Regulatory Strategies Jobs in USA

Rezolute is a late-stage rare disease biopharmaceutical company focused on developing transformative therapies for patients living with severe metabolic and endocrine disorders. Our mission is to bring hope and meaningful solutions to patients and families affected by rare and difficult-to-treat dis...

Job DescriptionSenior Scientist Regulatory CMC Biologics Position Description:Serve as a Regulatory CMC Project Lead and provide CMC Regulatory leadership within Regulatory and on cross-functional teams for the assigned biological projects. Be accountable for the delivery of all regulatory milestone...

Job DescriptionThe Mixed Modalities team within Sterile Product Development is responsible for developing parenteral dosage forms (injections implants inhaled ocular) for small intermediate and large molecules from preclinical toxicology studies to commercialization. Our development teams ensure rob...

Job DescriptionOur companys Quantitative Pharmacology and Pharmacometrics (QP2) Department is seeking a Team Leader (Executive Director) to support our rapidly expanding immunology pipeline.Immunology has been a strategic growth area for our company during the last years including an exciting late-s...

Working with UsChallenging. Meaningful. Life-changing. Those arent words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here uniquely interesting work happens every day in every department. From optimizing a production line to the latest breakthrou...

OverviewThe Manager Regulatory Affairs Global Development supports development and lifecycle regulatory activities across assigned products and clinical programs. This role serves as the Regulatory Affairs lead for assigned projects owning regulatory deliverables and acting as a key point of contac...

Responsible for quality of assigned new product introduction programs to ensure business objectives are met with regards to on time deliverables of program development while assuring compliance with local divisional and corporate policies and external agency regulations worldwide. Products include r...

Full-timeDescriptionJOB PURPOSE: Execute on regulatory strategy of De Novo submissions for AI/ML-based Software as a Medical Device (SaMD) product including AidaBreast. Serve as regulatory lead for novel oncology diagnostic technologies integrating genomic and proteomic biomarkers. Ensure alignment...

Bring more to life.Are you ready to accelerate your potential and make a real difference within life sciences diagnostics and biotechnologyAt Beckman Coulter Diagnostics one of Danahers 15 operating companies our work saves livesand were all united by a shared commitment to innovate for tangible imp...

Master Planning Design Engineer (Drainage & Land Development)Company Name: RTM Engineering ConsultantsLocation: Corona CAIndustry Focus: Residential Land Development Drainage Infrastructure Civil EngineeringWork Setting: Full-Time Integrated Multi-Disciplinary StudioSalary: $70000 $100000 Profi...

Senior Certification Systems Engineer - Regulatory Administration & AirworthinessCompany:The Boeing CompanyThe Enterprise Certification Processes team is seeking a Senior Certification Systems Engineer - Regulatory Administration & Airworthiness to join our team in Everett Washington. If you are a g...

The Director Regulatory Affairs Global Regulatory Lead (GRL I) in Global Regulatory Strategy is responsible for developing and implementing global regulatory strategies to secure and maintain market approval for product(s) in assigned therapeutic area. Leads the Global Regulatory Product Team (GRPT)...

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...

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...

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...

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...

Career CategoryRegulatoryJob DescriptionJoin Amgens Mission of Serving PatientsAt Amgen if you feel like youre part of something bigger its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.Since 1980 weve helped pioneer the world of biotech in o...

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...

VC-25B Certification Integration Engineer (Experienced and SeniorCompany:The Boeing CompanyBoeing Defense Space & Security (BDS) VC-25B program is seeking a Certification Engineer (Experienced and Senior) to integrate unique and ground-breaking compliance activities for the airplanes that will becom...