Senior Manager, Regulatory Affairs

Job SummaryThe Living Therapeutics Initiative seeks a highly motivated Regulatory Affairs Senior Manager to manage the regulatory affairs, author and assemble IND applications, and help manage FIH studies advancing UCSF-developed cellular therapy candidates. The successful candidate will work in a dynamic academic environment, working across various...

The Regulatory Affairs Analyst will support and obtain human subjects and safety committee approvals for oncology clinical trials supported by the HDFCCC CRSO. The analyst works independently, under the direction of the Regulatory Affairs Manager, to Regulatory Affairs, Analyst, Regulatory, Healthcare, Business Services, Manager

Prepare and/or coordinate and comply routine regulatory submissions and other correspondence in accordance with regulatory agency regulations and guidelines Review regulatory documents to ensure that all submissions are complete, accurate and meet re Regulatory Affairs, Regulatory, Associate, Business Services

Here, we provide our RA/ QA team the opportunity to learn new things, as well as endless growth opportunities If you are interested in working at one of the World's Best Workplaces, Regulatory Affairs, Pharmaceutical, Specialist, Regulatory, Remote, Senior, Manufacturing, Technology

MISSIONMirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases affecting children and adults. Propelled by our passion for patients and their families, we're focused on turning possibilities into realities. Using data and meaningful evidence, our goal is to transform scientific discoveries into therapies...

Work LocationCorporate Headquarters (South San Francisco, CA) – OnsitePosition SummaryThe Vice President/Senior Vice President, Medical Affairs will be a leader of the global medical affairs function to be built and grown at Annexon Biosciences. This role will ultimately be responsible for representing Annexon Biosciences with a network of external thought...

Work LocationCorporate Headquarters (South San Francisco, CA) – OnsitePosition SummaryThe Vice President/Senior Vice President, Medical Affairs will be a leader of the global medical affairs function to be built and grown at Annexon Biosciences. This role will ultimately be responsible for representing Annexon Biosciences with a network of external thought...

Overview:Responsibilities: Manages team of regulatory and clinical professionals at the Specialist or Manager levels Establishes and executes regulatory and clinical strategies, in cooperation with crossfunctional project teams. Provides guidance to staff on identification of regulatory and clinical requirements and supports staff with the effective...

Vir Biotechnology, Inc. is an immunology company focused on powering the immune system to transform lives by treating and preventing infectious diseases and other serious conditions, including viral-associated diseases. Vir has assembled two technology platforms that are designed to modulate the immune system by exploiting critical observations of natural...

Supports Regulatory post-market sustaining and operations management for medical device hardware, software, and accessories. Responsible for ensuring medical device compliance with all global applicable regulations for regulatory projects to meet cor Regulatory Affairs, Regulatory, Specialist, Operations, Product Development, Healthcare, Business Services,...

Job TitleRegulatory Affairs SpecialistJob DescriptionLooking at the challenges the world is facing today Philips' purpose has never been more relevant. So, whatever your role, if you share our passion for helping others, you'll be working towards creating a better and fairer future for all.In this role you have the opportunity toPosition is needed to support...

Job TitleRegulatory Affairs SpecialistJob DescriptionLooking at the challenges the world is facing today Philips' purpose has never been more relevant. So, whatever your role, if you share our passion for helping others, you'll be working towards creating a better and fairer future for all.In this role you have the opportunity toPosition is needed to support...

Principal Regulatory Affairs Specialist, Software (U.S. Hub based)Clinical Integration and Insight (CII) is revolutionizing healthcare delivery at the point of care. Our Capsule Surveillance product is a cutting-edge clinical decision support software medical device (SaMD) that utilizes patented smart rules to provide actionable alerts to clinicians,...

Senior Director, Clinical Affairs - Diagnostic Solutions San Diego, CA, United States Essential Duties and Responsibilities The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs. Participates in corporate development of methods, techniques and...

Join a team that is changing millions of lives. Transforming smiles, changing lives. At Align Technology, we believe a great smile can transform a person's life, so we create technology that gives people the confidence to take on whatever's next. We revolutionized the orthodontic industry with the introduction of the Invisalign system, and we have never...

Alvarez & Marsal (A&M) is a premier, independent, global professional services firm specializing in advising organizations on solving complex business problems, including turnaround management, restructuring, operational and financial performance improvement, strategy and value creation. The Healthcare Industry Group, a subsidiary of A&M, is at the...

Job TitlePrincipal Regulatory Affairs Specialist-Coronary VascularJob DescriptionThe Principal Regulatory Affairs Specialist will play a critical role in ensuring our Coronary Vascular products are safe, reliable, and compliant with global regulatory standards through team leadership and providing regulatory guidance for Sustaining and New Product...

Job TitlePrincipal Regulatory Affairs Specialist-Coronary VascularJob DescriptionThe Principal Regulatory Affairs Specialist will play a critical role in ensuring our Coronary Vascular products are safe, reliable, and compliant with global regulatory standards through team leadership and providing regulatory guidance for Sustaining and New Product...

Job TitlePrincipal Regulatory Affairs Specialist-Coronary VascularJob DescriptionThe Principal Regulatory Affairs Specialist will play a critical role in ensuring Philips Image-Guided Therapy Devices (IGTD) Coronary Vascular (CV) products are safe, effective, and compliant with global regulatory rules and standards. Your role: Advise internal stakeholders...

Summary:We believe in the endless power of people when they come together. But we also believe strongly in our responsibility to minimize harm and keep people safe. In this role, you will be responsible for executing global and domestic Public Affairs marketing campaigns around high-priority topics related to integrity, responsibility, elections,...