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insitro
South San Francisco, CA, United States
The Opportunity insitro is using machine learning to yield entirely new, clinically actionable insights into critical unmet needs for patients. We aim to "go fast and improve things" across the entire drug development process from platform to pipeline to patients and back again. The VP Regulatory is a unique opportunity to directly improve patien
Job Source: insitroBridgeBio
San Francisco, CA, United States
About Eidos Therapeutics & BridgeBio Pharma Eidos Therapeutics, an affiliate of BridgeBio Pharma, is a Phase 3 developmental-stage biopharmaceutical company focused on addressing the large and growing unmet need in diseases caused by transthyretin, or TTR, amyloidosis, or ATTR. We seek to treat this well-defined family of diseases at their collec
Job Source: BridgeBioBridgeBio
San Francisco, CA, United States
About Eidos Therapeutics & BridgeBio Pharma Eidos Therapeutics, an affiliate of BridgeBio Pharma, is a Phase 3 developmental-stage biopharmaceutical company focused on addressing the large and growing unmet need in diseases caused by transthyretin, or TTR, amyloidosis, or ATTR. We seek to treat this well-defined family of diseases at their collec
Job Source: BridgeBioPeople With Chemistry
San Francisco, CA, United States
Job Title: Head of Regulatory Affairs - Biologics and Dermatology Company Overview: Join a leading biopharmaceutical company at the forefront of innovation in biologics and dermatology. Our client is committed to developing transformative therapies that address unmet medical needs and improve the lives of patients globally. Their is dedicated to
Job Source: People With ChemistryPeople With Chemistry
San Francisco, CA, United States
Job Title: Head of Regulatory Affairs - Biologics and Dermatology Company Overview: Join a leading biopharmaceutical company at the forefront of innovation in biologics and dermatology. Our client is committed to developing transformative therapies that address unmet medical needs and improve the lives of patients globally. Their is dedicated to
Job Source: People With ChemistryNobell Foods
San Francisco, CA, United States
Nobell Foods is creating cheese and other dairy products from plant-derived dairy proteins for the 99% of people who are unwilling to compromise on taste and price. Nobell is made up of a team of passionate scientists, explorers, and storytellers on a mission to radically change the way we make food, so it’s better for you, the animals and the plan
Job Source: Nobell FoodsBridgeBio
San Francisco, CA, United States
Eidos Therapeutics, an affiliate of BridgeBio Pharma, is a Phase 3 developmental-stage biopharmaceutical company focused on addressing the large and growing unmet need in diseases caused by transthyretin, or TTR, amyloidosis, or ATTR. We seek to treat this well-defined family of diseases at their collective source by stabilizing TTR. Our investiga
Job Source: BridgeBioProtocol Link, Inc.
San Francisco, CA, United States
Must have 10+ Years of relevant experience Lead the R&D Quality and Manufacturing team to manage GCP (good clinical practice) and GPV (good pharmacovigilance practices) inspections by global regulatory health authorities. Provide strategies and oversight for global planning-preparations and clinical investigations. Build systems and tools to sup
Job Source: Protocol Link, Inc.San Francisco, CA, United States
Vice President of Quality and Regulatory Affairs
San Francisco Bay Area (Hybrid)
Our client is a cutting edge CAR-T who novel approach dramatically decreases the time and cost associated with manufacturing. This is a newly created position allowing you to get in on the ground floor and eventually build a team beneath you as their indications advance in development.
If you are looking to be at the forefront of revolutionizing the CAR-T cell therapy space don't hesitate to apply and learn more.
Job Summary: As the Vice President of Quality and Regulatory Affairs you will play a pivotal role in ensuring the quality, safety, and compliance of our CAR-T therapies throughout their lifecycle. You will lead the development and implementation of quality and regulatory strategies, establishing processes that adhere to global regulatory requirements and industry best practices. With a focus on continuous improvement, you will drive a culture of quality excellence across the organization, fostering collaboration between quality assurance, regulatory affairs, and other functional areas.
Key Responsibilities:
Develop and execute a comprehensive quality and regulatory strategy aligned with the company's goals and objectives for CAR-T therapies.
Establish and maintain quality management systems (QMS) to ensure compliance with relevant regulations, standards, and guidelines (e.g., FDA, EMA, ICH).
Oversee the preparation and submission of regulatory filings, including INDs, BLAs, and marketing applications, ensuring timely approvals and compliance with regulatory requirements.
Serve as the primary interface with regulatory agencies, representing the company in interactions, meetings, and inspections.
Lead risk management activities, identifying potential quality and regulatory risks and implementing mitigation strategies.
Drive the development and implementation of robust processes for product manufacturing, testing, and release, ensuring product quality and consistency.
Collaborate cross-functionally with R&D, Clinical Development, Manufacturing, and Commercial teams to support product development, clinical trials, and commercialization activities.
Provide oversight of contract manufacturing organizations (CMOs) and other external partners to ensure compliance with quality and regulatory requirements.
Stay abreast of evolving regulatory trends, guidelines, and standards relevant to cellular therapies and proactively assess their impact on the company's operations and strategies.
Lead and support internal and external audits, ensuring timely resolution of findings and implementation of corrective and preventive actions (CAPAs).
Qualifications:
Experience with CAR-T therapies preferred.
Experience with Cell Therapies is also acceptable.
Experience with IND filings.
Leadership experience in quality and regulatory.
Interaction with Health Authorities.
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Email Alert for VP Quality & Regulatory jobs in San Francisco, CA, United States
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