Emily L. Yin
Hoboken,NJ
Summary
Regulatory Affairs Manager with 10+ years of experience in regulatory operation, clinical development, and public health. Proven success in developing and executing global regulatory strategies, leading end-to-end submissions, and serving as liaison to regulatory agencies. Skilled in managing timelines, vendors, agency interactions, and document workflows. Adept at streamlining regulatory systems and processes using Veeva RIM and Smartsheet. Strong project management and cross-functional leadership across all stages of the product lifecycle. Holds a Certificate in Regulatory Affairs and dual master’s degrees in Public Health and Social Work.
Overview
11
11
years of professional experience
1
1
Certification
Work History
Regulatory Affairs Manager
PATH
01.2024 - Current
- Develop and execute global regulatory strategies to support clinical trial initiation, product development, and lifecycle management in compliance with FDA and international regulatory requirements.
- Lead the planning, preparation, and submission of regulatory filings, including INDs/CTAs, amendments, meeting requests, and briefing packages , ensuring timely, high-quality, and compliant submissions.
- Drive cross-functional collaboration to gather scientific and technical data necessary for the development of submission-ready regulatory documentation.
- Serve as the primary liaison with FDA and global regulatory agencies, drafting formal meeting requests, formulating strategic discussion points, and preparing comprehensive support materials for milestone interactions.
- Manage regulatory timelines and submission tracking for both development-phase and routine submissions, including stability updates, annual reports, and safety communications.
- Lead the development and execution of response strategies for agency deficiencies, defining scope, deliverables, and timelines to support efficient resolution and minimize regulatory delays.
- Serve as the primary point of contact with external vendors to ensure timely, accurate, and compliant delivery of regulatory submission components.
- Monitor evolving regulatory guidance and proactively assess its impact on submission strategy, internal SOPs, and business practices.
- Contribute to the continuous improvement of regulatory systems and processes to enhance submission readiness and operational efficiency.
Specialist, Regulatory Affairs
IAVI
07.2022 - 01.2024
- Supported the planning, preparation, and submission of FDA and international regulatory filings—including INDs, CTAs, amendments, and meeting briefing packages—ensuring accuracy, completeness, and alignment with regulatory requirements.
- Supported the preparation and submission of FDA and global regulatory filings—including INDs, CTAs, amendments, and meeting briefing packages—ensuring content accuracy and regulatory alignment.
- Tracked regulatory timelines and supported milestone management throughout the submission lifecycle, including deficiency rounds and post-approval maintenance activities.
- Reviewed and maintained critical regulatory documents to ensure compliance with regulatory requirements and support change control processes.
- Collaborated with internal teams to ensure regulatory deliverables met internal quality standards and were aligned with evolving global regulatory expectations.
- Oversaw department budget and vendor contracts for regulatory deliverables, ensuring cost-effective, compliant execution of submission-related activities.
- Contributed to process optimization by enhancing document workflows and improving submission-readiness through structured content management in Veeva RIM.
Sr. Associate, Product Development
IAVI
08.2021 - 07.2022
- Provided day-to-day administrative support to VP of Vaccine Development and scientific leadership.
- Coordinated IAVI's R&D weeks, retreats, and workshops, including developing agenda, preparing background materials and slides, and taking meeting minutes.
- Supported development and management of department budgets.
- Processing contracts, invoices, and expense reimbursements for consultants and agencies.
- Assisted PDC establishing new initiatives for operational excellence, such as a streamlined New Hire on-boarding process.
Program Manager
Apicha Community Health Center
09.2020 - 08.2021
- Oversaw the agency's HIV prevention navigation program, funded by local, state, and federal sources.
- Developed essential program documents, including standards, monthly reports, contract monitoring, project schedules, and operational plans.
- Collaborated with senior administration to plan, implement, and monitor logistics for the PrEP and PEP navigation program.
- Initiated and designed community outreach activities to increase PrEP and PEP awareness among high-risk populations.
- Conducted program-related data analysis to support planning and evaluation, presenting findings and recommendations to the executive team.
- Performed quality assurance activities, using data to monitor and ensure timely achievement of program goals.
- Coordinated with stakeholders to facilitate transparent communication on program issues and service decisions.
- Managed administrative tasks, including scheduling, agenda preparation, meeting summaries, and follow-up actions to maintain program timelines.
- Supervised PrEP Navigators and Coordinators.
