{
  "$schema": "https://cvjson.com/schema/v1.json",
  "basics": {
    "name": "Maria Othman (Khawaja)",
    "label": "Doctor of Pharmacy (PharmaD)",
    "summary": "Bringing strong interpersonal and communication skills, with a knack for problem-solving and adaptability. Proven ability to work collaboratively in team environments while maintaining a high level of organisation and attention to detail. Eager to contribute enthusiasm and commitment to achieving organisational goals.",
    "location": "Amman, Jordan"
  },
  "work": [
    {
      "company": "MS Pharma Jordan",
      "position": "In Licensing RA Compliance Senior Officer",
      "location": "Amman, Jordan",
      "startDate": "2026-05",
      "current": true,
      "highlights": [
        "Led over 3000 regulatory changes per year from more than 5 partners and over 10 regulatory authorities",
        "Specialized in licensing and regulatory compliance for pharmaceutical products",
        "Collaborated with cross-functional teams to ensure adherence to local and international regulations",
        "Conducted audits and assessments to maintain quality standards and compliance",
        "Developed and implemented training programs for staff on regulatory requirements",
        "Liaised with regulatory authorities to facilitate product approvals and registrations"
      ]
    },
    {
      "company": "MS Pharma",
      "position": "In Licensing RA Compliance Officer",
      "location": "Amman, Jordan",
      "startDate": "2023-05",
      "highlights": [
        "Preparing, auditing, organizing, and managing documents related to biosimilars new submissions, renewals, and variations, ensuring compliance with regulations by USFDA, EMA, and MENA regions with high-quality standards.",
        "Analyzing Health Authority deficiency letters, proposing and preparing responses adhering to strict timelines and guidelines.",
        "Representing the company in biotech-related external/internal meetings and communications with global agents, partners, suppliers, and health agencies.",
        "Proactively taking initiatives and demonstrating a dynamic approach to managing changing business needs and environment.",
        "Participating in audit preparations and inspections, addressing any findings promptly to maintain certifications.",
        "Implementing Quality Management Systems in line with regulatory requirements to improve operational efficiency and provide the required RA assessment/action for change control.",
        "Maintaining up-to-date knowledge of regulatory changes and communicating impacts to relevant departments.",
        "Preparing and reviewing SOPs related to the RA department."
      ]
    },
    {
      "company": "Chanelle Pharma Group",
      "position": "Regulatory Affairs Executive",
      "location": "Amman, Jordan",
      "startDate": "2021-07",
      "endDate": "2023-04",
      "highlights": [
        "Determined the regulatory submission procedure and documentation required in each situation, including updates to product designs or labels.",
        "Organized detailed responses to agency requests (EMA).",
        "Coordinated timely submission and documentation preparation to meet the requirements set forth by agencies (EU).",
        "Maintained the technical files required to obtain and sustain regulatory approvals.",
        "Assisted team members and managers with tasks to maintain productivity and meet project milestones.",
        "Coordinated with other departments in preparing PQR, PSUR, PSMF, CAPA, CCR, etc.",
        "Prepared and reviewed SOPs related to the RA department.",
        "Assisted governmental inspectors before, during, and after inspections."
      ]
    },
    {
      "company": "Azad Pharmacy",
      "position": "Community Pharmacist",
      "location": "Amman, Jordan",
      "startDate": "2019-09",
      "endDate": "2021-06",
      "highlights": [
        "Carefully reviewed new prescriptions against the patient's history.",
        "Advised patients on how to safely take and store drugs.",
        "Created a positive pharmacy image.",
        "Managed daily tasks and sought opportunities to go beyond requirements and support business targets.",
        "Monitored patient progress and assessment results with physicians."
      ]
    },
    {
      "company": "Hikma Pharmaceuticals",
      "position": "Intern Trainee",
      "location": "Amman, Jordan",
      "startDate": "2019-06",
      "endDate": "2019-08",
      "highlights": [
        "Performed trials on HPLC and dissolution tests on different batches.",
        "Modified the DMF profile and checked all the requirements needed to submit the file to the FDA.",
        "Checked the list of methods of analysis and NDC numbers.",
        "Performed validation (DQ, PQ, OQ, IQ) and reviewed their reports."
      ]
    }
  ],
  "education": [
    {
      "institution": "University of Jordan",
      "degree": "Bachelor of Pharmacy",
      "field": "Pharmacy",
      "endDate": "2018",
      "score": "3.7"
    }
  ],
  "skills": [
    "Biosimilar Products",
    "Regulatory Compliance",
    "Change Control Management",
    "Variation Management",
    "Team Leadership",
    "Training and Mentorship",
    "Regulatory Strategy Development",
    "Effective Communication",
    "Public Speaking",
    "Strategic Planning",
    "Excellent Written Skills",
    "Data Interpretation",
    "Problem Solving",
    "Teamwork and Motivation"
  ],
  "languages": [
    {
      "language": "Arabic",
      "fluency": "Native"
    },
    {
      "language": "English",
      "fluency": "Advanced"
    }
  ],
  "certificates": [
    {
      "name": "Regulatory Inspection Readiness Methodology",
      "issuer": "ZoneTehcs",
      "date": "2026-03"
    },
    {
      "name": "Biosimilars Regulations & File Assessment”",
      "issuer": "APEX Pharmaceutical Service",
      "date": "2025-09"
    },
    {
      "name": "Biosimilars guidelines, evolution and regulation updates”",
      "issuer": "APEX Pharmaceutical Services",
      "date": "2026-01"
    }
  ],
  "referencesMode": "on-request",
  "availability": {
    "status": "open",
    "sponsorship": false
  },
  "ats": {
    "keywords": [
      "In Licensing RA Compliance Senior Officer",
      "MS Pharma Jordan",
      "In Licensing RA Compliance Officer",
      "MS Pharma",
      "Regulatory Affairs Executive",
      "Chanelle Pharma Group",
      "Community Pharmacist",
      "Azad Pharmacy",
      "Intern Trainee",
      "Hikma Pharmaceuticals",
      "Pharmacy",
      "Biosimilar Products",
      "Regulatory Compliance",
      "Change Control Management",
      "Variation Management",
      "Team Leadership",
      "Training and Mentorship",
      "Regulatory Strategy Development",
      "Effective Communication",
      "Public Speaking",
      "Strategic Planning",
      "Excellent Written Skills",
      "Data Interpretation",
      "Problem Solving",
      "Teamwork and Motivation",
      "Arabic",
      "English",
      "Regulatory Inspection Readiness Methodology",
      "Biosimilars Regulations & File Assessment”",
      "Biosimilars guidelines, evolution and regulation updates”",
      "Doctor of Pharmacy (PharmaD)"
    ],
    "yearsOfExperience": 0,
    "seniority": "entry",
    "highestEducation": "Bachelor's"
  },
  "verification": {
    "email": true,
    "platform": "freecv.org"
  },
  "i18n": {
    "primary": "en"
  },
  "meta": {
    "version": "1.2.2",
    "canonical": "https://livelink.cv/maria-othmankhawaja/cv.json",
    "lastModified": "2026-08-26T14:05:45.317Z",
    "generator": "FreeCV.org"
  }
}