Samvel Nazaretyan

About Samvel Nazaretyan

I am a pharmacist with demonstrated success in navigating complex global regulatory pathways, authoring strategic submissions, and managing cross-functional regulatory activities to accelerate clinical development. With hands-on experience in regulatory filing and lifecycle management, I have advanced cell & gene therapy programs across hematology, oncology, and autoimmune disorders. I bring a collaborative, solutions-focused approach to regulatory strategy, integrating CMC, nonclinical, and clinical considerations to guide products from early development through commercialization. By leveraging regulatory intelligence, risk management, and cross-functional leadership, I help align submission strategies with business objectives while ensuring compliance with GCP, GMP, GLP, and evolving international standards.

Experience

1. Senior Associate, Global Regulatory Affairs and Clinical Qa

   Allogene Therapeutics

   Aug 2024 — Present · San Francisco, CA, US

   Serve as a member of the Global Regulatory Affairs and Clinical QA team, driving global submission strategies, lifecycle management, and health authority engagement to advance allogeneic CAR-T candidates in hematology, oncology, and autoimmune programs.• Author, submit, and maintain global regulatory submissions across clinical, CMC, and nonclinical areas, supporting the full product lifecycle and development strategy, including INDs/CTAs, DSURs, Annual Reports, Investigator’s Brochures, amendments, and information requests.• Collaborate with global health authorities (e.g, FDA, EMA, MHRA, etc) through the preparation of briefing documents, meeting packages, and special designation requests, ensuring timely and high-impact communications that advance regulatory objectives.• Develop global regulatory plans, address regulatory issues, health authority queries, and regulatory obligations, with members of the global regulatory team (CMC-RA, medical writing, regulatory operations, clinical quality).• Conduct regulatory intelligence gathering and analyze precedent approvals and prior health authority decisions to inform strategic product direction and risk management.• Review and approve regulatory submissions to ensure quality, accuracy, and compliance with FDA, ICH, GCP, and global regulatory standards.• Partner with subject matter experts to prepare written responses to complex health authority queries.• Represent study-level regulatory activities in study management teams, collaborating with CROs and other external vendors to ensure alignment with regulatory requirements.• Oversee and coordinate ClinicalTrials.gov listing maintenance for pipeline programs, ensuring accuracy and regulatory compliance.• Liaise with publishing vendors to deliver final documents for eCTD submissions, meeting all deadlines and format requirements.

Education

• Portland State University

  Bachelor of Science - BS, Molecular Biology

• USC Alfred E. Mann School of Pharmacy and Pharmaceutical Sciences

  Doctor of Pharmacy - PharmD, Clinical Pharmacy, Pharmaceutical Development