents for submission to regulatory agencies.• Maintain and update regulatory documents, such as product labeling, Technical Files and Design Dossiers.