As the Global Regulatory Affairs Manager at Dayonix, I develop and implement regulatory strategies to ensure our products meet compliance standards and are accessible across international markets, including the GCC, South Korea, the UK, Serbia, and Myanmar. My role bridges regulatory requirements with Dayonix’s market objectives, overseeing product registration, compliance, and cross-functional collaboration to support global growth.Key Responsibilities:• Product Registration: Manage the full registration process, from documentation to regulatory submissions, to secure timely product approvals.• Strategic Planning: Develop flexible regulatory strategies to support market entry, aligning with changing international standards.• Documentation Compliance: Maintain precise regulatory records to support compliance and regulatory reviews.• Cross-functional collaboration: Work closely with R&D, Quality Assurance, Marketing, and Sales teams to meet regulatory standards seamlessly.• Regulatory Intelligence: Monitor regulatory changes and guide teams to ensure ongoing compliance.• Regulatory Liaison: Serves as the primary contact with global regulatory authorities, managing communication and building strong relationships.• Team Training: Provide guidance and training to internal teams on international compliance standards.• Regional Compliance Oversight: Ensure adherence to regulatory requirements across various regions, from Europe to Asia.Key Achievements:• Successfully obtained product approvals across multiple markets, streamlining compliance and reducing time-to-market.• Drove Dayonix’s expansion into new global markets with strategic regulatory planning.• Registered over 75 products across 10 countries, underscoring a track record of regulatory success.With a focus on efficiency and regulatory excellence, I am dedicated to ensuring safe, compliant, and strategic market access for Dayonix’s innovative products worldwide.

As the Regulatory Affairs Manager in Iran, I ensure that all regulatory activities align with the Iranian FDA and international guidelines, supporting the registration and compliance of pharmaceutical, supplement, and herbal products. My role includes preparing and reviewing regulatory submissions, developing SOPs, and managing compliance processes to maintain quality and regulatory standards. Key Responsibilities:• eCTD Dossier Preparation: Support the preparation, review, and submission of eCTD dossiers for regulatory approvals, ensuring accuracy and completeness.• SOP Development: Develop and update Standard Operating Procedures (SOPs) for Chemistry, Manufacturing, and Controls (CMC) and the Quality Overall Summary (QOS) sections to enhance regulatory compliance.• Scientific Data Extraction: Extract and summarize critical scientific information from development reports to support regulatory submissions and ensure transparency.• Regulatory Collaboration: Collaborate closely with the Iranian FDA to address regulatory issues and respond effectively to information requests.• Compliance Assurance: Ensure all processes and submissions comply with Iranian FDA and International guidelines.• Procurement Oversight: Manage procurement processes for raw materials used in the manufacturing of medicinal products, ensuring adherence to regulatory standards.• Quality Management: Oversee the logging of deviations, Out-of-Specification (OOS) results, and complaints into the quality management system, facilitating root cause analysis and Corrective and Preventive Actions (CAPA).• Regulatory Assessment for Acquisitions: Work alongside the Business Development and Licensing team to assess regulatory aspects of potential acquisition projects. Key Achievements:• Successfully registered over 124 products in the supplements and herbal categories, demonstrating a strong track record in regulatory approvals

As the Qualified Person for Cosmetic and Food Products, I held responsibility for the safety, quality, and regulatory compliance of all products manufactured by the company. This involved overseeing quality assurance, ensuring product safety, and managing the entire product registration process with the Iranian Food and Drug Administration. My role required close collaboration with the regulatory department to meet legislative requirements and develop strong relationships with retailers and external manufacturers.Key Responsibilities:• Quality and Safety Oversight: Ensure all cosmetic and food products, including energy drinks, meet safety, quality, and legal standards.• Quality Assurance Management: Monitor and maintain the company's and customers' quality assurance systems, conducting food safety audits and implementing HACCP protocols.• Technical Documentation: Prepare and present technical documents required for product compliance and registration.• Regulatory Compliance and Registration: Lead the product registration process with the Iranian FDA, ensuring all requirements are met for successful market entry.• Collaboration with Retailers and Manufacturers: Build and maintain strong, supportive relationships with retailers and manage partnerships with external manufacturers.Key Achievements:• Successfully registered 12 cosmetic and skincare products under the Wellman and Perfectil brands.• Achieved registration of 2 energy drinks under the Wellman and Wellwoman brands.Skills and Strengths:• Expertise in quality assurance and product safety in the cosmetics and food sectors.• Strong understanding of regulatory compliance processes, particularly with the Iranian FDA.• Proven ability to manage product registration, ensuring adherence to all legal and quality standards.

