Nelson Yang

Senior Director Regulatory Affairs @ Shoreline Biosciences, Inc.

About

I am a regulatory affairs executive with more than 15 years of experience leading global regulatory strategies in the biotechnology and pharmaceutical industries. My career has been defined by advancing cell therapy, oncology, autoimmune, and rare disease programs through complex regulatory pathways, including IND, CTA, BLA, and MAA submissions. I combine strategic foresight with hands-on execution, ensuring that innovative therapies progress seamlessly from preclinical research to commercialization.At Shoreline Biosciences, I direct regulatory strategy for an advanced cell therapy portfolio, guiding submissions, FDA and EMA interactions, and CMC oversight while advising the executive team. Prior to this, I led regulatory operations at Artiva Biotherapeutics, where I managed global submissions and served as regulatory CMC lead for NK cell therapy programs. At Fate Therapeutics, I acted as the primary regulatory liaison for multiple cell therapy candidates, coordinating INDs, Safety Reports, orphan drug applications, and health authority meetings. My earlier experience with Custopharm and Biogen Idec sharpened my expertise in INDs, ANDAs, 505(b)(2) submissions, lifecycle management, and compliance for GLP laboratories.I bring a proven record of success in working with regulatory authorities worldwide, including FDA and EMA, to achieve program alignment and expedite approvals. My leadership approach emphasizes collaboration, compliance, and strategic agility, enabling me to partner effectively across functions and with senior leadership. I am passionate about contributing to organizations that push the boundaries of science to deliver meaningful therapies to patients.

Country

United States

City

San Diego Metropolitan Area

Industry

Biotechnology

Skill

SOP Development, GLP Compliance, Audit Management, Regulatory Oversight, Technical Support, Software Support, Regulatory Compliance, FDA Submissions, Post-Approval Regulatory Strategy, 505(b)(2) Strategy, NDA and ANDA submissions, Orphan Drug Applications, Health Authority Engagement , IND Preparation, Cross-functional Collaborations, Clinical Trial Support, CMC development, Cell and Gene Therapy, Regulatory Strategy, Global Health Authority Engagement

Experience

Senior Director Regulatory Affairs

Shoreline Biosciences, Inc.

2024-10 - 2025-10 · 1 yr 1 mo

San Diego, CA

I lead regulatory department for Shoreline’s cell therapy portfolio, guiding the company through agency interactions, compliance oversight, and global program advancement. My responsibilities include preparing INDs and CTAs, directing briefing packages for FDA and EMA meetings, and supporting cross-functional teams in manufacturing, quality, and development. I advise the executive leadership team on regulatory strategy for both internal and partnership programs, maintain expertise in global regulations, and implement processes that ensure compliance across the organization.

Director of Regulatory Affairs

Artiva Biotherapeutics

2020-7 - 2024-10 · 4 yrs 4 mos

San Diego, CA

I directed regulatory strategy and operations for NK cell immunotherapy programs, overseeing global submissions and ensuring compliance with U.S. and ex-U.S. requirements. I served as regulatory CMC lead, collaborating with manufacturing and quality teams to align technical and regulatory expectations. I also participated in inspections and quality audits with partners, ensuring regulatory readiness. This role required continuous coordination with cross-functional teams to deliver successful submissions and advance programs through key milestones.

Senior Manager Regulatory Affiars

Fate Therapeutics Inc.

2016-5 - 2019-6 · 3 yrs 2 mos

San Diego

I served as the lead regulatory strategist and agency contact for multiple cell therapy candidates, advancing programs in oncology and rare diseases. I developed and executed submission plans, managed preparation of INDs, Safety Reports, Investigator Brochures, and orphan drug applications, and coordinated cross-functional teams to deliver complete and timely submissions. I advised senior leadership on regulatory developments and ensured alignment with FDA and international health authorities.

Director of Regulatory Affairs

Custopharm

2014-8 - 2019-6 · 4 yrs 11 mos

San Diego, CA

I directed regulatory strategy and lifecycle management for pharmaceutical development programs and marketed products. I managed INDs, ANDAs, and 505(b)(2) applications, supervised lifecycle activities such as supplements and annual reports, and worked directly with FDA to resolve regulatory issues. My role ensured that client programs met regulatory requirements while advancing through key milestones.

Regulatory Affairs Manager

Custopharm, Inc.

2013-4 - 2014-8 · 1 yr 5 mos

Carlsbad, CA

I managed regulatory submissions and compliance activities for sterile injectables, oral solutions, ophthalmics, and drug-device combination products. This included INDs, 505(b)(2), and 505(j) submissions, as well as responding to FDA deficiencies and complete response letters. I also oversaw annual reports and supplements and contributed to the development of proprietary eCTD publishing software that streamlined submission processes.

Regulatory Affairs Associate

CustoPharm, Inc.

2012-10 - 2013-2 · 5 mos

Carlsbad, CA

Regulatory compliance Manager

Biogen

2009-2 - 2012-4 · 3 yrs 3 mos

San Diego, CA

I oversaw compliance functions for GLP and clinical assay laboratories, supporting audits, gap analyses, and change control activities. I coordinated internal and external audits, ensured CRO compliance, and authored SOPs, validation protocols, risk assessments, and deviations. This role strengthened inspection readiness and process improvements across the laboratory environment.