Maria Othman (Khawaja)
Doctor of Pharmacy (PharmaD)
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.
Amman, Jordan
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Languages
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Skills
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Certifications
Work Experience
In Licensing RA Compliance Senior Officer
MS Pharma Jordan
May 2026 — PresentCurrentAmman, Jordan
- 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
In Licensing RA Compliance Officer
MS Pharma
May 2023 — Apr-2026Amman, Jordan
- 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.
Regulatory Affairs Executive
Chanelle Pharma Group
Jul 2021 — Apr 2023Amman, Jordan
- 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.
Community Pharmacist
Azad Pharmacy
Sep 2019 — Jun 2021Amman, Jordan
- 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.
Intern Trainee
Hikma Pharmaceuticals
Jun 2019 — Aug 2019Amman, Jordan
- 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.
Skills
Biosimilar ProductsRegulatory ComplianceChange Control ManagementVariation ManagementTeam LeadershipTraining and MentorshipRegulatory Strategy DevelopmentEffective CommunicationPublic SpeakingStrategic PlanningExcellent Written SkillsData InterpretationProblem SolvingTeamwork and Motivation
Education
Bachelor of Pharmacy, Pharmacy
University of Jordan
Certifications
Regulatory Inspection Readiness Methodology
ZoneTehcs
Biosimilars Regulations & File Assessment”
APEX Pharmaceutical Service
Biosimilars guidelines, evolution and regulation updates”
APEX Pharmaceutical Services
Languages
Arabic
Native
English
Advanced
References available upon request.