T: (905) 363-1182 x 241
F: (905) 542-7981
TF: 1 (877) 877-5152 x 000
2550 Argentia Rd., w Suite 119, w Mississauga ON w L5N 5R1
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Usha Goel is a Regulatory Affairs professional with 10 years plus experience in biologics, OTC consumer products, pharmaceuticals and medical devices. Experienced in regulatory filings for both Canadian marketed and development products. Experienced in many RA submissions for both Canada and US (eCTD, CTA, IND, DIN, NDS, sNDS, ANDS and NCs), RA labeling and product monograph revisions (including adverse events). Knowledgeable in CMC test method validation, ICH guidelines, Good Clinical Practice and clinical regulations (HIPAA, CFRs).
Skills & Highlights, Large project
- Prepared and submitted regulatory dossiers and files for CE Marking (European certification process for medical devices).
- Prepared and submitted to Health Canada Veterinary License application for generic injectable pharmaceutical product.
- Acted as key personnel responsible for label claims, language changes and finalization of package inserts and artwork for labels and cartons.
- Prepared and filed Canadian CTAs, CTSIs and NDS for pediatric vaccine products
- Prepared and filed US electronic BLA for pediatric vaccine products, maintenance of Canadian marketed product (notifiable changes, labeling updates). Direct communication with FDA.
- US IND and CTA filings: Involved in clinical development as RA member of US clinical team; review of clinical protocols, clinical final study reports, integrated summaries (ISS, ISI) investigator brochures, and clinical investigator documents such as 1572’s and IRB approvals. Review of eCRFs. Presented at Investigators meetings.
- Authored CMC drug product and substance sections for eCTDs for biological products (Modules 2 and 3) for US and EU markets, Notifable changes for Health Canada.
- Prepared STED class III Medical Device License Application
- Prepared S/NDS for OTC cough and cold product
- Maintainence of Establishment license for OTC and Site Licence for Natural Health Products, direct communication with Health Canada
- Assisted with dossier preparation for 510K for ELISA diagnostics products.
- Developed Enviromental Monitoring Program for aseptic processing pilot plant.
- Co-ordinated aseptic filling validation, sterilizer validation, gowning qualification, validation of sterility test operators and disinfectant qualification.
- Acted as key liaison during external audits by FDA, BARD Corporate, and Notified Body and lead Auditor for internal audits: Supervised team of 8 auditors.
- Performed cGMP compliance training, internal auditing, and clinical data audits.
- Master of Science in Microbiology, University of Toronto, Toronto, ON, Canada
- Bachelor of Science in Microbiology (Honours), University of Guelph, Guelph, ON, Canada.