Sr. Manager Regulatory Affairs - San Rafael

The Senior Regulatory Affairs Manager is responsible for clinical and nonclinical aspects of domestic and international regulatory affairs to support global commercialization efforts and life-cycle management for multiple commercial programs. · ...

The Global Regulatory Affairs (GRA) is responsible for obtaining approval for new products and ensuring that approval is maintained throughout the product lifecycle. · The Manager supports Global Reg Teams in the development and execution of global nonclinical / clinical regulato ...

The Manager supports Global Reg Teams in the development and execution of global nonclinical / clinical regulatory strategies through a program's lifecycle. · ...

We are seeking an experienced Regulatory Affairs Project Manager to join our team · The ideal candidate will have strong project management skills and experience in the pharmaceutical industry. · Manage Global Regulatory Team operations. · Create and maintain Regulatory timelines ...

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. · ...

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 ...

+Job summary · The Regulatory Affairs Specialist supports global regulatory activities for a diagnostic product portfolio under the guidance of senior regulatory staff. · +Foundational understanding of regulatory requirements for medical devices or diagnostics. · Familiarity with ...

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

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

+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 ...

+Job summaryAs Director Regulatory Affairs you will lead development execution regulatory strategies assigned assets ensuring alignment coordination regions This role collaborates closely other regulatory team members prepare manage submissions leads interactions health authoriti ...

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 ...

· Septerna is seeking an experienced Director of Regulatory Affairs to lead regulatory strategy and execution across discovery programs. · ...

The Director, Regulatory Affairs is responsible for leading the development and execution of regulatory strategies for assigned assets. · ...

Vaxart is a clinical-stage biotechnology company developing oral recombinant vaccines based on its proprietary delivery platform. · Assist in compiling regulatory submissions. · Maintain document control and archive management. · ...

The Regulatory Affairs Specialist supports global regulatory activities for a diagnostic product portfolio under the guidance of senior regulatory staff. · This role assists with preparing and maintaining regulatory documentation, · supporting product registrations and post‑marke ...

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 ...

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... · ...

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 ...

This position supports the plan-wide HIPAA program and Fraud Waste and Abuse (FWA) program under supervision of Regulatory Affairs Compliance leadership acting as liaison between plan regulatory agencies coordinating daily efforts investigations potential privacy FWA related inci ...