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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.Hibio
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 TherapeuticsBioSpace
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: BioSpaceMazetx
South San Francisco, CA, United States
Become a genetic navigator. Our mission is to discover new genetic insights and translate them into new precision medicines. With an unparalleled commitment to changing the way people with severe diseases are treated, our team is at the forefront of accelerating our understanding of the genetic drivers of disease. We celebrate a diversity of pers
Job Source: MazetxPulmonx 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 CorporationMaze 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 TherapeuticsCargo 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 TherapeuticsRedwood 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 selective proprietary cortisol modulators and a history of groundbreaking FDA approvals, this company is dedicated to advancing the possibilities of cortisol modulation to treat serious diseases across various therapeutic areas
Role Overview:
As a Regulatory Affairs Sr. Director focused on oncology products, you will lead regulatory strategy, filings, and health authority interactions, providing strategic and operational leadership to support the development of innovative drug products. This role requires a strong understanding of global regulations and extensive experience in regulatory affairs within the biotechnology or pharmaceutical industries.
Responsibilities:
Develop global regulatory plans to support programs in all phases of development, identifying risk mitigation strategies and influencing project teams to maximize regulatory success.
Support efficient conduct of development programs while ensuring compliance with global regulatory requirements and company procedures.
Manage regulatory documents/submissions for IND/CTA and marketing applications.
Prepare for and attend meetings and teleconferences with regulatory agencies.
Monitor changes in global regulations governing drug development and contribute to process improvements.
Preferred Skills and Qualifications:
10+ years of experience in Regulatory Affairs in biotechnology or pharmaceutical industries.
Extensive drug development experience with a focus on regulatory strategies.
Experience preparing global regulatory submissions including INDs, CTAs, and marketing applications.
Familiarity with Electronic Common Technical Document format and regulatory inspection readiness.
Ability to travel to agency meetings (US and international).
Senior management experience with the ability to develop and lead a team.
Excellent verbal and written communication skills.
Preferred Education:
PhD in a scientific discipline, Medical Degree, or PharmD.
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Email Alert for Senior Director Regulatory Affairs jobs in Redwood City, CA, United States
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