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ALX Oncology Inc.
South San Francisco, CA, United States
ALX Oncology is a clinical-stage immuno-oncology company focused on helping patients fight cancer by developing therapies that block the CD47 checkpoint pathway. Our lead candidate, evorpacept, is a next-generation CD47 blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated proprietary Fc domain. For more informa
Job Source: ALX Oncology Inc.Meet
Redwood City, CA, United States
Exciting Opportunity in Regulatory Affairs - Sr. Director Location: Redwood City, CA (Onsite 3 days per week) Company Overview: A pioneering biotechnology company, at the forefront of cortisol modulation research and development, is seeking a dynamic Regulatory Affairs Sr. Director to join their innovative team. With a robust pipeline of over 1,000
Job Source: MeetHibio
South San Francisco, CA, United States
JOB TITLE: Senior Director, Regulatory Affairs DEPARTMENT: Regulatory Affairs TYPE: Full-Time HI-Bio, Inc. is a clinical-stage biotechnology company based in South San Francisco, California. Our shared purpose is to transform the lives of patients with severe immune-mediated diseases by developing novel targeted therapies with outsized clinical imp
Job Source: HibioCargo Therapeutics
San Carlos, CA, United States
Description The Director, Regulatory Affairs will be responsible for providing global regulatory leadership in support of the development, registration, and lifecycle management of CARGO's oncology products. They will ensure effective achievement of regulatory/business objectives across teams, within the department, and at the corporate level. The
Job Source: Cargo TherapeuticsPulmonx Corporation
Redwood City, CA, United States
The Director of Regulatory Affairs will support product development, registration, and post market support activities, in addition to managing a small team of Regulatory Affairs Associates and directing their work as it relates to the activities outlined below. Support Product Development & Registration: Provides strategic input and technical g
Job Source: Pulmonx CorporationCargo Therapeutics
San Carlos, CA, United States
Description The Director, Regulatory Affairs will be responsible for providing global regulatory leadership in support of the development, registration, and lifecycle management of CARGO's oncology products. They will ensure effective achievement of regulatory/business objectives across teams, within the department, and at the corporate level. The
Job Source: Cargo TherapeuticsMaze Therapeutics
South San Francisco, CA, United States
The Position: Join our dynamic Regulatory Affairs team as a Director, Regulatory Affairs, where you will be the driving force behind our development programs from preclinical candidate designation through drug approval. We are looking for a strategic thinker and regulatory expert to provide leadership and guidance. As the Global Program Lead, you
Job Source: Maze TherapeuticsPulmonx
Redwood City, CA, United States
Responsibilities: The Director of Regulatory Affairs will support product development, registration, and post market support activities, in addition to managing a small team of Regulatory Affairs Associates and directing their work as it relates to the activities outlined below. Support Product Development & Registration: Provides strategic input a
Job Source: PulmonxRedwood City, CA, United States
Senior Director, Regulatory Affairs (Generalist)
Hybrid Role - 3 Days in Menlo Park, CA
Meet is partnering with a late stage pediatric rare disease startup looking for a high-level Regulatory Affairs professional to join their team. This position will be reporting into the SVP of Regulatory Affairs and will be supporting Clinical Regulatory and Regulatory CMC functions. Our client recently reported positive P3 data for their lead drug candidate and is in the process of filing an NDA this year.
Key Responsibilities:
Carry out Reg Strategy and Reg CMC functions to support major Regulatory submissions
Serve as a cross-functional leader within the organization to facilitate prompt and accurate regulatory documentation
Key Qualifications/Requirements
9+ years of Regulatory Affairs (mix of Clinical Reg and Reg CMC highly preferred)
NDA/late stage experience highly preferred
Small molecule development experience required
Startup experience highly preferred
Please feel free to reach out directly to Ryan Moran to learn more:
Email Alert for Senior Director Regulatory Affairs jobs in Redwood City, CA, United States
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