Annie H. Marcelin
Carlsbad,CA
Summary
Senior Regulatory Affairs professional with experience spanning academic oncology research, global clinical development, and pharmaceutical regulatory operations across biotech and rare disease programs. Experienced supporting global regulatory strategy, IND/CTA submissions, lifecycle management, health authority interactions, and cross-functional development execution across U.S. and ex-U.S. regions. Background includes oncology, neurology, gastroenterology, and rare disease programs across clinical and commercial-stage development. Known for aligning regulatory operations with strategic program objectives, supporting complex global submissions, and driving regulatory readiness in fast-paced environments.
Overview
19
19
years of professional experience
Work History
LEAD, REGULATORY OPERATIONS (CONTRACTOR)
Ionis Pharmaceuticals, INC.
Carlsbad, CA
03.2023 - 03.2026
- Led regulatory operations activities for global clinical trial teams and supported cross-functional execution of regulatory submissions across multiple development programs, aligning clinical, CMC, and regulatory deliverables.
- Contributed to global IND strategy and execution, including preparation, review, and submission coordination.
- Partnered with regulatory program leadership to align submission strategy, identify risks, and ensure readiness for health authority interactions.
- Oversaw vendors and publishing activities, ensuring accurate, timely, and compliant regulatory submissions aligned with evolving regulatory requirements.
- Supported global regulatory strategy and lifecycle activities across U.S. and ex-US regions, contributing to health authority submissions, inspection readiness, and cross-functional development planning.
MANAGER, GLOBAL REGULATORY AFFAIRS (CONTRACTOR)
Takeda Oncology
Cambridge, MA
07.2019 - 07.2022
- Provided global regulatory strategy and operational support across oncology, rare disease, and gastroenterology programs in alignment with FDA, ICH, and GCP requirements.
- Supported global regulatory strategy and lifecycle management activities across U.S. and ex-US regions, including MAA-related initiatives.
- Coordinated regulatory responses and briefing support for health authority interactions and agency information requests.
- Led preparation and coordination of complex global regulatory submissions, including INDs, CTAs, and lifecycle submissions for U.S. and ex-US markets.
- Partnered with Global Regulatory Leads and cross-functional teams to support regulatory planning and execution for high-complexity programs.
- Served as a primary regulatory liaison with internal stakeholders, CROs, and regulatory partners to support development timelines and compliance activities.
- Contributed to periodic safety reporting activities, including PBRERs and DSURs, supporting ongoing global benefit-risk evaluation and regulatory compliance.
PROJECT MANAGER, Gynecologic Oncology Research
UMASS Memorial Medical Center
Worcester, MA
07.2007 - 07.2019
- Deliver a wide range of project management, leadership, and research support for the Division of Gynecologic Oncology.
- Led oncology clinical and translational research programs within a major academic medical center, ensuring regulatory, ethical, and operational compliance.
- Managed gynecologic oncology clinical trial operations across the full study lifecycle, partnering with investigators, sponsors, and institutional leadership.
- Supported IRB and institutional governance activities, contributing to protocol review, patient safety oversight, and regulatory compliance.
- Supported audit readiness, regulatory compliance, CAPA activities, and operational process improvements across oncology research programs.
Education
Doctoral Coursework - Public Health (Community Health)
Walden University
MS - Clinical Research Organization and Management
Drexel University College of Medicine
B.S. - Biology with a concentration in Exercise Science
Fitchburg State College
Skills
- Global Regulatory Strategy Support
- FDA, EMA, APAC, HC & Global Health Authority Interactions
- Cross-Functional Leadership
- IND/CTA/BLA/MAA Lifecycle Management
- ECTD Publishing
- Global Submissions
- Regulatory Operations
- EU CTR & ex-US Submissions
- PBRER
- DSUR
- PSUR
- Safety Reporting
- Inspection Readiness
- Compliance
Timeline
LEAD, REGULATORY OPERATIONS (CONTRACTOR)
Ionis Pharmaceuticals, INC.
03.2023 - 03.2026
MANAGER, GLOBAL REGULATORY AFFAIRS (CONTRACTOR)
Takeda Oncology
07.2019 - 07.2022
PROJECT MANAGER, Gynecologic Oncology Research
UMASS Memorial Medical Center
07.2007 - 07.2019
B.S. - Biology with a concentration in Exercise Science
Fitchburg State College
MS - Clinical Research Organization and Management
Drexel University College of Medicine
Doctoral Coursework - Public Health (Community Health)
Walden University