Julia Edwards

SVP, Global Regulatory Affairs - CMC and Devices @ Eli Lilly and Company

About

I am a passionate leader committed to shaping the future of medicine by harmonizing regulatory excellence with biopharmaceutical innovation. With over two decades of experience in global Regulatory Chemistry, Manufacturing, and Controls (CMC), I specialize in bridging groundbreaking science with strategic, compliant pathways to bring transformative therapies to patients worldwide. At the core of my career is a dedication to solving complex challenges—whether pioneering agile regulatory strategies, guiding global teams across diverse markets, or ensuring seamless lifecycle management for innovative biologics and synthetic molecules. From early development to post-market management, I strive to align regulatory rigor with scientific ingenuity to accelerate access to life-changing medicines. As Senior Vice President at Genentech, I led a global team of 350+ professionals across nine countries, driving regulatory strategies for one of the world’s most diverse and impactful therapeutic portfolios. Beyond my corporate role, I serve as a leader within CASSS, shaping the dialogue between industry, academia, and regulatory authorities to advance the future of biopharmaceuticals. My vision is clear: To foster innovation, collaboration, and precision, ensuring life-saving therapies reach those in need swiftly and effectively. Key Areas of Expertise ⚙️ Global Regulatory Strategy: Expertise in end-to-end CMC submissions and compliance for biologics, synthetic molecules, and combination products. 🌱 Leadership & Operational Excellence: Skilled in managing global teams (350+ members) across regions, driving agility and operational efficiency. 💡 Biopharmaceutical Innovation: Pioneering new approaches to lifecycle management, regulatory policy, and advanced manufacturing. 👩‍🔬 Professional Society Leadership: Active leader in CASSS, driving industry dialogue and best practices in biopharmaceuticals. 🤝 Cross-Functional Collaboration: Partnering with manufacturing, R&D, and clinical teams to align regulatory strategy with business goals.

Country

United States

City

South San Francisco

Industry

Biotechnology

Skill

GMP, Strategy, Pharmaceutical Industry, Biotechnology, Leadership, Biopharmaceuticals, Validation, Life Sciences, SOP, Regulatory Affairs, FDA, Technology Transfer, Drug Development, Cross-functional Team Leadership, Oncology, Pharmaceutics, Regulatory Submissions, Management, Therapeutic Areas, Biologics

Experience

SVP, Global Regulatory Affairs - CMC and Devices

Eli Lilly and Company

2025-4 - Present · 1 yr 6 mos

Indianapolis, Indiana, United States

Senior Vice President, Global Head Pharma Technical Regulatory (PTR)

Genentech

2024-4 - 2025-4 · 1 yr 1 mo

United States

-Lead a global organization of 350 professionals spanning 9 countries, accountable for regulatory CMC submissions, compliance, and strategy for Roche’s extensive product portfolio. -Oversee all regulatory CMC aspects, including biologics, synthetic molecules, peptides, and combination products. -Ensure regulatory compliance across Roche’s global manufacturing network, including clinical and commercial facilities, contract manufacturers, and strategic partners.

Vice President

Genentech

2021-9 - 2025-4 · 3 yrs 8 mos

South San Francisco, California, United States

Head global organization accountable for regulatory submissions supporting the biologics drug development lifecycle early development, initial marketing authorizations, and launch.

Global Head, Biologics Marketed Products, Pharma Technical Regulatory

Genentech

2020-1 - 2021-9 · 1 yr 9 mos

South San Francisco, CA

As Global Head of the Pharma Technical Regulatory (PTR) Biologics Marketed Product team, I am accountable for the end-to-end regulatory value-chain that ensures Roche/Genentech's portfolio of life-saving medicines get to patients.

Principle Regulatory Program Director, Chief of Staff, Biologics Marketed, PTR

Genentech

2019-4 - 2020-1 · 10 mos

South San Francisco, CA

Individual contributor responsible for senior strategic review and input to product regulatory plans for biologics products; Chief of Staff accountable for Biologics Marketed business cadence, optimization, and functional management.

Executive Director, Global Regulatory Affairs, CMC

Allergan

2017-3 - 2019-3 · 2 yrs 1 mo

Orange County, California Area

Head team accountable for small molecule and drug/device combination programs including ophthalmic topical solutions, extended release technologies, and solid oral dosage forms at all phases of development.

Director, Regulatory Affairs, CMC

Biogen

2015-1 - 2017-3 · 2 yrs 3 mos

Cambridge, MA

Headed Regulatory CMC Biologics team consisting of 14 Global Regulatory Leads located at multiple US and EU sites accountable for the preparation of regulatory strategy and submissions, leadership of Health Authority engagements, and implementation of functional support processes.

Director, Regulatory CMC

Genentech

2000 - 2014 · 14 yrs

South San Francisco

Started at Genentech as a Chemical Engineer in Manufacturing Science in 2000. Transitioned to Regulatory CMC in 2003. Progressed to Group Director in 2013 and developed a team accountable for the global South San Francisco Marketed Product portfolio with an emphasis in high-volume oncology products, a variety of therapeutic proteins and dosage forms, and innovative regulatory strategies.