Regulatory Affairs Specialist

• Sep 2021 - Present

Prepare and / or review submissions to Health Canada and US FDA – NHPs, Medical Devices, Drugs etc. Conduct regulatory assessment of new products and prepare reports. Review and approve various product labeling components and marketing materials. Review internal documentation (master batch records, specifications, labeling, product monographs) for adherence to regulatory guidelines. Prepare written responses to correspondences from regulatory agencies and timely submissions. Prepare and / or review submissions to Health Canada and US FDA – NHPs, Medical Devices, Drugs etc. Conduct regulatory assessment of new products and prepare reports. Review and approve various product labeling components and marketing materials. Review internal documentation (master batch records, specifications, labeling, product monographs) for adherence to regulatory guidelines. Prepare written responses to correspondences from regulatory agencies and timely submissions.

Regulatory Affairs Associate

• Mar 2021 - Sep 2021

Manage regulatory submissions, life cycle management of NHP, drugs, cosmetics and medical devices. Provide regulatory advice related to strategic product development, formulation support, gap analysis, market research report, and data analysis. Execute post-marketing surveillance programs, Risk Management Plan, Pharmacovigilance reporting and support. Manage regulatory submissions, life cycle management of NHP, drugs, cosmetics and medical devices. Provide regulatory advice related to strategic product development, formulation support, gap analysis, market research report, and data analysis. Execute post-marketing surveillance programs, Risk Management Plan, Pharmacovigilance reporting and support.

Senior Research Scientist

• Oct 2015 - May 2020

Work as part of a highly collaborative interdisciplinary team in a clinical research environment and provide regulatory leadership to studies. Work closely with principal investigators and study team to ensure that all regulatory aspects of the studies are compliant. Prepare REB submissions; executed nonclinical study plans (efficacy, pharmacokinetic (PK) assessments and toxicology/safety studies); develop reports, reviews and summaries; and kept up to date with relevant scientific developments. Author and publish peer-reviewed scientific articles (10+ as first author).

Research Scientist

• Oct 2012 - Sep 2015

Design nonclinical experiments, conduct, document, and present research findings independently. Execute in vivo and in vitro experiments towards building models for metabolic disorders such as glucose intolerance, diabetes, and obesity. Conduct literature review, writing, and review of protocols, study manuals, and other study documents. Prepare research grants and funding applications/bids, supervised junior staff including technicians, ensure that quality standards are met. Distill complex information into accessible reports in visual, written, and oral formats.

Research Scientist II

• Apr 2009 - Sep 2012

I designed experiments and performed various cell and molecular biology techniques. Participated in protocol, consent, and investigator brochure review. Analyzed research data, managed the daily operations of the lab, participated significantly in abstract, poster, paper, and grant preparation. Reported research results and developments at meetings, scientific conferences, and in peer-reviewed journals.

ASLP Fellow

• Mar 2017 - Mar 2018

NYA Fellow

• May 2011 - Sep 2016

Visiting Researcher

• Apr 2013 - Jul 2013

Experiential scholarship in molecular biology including working with RNA and DNA, cloning, qPCR, Western blotting, immunohistochemistry, siRNA, mammalian cell transfection, and cell culture. Experiential scholarship in molecular biology including working with RNA and DNA, cloning, qPCR, Western blotting, immunohistochemistry, siRNA, mammalian cell transfection, and cell culture.

Postdoctoral Researcher

• Sep 2010 - Dec 2010