Regulatory Affairs Director, Medical Devices, Molecular Testing and Biomarkers

The Role:Provide worldwide regulatory strategy and oversight to ensure Moderna can describe, and support processes required for commercialization of INT products (i.e., neoantigen selection (next generation sequencing and bioinformatics) as well as related to front end specimen collection. Provide regulatory strategy and oversight for all Moderna Companion...

Job SummaryWe are seeking a highly experienced and skilled Director of Regulatory Affairs and Quality to lead our Regulatory Affairs and Quality teams in the development and execution of compliant regulatory strategies and quality team/QMS responsibilities.Key ResponsibilitiesRegulatory Affairs Strategy and ExecutionDevelop and execute end-to-end regulatory...

The Role:Moderna is seeking a Director of Clinical Biomarkers to serve as a scientific leader and point of contact for clinical teams in the Infectious Disease (ID) space with responsibilities for developing and driving pivotal biomarker plans across clinical stage ID programs. This position reports to Modernas Sr. Director of Infectious Disease, Clinical...

The Role:Moderna is seeking a Clinical Biomarker leader to drive biomarker assay plans across clinical stage oncology programs. This position reports to Modernas Director of Clinical Biomarkers. The Associate Director will work collaboratively across several clinical teams(internal, external CROs) to ensure biomarker assay development strategy, planning,...

Job SummarySarepta Therapeutics is seeking a highly experienced Regulatory Strategy Director to lead our regulatory affairs efforts. As a key member of our team, you will be responsible for developing and implementing regulatory strategies that ensure compliance with global regulations and facilitate the approval of our therapeutic programs.Key...

Job SummaryWe are seeking a highly experienced Senior Director to lead our Regulatory Affairs and Compliance team at Apnimed. As a key member of our leadership team, you will be responsible for developing and executing regulatory strategies to support the approval and commercialization of our therapies globally.Key ResponsibilitiesRegulatory Strategy and...

About the RoleWe are seeking a highly skilled and experienced Regulatory Affairs Director to join our team at GlaxoSmithKline. As a key member of our Global Regulatory Affairs team, you will play a critical role in shaping our regulatory strategy and ensuring compliance with regulatory requirements.Key ResponsibilitiesDevelop and implement regulatory...

Job TitleRegulatory Affairs Senior ManagerJob SummaryPhilips is seeking a highly experienced Regulatory Affairs Senior Manager to lead regulatory projects for Philips Clinical Informatics organization. The successful candidate will play a critical role in ensuring and maintaining global accurate regulatory strategy and market access for Philips Disease...

Job Title: Regulatory Affairs Senior SpecialistJob Description:In light of the pressing challenges our world faces today, the mission of Philips has never been more significant. If you share our commitment to enhancing lives, your contributions will be pivotal in shaping a more equitable future for everyone.In this position, you will have the opportunity...

About the RoleWe are seeking a highly skilled Director of Imaging and Biomarkers to join our Translational Medicine team at BlueRock Therapeutics. As a critical member of our team, you will leverage your expertise in CNS, ophthalmic, and inflammation imaging to advance our development pipeline.Key ResponsibilitiesDevelop Translational Strategies: Design and...

Job TitleSenior Director of Clinical AffairsJob SummaryWe are seeking a highly experienced and skilled Senior Director of Clinical Affairs to join our team at Philips. As a key member of our organization, you will be responsible for delivering clinical knowledge, experience, and expertise across the entire value chain from ideation to end-of-life.Key...

We invite you to become a part of our esteemed pharmaceutical organization as a Senior Director of Global Regulatory Affairs for Pharmaceuticals. In this pivotal role, you will be instrumental in formulating and executing comprehensive regulatory strategies for pharmaceutical products throughout their lifecycle, from development to market launch. Your...

ABOUT QURALISQurAlis is at the forefront of neurobiology, dedicated to pioneering innovative solutions for neurodegenerative diseases. Our mission is to develop precise therapeutic interventions that significantly impact conditions such as amyotrophic lateral sclerosis (ALS) and frontotemporal dementia (FTD). With a foundation built by esteemed...

Why Join Intellia?Our mission is to develop curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases.Beyond our science, we live our four core values: One, Explore, Disrupt, Deliver and feel strongly that you can achieve more at Intellia. We have a single-minded determination to...

The Director of Regulatory Affairs at The Steely Group plays a pivotal role as a liaison with Health Authorities and leads regulatory projects across various development phases. This position demands a strategic regulatory leader who can effectively guide drug development initiatives by leveraging extensive expertise in regulatory frameworks.Key...

The Director of Regulatory Affairs at The Steely Group plays a pivotal role as a liaison with Health Authorities and as a leader in regulatory projects across various development phases. This position is essential for guiding drug development initiatives and leveraging extensive regulatory knowledge to support project teams in navigating complex...

The Director of Regulatory Affairs at The Steely Group plays a pivotal role as a liaison with Health Authorities and leads regulatory projects across various development phases. This position demands a strategic regulatory expert who will guide drug development initiatives, leveraging extensive expertise to inform project teams on compliance requirements and...

ABOUT QURALISQurAlis is at the forefront of neurobiology, striving to revolutionize the treatment landscape for neurodegenerative diseases such as amyotrophic lateral sclerosis (ALS) and frontotemporal dementia (FTD). Our foundation is built on a team of esteemed neurobiologists from Harvard Medical School and Harvard University, dedicated to the discovery...

Position OverviewThe Biomarker Development (BMD) division at Novartis BioMedical Research is in search of a Molecular Imaging Specialist to enhance our Clinical Imaging & Analytics team. This role involves providing strategic, scientific, technical, and operational guidance on the effective application of imaging in pharmaceutical development.This position...

Position OverviewWe invite you to explore the opportunity to join Biogen's esteemed Translational Medicine Biomarkers Imaging team. This role is pivotal in advancing our innovative molecular imaging research initiatives, focusing on the development and assessment of radiotracers and methodologies essential for drug discovery.Key ResponsibilitiesAs a vital...