Associate Director, Regulatory Affairs - San Francisco Bay Area

The Regulatory Affairs Specialist will support regulatory compliance activities by preparing and executing submissions to FDA and other global regulatory agencies. · ...

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The Senior Manager of Regulatory Affairs will provide project teams with regulatory advice and manage various ac ...

This innovative patient-focused commercial-stage biopharmaceutical company based in China and US is seeking a Regulatory Affairs Director who can lead development implementation of regulatory strategy for key oncology asset. · ...

This position provides administrative support for the activities conducted by the Regulatory Affairs Department. · All listed tasks and responsibilities are deemed as essential functions to this position; · however business conditions may require reasonable accommodations for add ...

The Director of Regulatory Affairs will provide regulatory leadership to clinical development programs in oncology. · ...

The Director of Regulatory Affairs is accountable for driving preparation & execution of Regulatory NDA/MAA filings for late-stage oncology programs at RevMed. · ...

+This isn't your typical regulatory affairs position. You'll be teaching AI systems how to think like a regulatory professional. · ...

We're transforming how regulatory documents get written in pharma biotech and medtech through fundamental AI research. · The Role · You'll be teaching AI systems how to think like a regulatory professional evaluating AI-generated content identifying gaps in logic or compliance de ...

The Global Head of Regulatory Affairs for Companion Diagnostics will define and lead the end-to-end global regulatory diagnostic strategy for the company's portfolio. · Define and execute a global companion diagnostic regulatory strategy aligned with the company's precision oncol ...

+Job summary · We're looking for a Regulatory Affairs Consultant to join us and help drive and support our growing regulatory function. · +ResponsibilitiesWe're looking for a Regulatory Affairs Consultant to join us and help drive and support our growing regulatory function. · Yo ...

We are seeking a Director of Regulatory Affairs to drive the preparation and execution of global regulatory NDA/MAA filings for late-stage oncology programs. The successful candidate will have a thorough understanding of oncology drug development, US NDA & global filing regulatio ...

We are a non-profit committed to our participants. Dedicated To The Care Of Elders PACE (Program of All-Inclusive Care for the Elderly) was developed to answer the many problems around caring for frail seniors. Seniors, their family members, and caregivers face many issues... · ...

We are a non-profit committed to our participants. Dedicated to The Care of Elders: PACE (Program of All-Inclusive Care for the Elderly) was developed to answer the many problems around caring for frail seniors. The PACE model is centered on the belief that it is better for the w ...

Proclinical is seeking a Senior Director Regulatory Affairs for a growing and exciting clinical-stage biotechnology company based in the San Francisco Bay Area California. · In this role you will lead global regulatory strategy and operations across the companys development pipel ...

We are seeking a Senior Manager of Regulatory Affairs to provide project teams with regulatory advice and manage various Regulatory Affairs activities within and between departments. The position may also undertake regulatory intelligence and research supporting company decision- ...

Job Summary: · A regulatory representative acts on core product development teams communicating regulatory requirements and impact of regulations to project teams. They provide input related to FDA and international product registrations and licensing requirements. · Maintains an ...

+The Director of Quality and Regulatory Affairs will report directly to the CEO and be responsible for developing, implementing, and maintaining quality systems and regulatory compliance processes in accordance with FDA regulations (21 CFR Part 820) and ISO 13485 standards. · +Ov ...

The Vice President of Regulatory Affairs will define and execute global regulatory strategies for medical devices across the full product lifecycle. · Define and execute global regulatory strategies for medical devices across the full product lifecycle. · Provide strategic regula ...

This is a Regulatory Affairs Manager position supporting preparation review submission CMC sections U.S global regulatory filings INDs CTAs amendments BLAs MAAs coordinating internal stakeholders gather technical information ensure accuracy consistency CMC documentation developin ...

This position supports the preparation review and submission of CMC sections for U.S and global regulatory filings INDs/CTAs amendments and BLAs/MAAs. · ...

We are looking for a Sr Manager Regulatory Affairs who will define the regulatory strategy plans and objectives for assigned products compounds indications or projects in Virology. · Doctorate and 2+ years of relevant experience OR Master's and 6+ years of relevant experience OR ...