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Dr. Anjali JamesRegulatory Affairs Officer
Location
Dubai, UAE
Email
[email protected]
Phone
+971508096489
Indian
Marital status
Spouse visa
23/09/1994
LinkedIn
https://www.linkedin.com/in/dr-anjali-james-400149170
Career Objective

Diligent, highly organized, and detail-oriented regulatory professional with 3 years of hands-on experience in EDE and Dubai Municipality regulatory processes. Seeking a challenging role in Regulatory Affairs, Pharmacovigilance, and Quality Assurance where I can contribute to regulatory compliance, product safety, and organizational growth while advancing my professional expertise.

Work Experience
Regulatory Affairs Officer & Pharmacist Incharge, Bridgeway Medical Systems
10/2023 – present | Dubai, UAE
  • •Executed end-to-end product registration processes with EDE/​MOHAP, including dossier compilation, submission, and follow-up through to final product approval.
  • •Managed medical device manufacturing site registrations and secured Marketing Authorization Holder (MAH) approvals with MOHAP.
  • •Conducted product classifications and efficiently managed both manufacturing site and product renewal submissions, ensuring full compliance with UAE regulatory frameworks and timelines
  • •Carried out Dubai municipality (DM) product registrations.
  • •Secured import permits through MOHAP and Dubai Municipality.
  • •Executed medical store endorsement procedures via the MOHAP portal.
  • •Obtained inquiry letters from the Ministry of Economy (MOE) for agency transfer.
  • •Applied medical waste disposal through MOHAP.
  • •Secured waste disposal permits from DM and coordinated with external waste management agencies to facilitate disposal.
  • •Handled product approvals and synchronized product information on the BrandSync portal, ensuring GS1 compliance for products distributed through DHA.
  • •Generated GS1 barcodes (GTINs) from the GS1 number bank.
  • •Monitored warehouse operations and conducted routine compliance audits to align with regulatory guidelines.
  • •Liaised and negotiated with regional regulatory authorities to ensure a smooth registration process.
  • •Possess knowledge of conventional product registration, including understanding of eCTD requirements and dossier preparation in alignment with regulatory standards.
  • •Acquired knowledge in the registration of GSL and herbal products with the MOHAP, ensuring adherence to national regulatory frameworks.
  • •Implemented automation for warehouse product entry and exit by enabling accurate barcode-based tracking, improving inventory control and operational efficiency.
  • •Prepared, reviewed, and validated comprehensive regulatory dossiers, ensuring all documentation met local specifications.
  • •Tracked regulatory document expiration dates and coordinated timely renewals with suppliers to maintain uninterrupted market access.
    • Junior Regulatory Affairs Executive, Nutripharm - Life Group
    04/2023 – 10/2023 | Dubai, UAE
  • •Managed registration processes for health supplements, cosmetics, biocides, personal care products, fragrances, and food products.
  • •Executed regulatory submissions to Dubai Municipality in compliance with local requirements.
  • •Proactively conducted detailed label reviews before product submission, identifying compliance gaps early and facilitating timely approvals from regulatory authorities.
  • •Prepared comprehensive dossiers for submission, ensuring alignment with regulatory specifications.
  • •Liaised with suppliers to secure documentation and meet regional regulatory body requirements.
  • •Maintained up-to-date regulatory documentation to support ongoing compliance.
    • Regulatory Affairs Intern, Bridgeway Medical Systems
    11/2022 – 04/2023 | Dubai
  • •Assisted with MOHAP classification and site registration activities.
  • •Prepared and submitted medical device import permit applications via MOHAP.
  • •Acquired working knowledge of Dubai Municipality registration and import procedures.
  • •Maintained and regularly updated regulatory documentation in line with current requirements.
  • •Coordinated the collection and organization of client documents for regulatory submissions.
  • •Maintained familiarity with the company’s product range.
  • •Supported warehouse compliance through routine maintenance and documentation checks.
    • Clinical Pharmacist Trainee, Dr. Shenoy’s CARE Hospital
    12/2020 – 11/2021 | Kerala, India
  • •Conducted routine follow-up with patients to monitor disease progression and assess quality of life.
  • •Provided individualized medication counseling to enhance therapy adherence, identify drug-related problems, and recommend management strategies based on disease activity.
  • •Accurately entered patient demographics, medication regimens, and disease histories into the Electronic Medical Record (EMR) system.
  • •Collected and managed clinical study data, ensuring accuracy and compliance with study protocols.
  • •Collaborated with multidisciplinary healthcare teams to support optimal patient care and clinical research objectives.
    • Clinical Pharmacist Intern, JSS Hospital, Mysore
    06/2018 – 05/2019 | Karnataka, India
  • •Provided pharmaceutical care services such as identifying, analyzing, and managing Drug-related problems.
  • •Documentation of all the clinical pharmacy activities and ensuring compliance with the NABH regulations.
  • •Reported Adverse Drug Reactions in consultation with the Physicians and supporting literature, and provided Drug Alert Cards to the patients presenting with the symptoms as a part of the National Pharmacovigilance Program of India (PvPI).
  • •Provided patient counseling on drug-drug interaction, drug-food interaction, Insulin therapy, use of various respiratory devices, correct use of prescription and OTC medications, and lifestyle modification.
  • •Recommended appropriate drug therapy to physicians, monitored therapy as per protocol, and initiated appropriate formulary procedures.
  • •Determined poison and prepared treatment protocol for each poison case to initiate and continue therapy.
  • •Exact Dose division for the pediatric and neonate population with proven scientific calculations.
    • Education
    Doctor of Pharmacy (Pharm D), JSS College of Pharmacy, Mysuru (Accredited by Accreditation Council for Pharmacy Education, USA).
    2013 – 2019 | Mysore, India
    Certificates
    Advanced Pharmacovigilance and Regulatory Affairs Certification