As an R&D Specialist, I played a crucial role in advancing the company’s product portfolio by leading formulation improvements and troubleshooting production challenges. My responsibilities included researching, planning, and implementing new protocols and programs and overseeing the development and optimization of various products to ensure compliance with GMP standards.Key Responsibilities:• Product Formulation Improvement: Successfully revised the formulation over 20 supplement and herbal medicine products and six antibiotic and anti-diabetic drugs, enhancing their efficacy and compliance with regulatory standards.• Production Troubleshooting: Addressed and resolved production issues, ensuring smooth manufacturing processes and product consistency.• Protocol Development and Implementation: Conducted research and developed new programs and protocols to streamline product development and production workflows.• GMP Compliance Assurance: Ensured that all products were produced by Good Manufacturing Practice (GMP) standards.Skills and Strengths:• Expertise in product formulation, particularly supplements, herbal medicines, and antibiotics.• Proficient in troubleshooting and resolving production challenges to maintain product quality.• Strong understanding of GMP standards and their application in production environments.• Collaborative skills to work effectively with cross-functional teams in R&D and production

As a Quality Assurance Specialist, I am responsible for monitoring, inspecting, and recommending corrective actions to enhance the quality of the company’s final products and processes to meet established quality standards. My role focuses on quality compliance, process improvement, and ensuring all products meet regulatory requirements.Key Responsibilities:• Quality Monitoring and Inspection: Conduct regular inspections of products and processes to identify areas for quality improvement.• Corrective Action Proposals: Recommend and implement measures to correct any quality deviations and enhance product consistency.• Process Improvement: Work closely with cross-functional teams to refine production processes and ensure adherence to quality standards.Key Achievement:• Collaborated in obtaining ISO 9001 certification for the company in 2021, demonstrating a commitment to quality management and continuous improvement.Skills and Strengths:• Proficient in quality assurance practices, focusing on monitoring and improving product quality.• Skilled in identifying process improvements and implementing corrective actions.• Experience in supporting ISO certification processes and maintaining compliance with quality standards.

As the Head of the Blood Products Unit at the Zanjan Blood Transfusion Organization, I am responsible for receiving blood products sent from blood collection units, processing whole blood packs, and separating packed red cells, platelets, and plasma. My responsibilities include overseeing complex laboratory testing, ensuring accuracy and efficiency in production processes, and maintaining high-quality standards in the preparation and separation of blood products. Additionally, I am responsible for preparing weekly performance reports and submitting them to the unit manager.Key Responsibilities:• Blood Component Collection and Processing: Receive blood products from collection units, process whole blood packs, and separate packed red cells, platelets, and plasma.• Blood Typing and Screening: Perform blood typing and screening tests, cross-matching, DU testing, and fetal and cord blood screening to ensure compatibility and safety for transfusions.• Antibody Identification and Workup: Conduct comprehensive antibody workups, including identification, titer testing, and analysis of warm and cold agglutinins.• Weekly Reporting: Prepare weekly performance reports for the unit and submit them to the manager for evaluation and process improvement.Key Achievements:• Contributed to the preparation of 100,000 units of plasma for export to South Korea in 2016.Skills and Strengths:• Expertise in processing and preparation of blood components.• Proficient in advanced blood typing, antibody identification, and compatibility testing.• Strong attention to detail, ensuring high levels of accuracy and quality in production processes.• Effective leadership and organizational skills in managing production workflows and laboratory operations.