OVERVIEW
FOCUS AREAS
Regulatory Affairs Officer since February 2024, previously Senior Diagnostic Radiographer since 2019.
Medical Devices & Combination Projects
Drugs & Biologics
Regulatory Intelligence Projects
Ayesha Sultana studied Diagnostic Radiography BSc (Hons) at City University of London. She is an experienced MRI radiographer with a strong background in MRI, CT, and X-ray imaging, both at Bristol Royal Infirmary (BRI) and St. Mary’s Hospital. She is proficient in various medical device operation and contrast media usage. Ayesha has joined Eliquent as a Regulatory Affairs Officer and is continually developing her knowledge on Medical Devices & Combination Products, Drugs & Biologics and general Regulatory Intelligence projects.
Ayesha proficiently reviews a wide range of regulatory variations and conducts gap analysis reports for CMC dossiers. She aids in co-ordinating licensing and post-licensing procedures, including National, Mutual Recognition, and Centralized Applications, under the guidance of senior staff. In accordance with relevant regulatory guidance, Ayesha ensures the accuracy of updates to the Summary of Product Characteristics and Patient Information Leaflets, as well as checks labelling texts and mock-ups for clients. She conducts research to support regulatory strategy documents, maintains effective client communication, prepares medical device documentation, and provides monthly regulatory intelligence updates via emails. Additionally, Ayesha handles supportive technical and administrative tasks, such as quality control checks and filing, with precision.
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EDUCATION:
Bachelor of Science with Honours in Radiography (Diagnostic Imaging), City University of LondonCERTIFICATIONS:
Green Belt Certification on EU MDR 2017/745 in April 2024 -
PROFESSIONAL EXPERIENCE:
Regulatory Affairs Officer (RAO) since February 2024
Writing and review all types of variations, simple and complex
Gap analysis reports for CMC dossiers
Co-ordinate licensing and post licensing procedures on behalf of clients under senior staff guidance
Review updates to Summary of Product Characteristics and Patient Information Leaflets
Write or review labelling texts for clients, including checking of mock-ups
Writes sections of dossiers for Mutual Recognition/Decentralised procedures and Centralised procedures and co-coordinating those procedures through to approvals through EU
Participating in the writing of Module 2 and Module 3 documents
Research activities to support regulatory strategy documents
Communicating effectively with clients
Preparing Medical Device documentation
Monthly Regulatory Intelligence updates through emails
Supportive technical/administrative activities: QC check documents, filing etc.
Independent Research to support publication development.
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