    From CCRPS Utah, USA (accredited by ACCRE, CPD & CME) (In Progress)

    Registered Pharmacist in Kerala State Pharmacy Council (KSPC)

    Registration no: 68450; Issued on 05-08-2019

    Dubai Health Authority Eligibility Letter for Registered Pharmacist

    DHA Unique ID: 47345156; Issued on 07-08-2023

    Introduction to Pharmacovigilance

    from Uppsala Monitoring Centre, Issued on November 2023

    Ministry of Health and Prevention Professional License for Phamacist

    Reference no:290728 ; Issued on 12-08-2023

    Professional Regulatory Affairs GCC certification from Dubai College of Pharmacy

    (eCTD, GMP, Pharmacoeconomics, Stability Studies, Labeling Guidelines, Pharmacovigilance, Pricing, Pharma & Cosmetic Registration, GSL, Gulf Health Council Registration, Food Beverages Regulatory)

    Licensed basic life support provider under American Heart Association -reference number: df6999d1b1b7.
    Skills
    Worked with MOHAP portal, DHA Montaji portal, GS1 UAE, Brandsync (Tarmeez) & Zoho application
    Efficient computer skills in MS Office
    Ability to maintain high level of confidentiality and professional discretion
    Knowledge in using Vigi Flow Database, the Iowa Drug Information Services (IDIS), PubMed, IBM Micromedex Drug reference, UpToDate, Medscape, Epocrates and Science Direct
    Ability to manage multiple responsibilities with detail orientation, set priorities and meet deadlines
    Projects
    MEDICATION -RELATED ADMISSIONS TO TERTIARY CARE HOSPITAL
    09/2017 – 02/2018
  • •Dissertation: “Medication-related admissions to tertiary care hospital” under the guidance of Dr. M Ramesh (Head of department of pharmacy practice).
  • •Madhan Ramesh, Aishwarya Patil, Anjali James, Grishma Grace John, Melwala Mihir, Sri Harsha Chalasani . Medication related hospital admissions to a tertiary care teaching hospital: A prospective cross sectional study. Pharmacoepidemiology and Drug Safety, Wiley. 2019; 28( SI): 355-356
    • Declaration
    I do hereby declare that the particulars of information and facts stated herein above are true, correct and complete to the best of my knowledge and belief.

    Dr. Anjali James

    Dubai