Senior Regulatory Affairs Specialist, Pharmaceuticals

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...

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...

Responsibilities and Duties:Responsible for timely planning, coordination, and execution of regulatory submissions to FDA and other jurisdictionsOversee the authoring, review, approval and submission of Clinical, Nonclinical, and CMC documents for regulatory submissionsConduct regulatory review of submission documentsCoordinate with external publishing...

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,...

Formulate regulatory strategies, with supervisor oversight, based on current regulatory intelligence Collaborate with cross-functional project teams and external business partners to develop regulatory strategies, identify regulatory risks and provid Regulatory Affairs, Manager, Regulatory, Senior, Business Partner, 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,...

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...

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...

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...

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

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...

Who is CorDx?CorDx a multi-national biotech organization focused on pushing the limits of innovation and supply in global health. With over 2,100 employees across the world, serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious disease such as COVID-19,...

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...

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...