Regulatory Affairs Intern (CAPSTONE PROJECT)

• Jan 2023 - Present

Quality Assurance Intern

• Jul 2022 - Dec 2022

~Experience with reviewing change controls for raw materials, manufacturing, analytical testing, and labeling. ~Coordinated the review of internal multi-product change controls, consolidating the evaluation of regulatory impact from each product. ~Managed timelines for the review of change controls in collaboration with Supply Chain colleagues. ~Experience with reviewing change controls for raw materials, manufacturing, analytical testing, and labeling. ~Coordinated the review of internal multi-product change controls, consolidating the evaluation of regulatory impact from each product. ~Managed timelines for the review of change controls in collaboration with Supply Chain colleagues.

Regulatory Affairs Intern

• Jul 2021 - Sep 2021

~Regulated on refining headwear device that will be launched as an FDA-regulated medical device accessory and critiqued the strategy for covering health insurance. ~Prepared various regulatory strategies for bringing the device to US market. ~Collaborated with sponsor to resolve issues regarding the coverage of insurance of the product ~Regulated on refining headwear device that will be launched as an FDA-regulated medical device accessory and critiqued the strategy for covering health insurance. ~Prepared various regulatory strategies for bringing the device to US market. ~Collaborated with sponsor to resolve issues regarding the coverage of insurance of the product

Regulatory Affairs Co-Op

• Jul 2020 - Dec 2020

~Conducted QC checks on regulatory documents to ensure Directive 2003/94/EC compliance with regulatory guidelines and requirements ~Managed regulatory document tracking and archiving using document management systems ~Assisted with the review and implementation of new regulatory publishing processes and tools ~Conducted QC checks on regulatory documents to ensure Directive 2003/94/EC compliance with regulatory guidelines and requirements ~Managed regulatory document tracking and archiving using document management systems ~Assisted with the review and implementation of new regulatory publishing processes and tools

Pharmaceutical trainee

• May 2019 - Jun 2019

A billion dollar pharmaceutical firm that specializes in treating diseases like HIV, ARV, and diabetes. Worked for the corporation's TRD division. Investigated manufacturing-line of pharmaceutical and medical device products while assisting the regulatory team with process validation. A billion dollar pharmaceutical firm that specializes in treating diseases like HIV, ARV, and diabetes. Worked for the corporation's TRD division. Investigated manufacturing-line of pharmaceutical and medical device products while assisting the regulatory team with process validation.

Pharmacy Intern

• Jun 2018 - Jul 2018

Worked in different Departments such as Inpatient Pharmacy, Outpatient Pharmacy, OT & ward. Dispensed prescriptions at the counter in outpatient Pharmacy department. Worked in different Departments such as Inpatient Pharmacy, Outpatient Pharmacy, OT & ward. Dispensed prescriptions at the counter in outpatient Pharmacy department.