Regulatory Submissions Jobs in USA

Regulatory Affairs SpecialistFridleyAbout HeraeusMaking displays foldable Helping hearts beat with medical innovations Or breathing new life into precious metals As a family-owned global technology group we help our customers to always being one step ahead.About Heraeus MedevioTogether we improve li...

Work Flexibility: Hybrid or OnsiteSenior Staff Regulatory Affairs SpecialistIrvine CaliforniaAs a Senior Staff Regulatory Affairs Specialist you will influence global regulatory strategy across the full product lifecycle while partnering closely with product development quality and clinical teams. T...

About The RoleThe Staff Regulatory Affairs Engineer is the primary regulatory strategist and architect for our AI/ML Software as a Medical Device (SaMD) portfolio. While many companies view Regulatory Affairs as a purely administrative function at Hinge Health we leverage this role as a technical di...

Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The companys R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. The companys RAS(ON) inhibitors daraxonra...

This role focuses on the analytical characterization of biotherapeutics from clinical through commercial stages with a strong emphasis on antibodies proteins and peptides. The work involves applying a range of analytical techniques for size and charge variant analysis and interpreting protein post-t...

Location:4900 Tiedeman Road Brooklyn OhioPosition SummaryKey is seeking a detail-oriented and proactive Senior Management Reporting Analyst Regulatory Reporting Governance to support the governance oversight and quality assurance of enterprise regulatory reporting processes. This role will play a c...

Principal Cybersecurity Engineer for Whippany NJ to define project-level cybersecurity requirements; design & develop security solutions to mitigate product cybersecurity risks; understand medical device products & clinical applications to identify potential cybersecurity threats and develop mitigat...

Senior Manager Regulatory Systems EngineeringRadiant is seeking an experienced Engineering Manager who loves to think outside the box and challenge convention; in this role you will lead the authorization process for reactor deployment with our military partners. You will be responsible for regulato...

Regulatory EngineerRadiant is seeking a driven Regulatory Systems Engineer who loves to think outside the box and challenge convention; in this role you will support the license application approval process with the Nuclear Regulatory Commission. This role is critical to bringing the worlds first po...

Job SummaryAre you passionate about innovation that transforms everyday products into extraordinary experiencesIFF is a global leader in flavors fragrances food ingredients and health & biosciences we deliver sustainable innovations that elevate everyday products.Health & Biosciences: Channeling our...

The Task At Hand:Were building the compliance infrastructure behind some of the most exciting brands in the beverage and wellness space - and we need someone who can own the work.This role reports directly to the Compliance Manager and supports regulatory and certification operations across three di...

Were here for one reason and one reason only to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. Weve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we...

We are looking for anEngineerto join ourAutologous CAR-TCellTherapy Process Development this roleyoullbe instrumental in supporting the development of a clinical manufacturing process ofautologousCAR-T products.Summary of the group:The Autologous CART Process Development team within Cell Therapy De...

Why Work at RehlkoOur work is guided by our purpose: creating an energy-resilient world for a better future. This purpose embodies the legacy we bring with more than 100 years as the global leader in energy resilience delivering solutions critical to sustain and improve life. Our teams have the op...

At Gilead were creating a healthier world for all people. For more than 35 years weve tackled diseases such as HIV viral hepatitis COVID-19 and cancer working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight aga...

Kyowa Kirin is a global specialty pharmaceutical company committed to improving the lives of patients. Kyowa Kirin Inc. the U.S. operating entity is expanding its North American footprint by building its first U.S. manufacturing facility in Sanford North Carolina (Sanford) a greenfield site currentl...

At Gilead were creating a healthier world for all people. For more than 35 years weve tackled diseases such as HIV viral hepatitis COVID-19 and cancer working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight aga...

We anticipate the application window for this opening will close on - 19 May 2026At Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all. Youll lead with purpose breaking down barriers to innovation in a more connected c...

Job Title: Senior Clinical Scientist Oncology Location: Remote (PST working hours preferred) Type: Contract (Initial 3 months with potential extension) Job Summary: We are seeking a Senior Clinical Scientist to support late-stage oncology programs within a clinical-stage biopharmaceutical env...

The Manager Regulatory Affairs Device works with internal and external partners to deliver products to patients. Prepares device regulatory strategies that enable first pass approvals under limited management supervision. Develops and manages content strategy for global regulatory submissions includ...