Yannie Meletopoulos
Sr Director Regulatory Cmc @Ultragenyx
Signup · Get unlimited contacts
WORK HISTORY
Sr Director Regulatory Cmc @Ultragenyx
Regulatory CMC Lead for a late-phase biologics program, accountable for CMC strategy and execution supporting BLA readiness, agency engagement, and post-approval lifecycle planning.• Led authoring and adjudication of BLA CMC sections in close collaboration with internal SMEs and multiple CMOs, ensuring submission quality, consistency, and regulatory alignment.• Mitigated CMC regulatory risk by leading successful FDA Breakthrough Therapy Designation (BTD) and EMA PRIME interactions, securing alignment on key CMC topics.• Enabled accelerated post-approval manufacturing scale-up and scale-out by defining forward-looking Regulatory CMC strategy aligned with supply and demand projections.• Filed multiple major global CMC clinical amendments (US, EU, Canada) in parallel with BLA preparation, achieving approvals with minimal agency questions and no impact to BLA timelines.• Department lead for implementation of a Module 3 core dossier framework in Veeva, establishing a reusable global CMC dossier model across regions and modalities.
EDUCATION
Humber College
RAC, Regulatory Affairs
University of Toronto Mississauga
Bachelor of Science - BS, Chemistry, Biology
SKILLS
ABOUT YANNIE MELETOPOULOS
I am passionate about delivering innovative solutions that address unmet medical needs and improve patient outcomes. I collaborate with cross-functional teams, external partners, and health authorities to ensure compliance with quality, safety, and efficacy standards. I also mentor and coach junior staff, fostering a culture of excellence and continuous learning.
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.