International Regulatory Affairs

• Feb 2023 - Present

Regulatory Affairs Specialist

• Aug 2022 - Jan 2023

•Managed submission activities for regulatory approvals including the US premarket approvals (PMAs), US premarket notifications (510(k)s), post-approval reports, annual reports, Q-subs, IDEs, export certificates, and establishment registrations and device listings. •Developed, prepared, and submitted high-quality technical information for submission in geographies (US FDA, EU, and Health Canada). Established timelines, managed sub-team meetings relevant to the regulatory processes, and ensured timely execution. •Organized and maintained submission components associated with a regulatory submission electronically. This may include scanning, converting to pdf, bookmarking, hyper linking, electronic processing and publishing the submission to FDA etc. independently. •Reviewed and approved document change orders (DCOs), CAPA plans and reports, technical documents, test protocols and reports, risk management documents, labeling documents, and other documents as a key member of assigned project teams. Assessed product and manufacturing changes and developed regulatory assessments for each global market to impact current approvals. •In collaboration with Regulatory Management, project teams, and/or international partners, evaluated possible pathways to marketing authorization and recommended strategies and pathways that appropriately weigh the probability of success with potential risks to the business. •Updated departmental procedures as required and maintained up-to-date knowledge of domestic and international regulatory requirements and communicated requirements to project teams and management. Show less

Regulatory Affairs Specialist II

• Jan 2022 - Jul 2022

•Compiling and maintaining CMC documentation used to support international and domestic regulatory submissions (US FDA, EU and Health Canada). •Performing and communicating risk-based assessment of proposed CMC changes, product associated problems, submission requirements, regulatory compliance, and quality documentation requirements. •Drafting CMC-related deficiency responses to regulatory authorities with assessment of CMC-related product safety issues and providing input on consequent market actions. •Leading general Regulatory Affairs requests from foreign countries and within the group. •Assisting in compilation and preparation of submission packages including drafting of regulatory communications, routine regulatory reports, post-market reports. •Managing proposed regulatory changes to branded and private label products; including tracking and maintenance of all documentation. •Assisting in the development of regulatory strategy and update strategy based on internal review and market changes. •Maintaining tracking and control systems for stability data and other test data, and document archives •Providing regulatory input on product lifecycle planning and impact on drug products and an appropriate follow-up to inspections and audits. •Assisting in developing procedures and work instructions to ensure regulatory and quality compliance. •Participating in regulatory intelligence activities to monitor the impact of changing regulation on submission strategies and product requirements. •Assisting in preparing for technical meetings with regulatory agencies. •Assisting with management and maintaining the quality change control documentation system including initiation, review, and approval of CAPAs, deviations, and SCARs Show less

RSO Supervisor

• Sep 2021 - Dec 2021

Residential Safety Office Proctor

• Aug 2020 - Dec 2021

Student Success Guide

• Sep 2021 - Dec 2021

Regulatory Intern (Capstone Project)

• Sep 2021 - Dec 2021

-This project involves the creation of the first Instructions for Use (IFU) document for a novel, not-yet-FDA-approved, class II medical device (predicate already determined) that is being developed. -This project involves the creation of the first Instructions for Use (IFU) document for a novel, not-yet-FDA-approved, class II medical device (predicate already determined) that is being developed.

Facility Assistant-Cabot Athletics

• Jul 2021 - Dec 2021

Student Mentor

• Aug 2020 - Dec 2021

Student Proctor

• Sep 2020 - May 2021

Regulatory and Analytical Chemistry Co-op

• Sep 2020 - Apr 2021

•Worked on building, publishing, compiling, and reviewing IND submission including Annual Report, DSUR, New Protocols and Amendment’s, IND safety Report. •Gathered, coordinated, and submitted all the appropriate documents, correspondence, and final reports for the IND and post-marketing annual report to the FDA. •Used statistical software in identifying analytical data trends in support of CMC Regulatory filings. •Helped to procure stability database and incorporate current stability data for physical and chemical parameters for all clinical programs. •Initiated an analytical database and compiled all current method development reports, SOPs, specifications, protocols, method validation, and method reports •Worked on organizing internal and external documents including proposals, Purchase Orders, and invoices. Show less

Research Intern | Experiential Learning (XN)

• Apr 2020 - Jun 2020

Understood commitment to compliantly reach out to educate HCPs about the new drug and how it could help patients . Analyzed communication preferences of HCPs, by identifying trends and opportunities in digital communications that would fit within allotted budget and time constraints. Recommended various strategies, communication approaches and appropriate technologies. Understood commitment to compliantly reach out to educate HCPs about the new drug and how it could help patients . Analyzed communication preferences of HCPs, by identifying trends and opportunities in digital communications that would fit within allotted budget and time constraints. Recommended various strategies, communication approaches and appropriate technologies.

Drug Safety Associate

• Oct 2018 - Jul 2019

Performed case processing for serious adverse events, serious and non-serious adverse drug reactions and other medically related project information. Ensured all sponsors and regulatory timelines are met 100% for processing and safety reporting. Reviewed relevant safety tracking database and assisted with maintaining project files for accuracy and quality. Utilized clinical judgment in coding of verbatim adverse events and medical history with MedDRA, and medications with WHO DD. Evaluated SAE (serious adverse events) and AE (adverse events)/PC (product complaints) reconciliation activities, ensuring completion and closure of cases completed in a timely fashion. Show less

Drug Safety Associate

• Jun 2017 - Dec 2017

Performed triage and classified ICSRs (individual case safety reports) for report type, seriousness, causality, expectedness/labeling and reporting; prioritized ICSRs according to regulatory requirements. Developed a thorough knowledge of products completing the periodic safety update reports on drugs and other treatments. Discussed source documents, coding conventions and ad-hoc queries with concerned POC’s and collaborated with other team members. Performed triage and classified ICSRs (individual case safety reports) for report type, seriousness, causality, expectedness/labeling and reporting; prioritized ICSRs according to regulatory requirements. Developed a thorough knowledge of products completing the periodic safety update reports on drugs and other treatments. Discussed source documents, coding conventions and ad-hoc queries with concerned POC’s and collaborated with other team members.

Summer Intern

• May 2016 - Jun 2016

Observed various equipment and machinery involved in tablets and capsule manufacturing. Learned about the regulatory requirements of the industry, devices and drugs. Developed and learned about documentation of quality assurance department. Observed various equipment and machinery involved in tablets and capsule manufacturing. Learned about the regulatory requirements of the industry, devices and drugs. Developed and learned about documentation of quality assurance department.