Public Health Advisor II
New York City Department of Health and Mental Hygiene
08.2018 - 09.2020
- Managed patients with a confirmed or suspected communicable disease to empower appropriate treatment plans are in place.
- Interviewed patients with a communicable disease, and offer information regarding disease transmission and pathogenesis.
- Provided education on a communicable disease to health care providers and patients to promote positive clinical outcomes.
- Conducted field investigation to navigate communicable disease patients to ensure their compliance of treatment.
- Facilitated surveillance activities including collection of specimens and site visits to prevent further spread of the disease.
- Served as a resource to health care providers and patients in assigned cases and fulfill requests as needed.
Social Worker/Care Manager
ACCM/Metna Better Health
04.2017 - 08.2018
- Collaborated with medical and behavioral health professionals to influence appropriate level of care in the community.
- Provided education to members and health care providers to promote specific preventive health interventions.
- Navigated health care and social services in the community to fully meet members' physical and psychological needs.
- Issued service authorizations to providers under company guidelines to make sure members get on time services.
- Developed individualized and cultural competent care plans for the members to meet their medical and social needs.
Social Worker
Richmond Center for Rehab and Specialty Care
11.2015 - 10.2016
- Provided psychosocial assessment to people with disabilities to assess their mental, physical, and emotional status.
- Developed specific care plans based on the individual resilience needs and goals in collaboration with the new community.
- Developed discharge plans to promote a safe transition to the community.
- Planned safe discharges by making appropriate referrals, ordering medical equipment and providing necessary support.
Intern
UNAIDS
08.2014 - 12.2014
- Developed project related documents regarding ending AIDS epidemic and enhancing HIV intervention strategies in China.
- Prepared and reviewed grant budgets, work plans, projects reports, disbursement requests and other project related documentations.
- Monitored and evaluated the progress of projects, communicated with project stakeholders, and took follow-up actions.
- Collected best practice literature data related to the HIV/AIDS field, with a focus on the most progressive ARVs treatments.
- Created presentations on the best HIV/AIDS prevention practices and related issues in developing countries, to community leadership groups, educational institutions, foundations, private entities, and government agencies.
- Provided technical assistance and trainings for community based groups and organizations to future the AIDS zero goal.
Education
Master of Public Health -
Johns Hopkins University
08.2020
Master of Social Work - undefined
Yeshiva University
07.2015
Economics, Psychology; Minor: Mathematics, Business
Indiana University
05.2012
Skills
- Technical Skills: Veeva RIM, Veeva eTMF, Veeva QualityDocs
- Project Management: Smartsheet, Microsoft Project
- Other: Adobe Acrobat, Microsoft Office
Certification
Certificate in Regulatory Affairs (Medical Devices and Pharmaceuticals) by RAPS February 2023
Languages
Chinese (Mandarin)
Native or Bilingual
Timeline
Regulatory Affairs Manager
PATH
01.2024 - Current
Specialist, Regulatory Affairs
IAVI
07.2022 - 01.2024
Sr. Associate, Product Development
IAVI
08.2021 - 07.2022
Program Manager
Apicha Community Health Center
09.2020 - 08.2021
Public Health Advisor II
New York City Department of Health and Mental Hygiene
08.2018 - 09.2020
Social Worker/Care Manager
ACCM/Metna Better Health
04.2017 - 08.2018
Social Worker
Richmond Center for Rehab and Specialty Care
11.2015 - 10.2016
Intern
UNAIDS
08.2014 - 12.2014
Master of Social Work - undefined
Yeshiva University
Economics, Psychology; Minor: Mathematics, Business
Indiana University
Master of Public Health -
Johns Hopkins University
Similar Profiles
Nikki CastilloNikki Castillo
Program Associate at PathProgram Associate at Path
Luoga OswaldLuoga Oswald
Architectural and System Analysis Lead at PATHArchitectural and System Analysis Lead at PATH
SPHIWE RICHARD MHLANGASPHIWE RICHARD MHLANGA
PSH Case Manager at PathPSH Case Manager at Path
Jason D. ScottJason D. Scott
Senior Territory Manager BDPI Vascular at Becton Dickinson (BD)Senior Territory Manager BDPI Vascular at Becton Dickinson (BD)
Rebecca HaneyRebecca Haney
Community Group Director at Hoboken Evangelical Free ChurchCommunity Group Director at Hoboken Evangelical Free Church