Zuleikha Fathima
Junior Regulatory Associate
Chennai
Summary
Proficient in current technology-backed global clinical research organization's regulations, standards and best practices. Analytical and detail-oriented professional focused on making sure products meet all relevant domestic and international regulatory requirements.
Overview
2
2
years of professional experience
6
6
years of post-secondary education
3
3
Languages
Work History
Junior Regulatory Associate
Navitas Life Sciences Pvt Ltd
Chennai
04.2022 - Current
- Serving as primary point of contact and publishing Subject Matter Expert (SME) on product Global Regulatory Team (GRT) meetings, Trail master file (TMF) and for APAC- malaysia country.
- Guiding the team on eCTD and regional submission requirements and compilation and publishing eCTD, NeeS, and other electronic regulatory submission types.
- Hands of experience in publishing tools (Liquent insight publisher), validation tools ( Lorenz eValidator), global document management system (GDMS) and Adobe Acrobat with ISI toolbox.
- Hands of experience in planning tools like iAssembly, COMPASS and etc.
- Extensively worked on eCTD, NeeS & Paper submissions. Publishing of promotional materials, labelling and clinical study reports.
- Acted as submission specialist, especially for EEU nationals - BAU portfolio which includes both submission and publishing of electronic dossier to point of contact within the set timeline.
- Performing quality control review of submission component documents to client and regulatory agency specifications.
- Proactively identifying and escalating submission issues as necessary.
- Actively participates in local and global publishing meetings to ensure publishing processes are consistent among regions.
Regulatory Associate - Trainee
Navitas Life Sciences Pvt Ltd
Chennai
07.2021 - 03.2022
- Understanding the requirements of various regulatory submissions including: IND, ANDA, NDA and DMF in CTD/ eCTD for various regulatory agencies including: US- FDA, EMA, Health Canada, Australia- TGA, etc.
- Assist regulatory associates/senior regulatory associates with document level publishing,including bookmarking,hypertext linking and preparing Table of contents as per the guidance.
- Provide submission publishing support, archiving and/or review of same day dispatch, major/complex submissions
- Skills: Archiving and publishing eCTD, Electronic, paper of various regulatory submissions, uploading documents in TMF, handling publishing tools and planning tools like PEARL and GDMS.
Education
HSC -
Vedanikethan Matriculation Higher Secondary School
Vellore 06.2014 - 03.2015
Bachelor Of Pharmacy -
SRM College of Pharmacy
Chengalpet 07.2015 - 05.2019
Master Of Pharmacy - Pharmaceutics
SRM College of Pharmacy
Chengalpet 07.2019 - 05.2021
Skills
Teamwork and Collaboration
Accomplishments
- Used Microsoft Excel to identify issues in the publishing build which helped my team to dispatch complex within same day.
- Received appreciation from client for archiving 100 % dispatches on time as planned for EEU national portfolio.
- Received appreciation from the clients for supporting team on successful dispatches of major/complex initial submissions on set timeline.
Timeline
Junior Regulatory Associate
Navitas Life Sciences Pvt Ltd
04.2022 - Current
Regulatory Associate - Trainee
Navitas Life Sciences Pvt Ltd
07.2021 - 03.2022
Master Of Pharmacy - Pharmaceutics
SRM College of Pharmacy
07.2019 - 05.2021
Bachelor Of Pharmacy -
SRM College of Pharmacy
07.2015 - 05.2019
HSC -
Vedanikethan Matriculation Higher Secondary School
06.2014 - 03.2015
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