Regulatory Submissions Jobs in USA

THE POSITION: The Director Legal & Compliance Business Enablement and Analytics is a senior business enablement leader embedded within the Chief Legal and Compliance Office. This role serves as a trusted and reliable knowledge resource and executor for the Legal and Compliance organization with a st...

Job Title: Project Engineer III Location (On-site Remote or Hybrid): Anasco PR (onsite) Contract Duration: Contract until 02/22/2027 Description: Facilities Process Engineer for Facilities Projects experience in pharma bio tech med device must have facility validation experience HIPPA filtrat...

Discover Your Career at Emory UniversityEmory University is a leading research university that fosters excellence and attracts world-class talent to innovate today and prepare leaders for the future. We welcome candidates who can contribute to the excellence of our academic community.DescriptionThe...

This role is a Principal Engineer position in the Drug Delivery Systems and Packaging (DDSP) department within CSL this role you will be responsible for bringing new Drug Delivery Systems through the development process. You will have considerable cross-functional interactions that include Quality...

Associate Director Tech Transfer and External PartnershipsPosition Description Summary: The Associate Director of Technology Transfer & External Partnerships leads the planning and execution of technology transfer activities to external partners including CDMOs CMOs and strategic collaborators. This...

The Opportunity:This role is a leadership position in the Drug Delivery Systems and Packaging (DDSP) department within CSL TechOps.The ideal candidate has a solid track record in pharmaceutical primary packaging development with hands-on experience in technical review and trade-off discussions.You a...

Company OverviewEmbark on an enriching journey with PROCEPT BioRobotics where our vision mission and values guide everything we do as a company. At PROCEPT we put the patient first in everything we do andare committed to revolutionizing treatment for benign prostatic hyperplasia (BPH otherwise known...

PurposeThe Associate Director Regulatory Affairs Chemistry Manufacturing and Controls (CMC) works with internal and external partners to deliver products to patients. Prepares CMC regulatory strategies that enable first pass approvals. Develops and manages content strategy for regulatory submissions...

This role combines leadership of the General Ledger (GL) function with full oversight of U.S. and Canadian statutory reporting. The GL & Statutory Reporting Manager is responsible for ensuring accurate monthly close quarterly IFRS 17 group reporting sound U.S. GAAP and local statutory accounting and...

Primary Function of PositionThis role will support our global Cardiac Surgery Program. This role is a Director-level Regulatory Affairs leader who will work with business unit leaders clinical teams reimbursement teams to define and execute global cardiac regulatory strategy leads a cross-functional...

Clinical Supply Strategy & PlanningDevelop and execute global clinical supply strategies across Phase 1Phase 3 clinical development programs.Translate clinical protocols and enrollment assumptions into supply forecasts and operational supply plans.Design supply strategies for complex trials includin...

About Acadia PharmaceuticalsAcadia is committed to turning scientific promise into meaningful innovation that makes the difference for underserved neurological and rare disease communities around the world. Our commercial portfolio includes the first and only FDA-approved treatments for Parkinsons d...

Posting SummaryProvide clinical research coordination and regulatory support to the Vaccine Testing Center ( VTC ) with primary responsibility for non-local clinical research studies. The Clinical Research Coordinator will support principal investigators (PIs) in protocol development preparation and...

Position : Coord 3 Regulatory Affairs - Exp in Medical Device Indutry (Req Min 5-7 Yrs Exp)Location : Irvine CADuration : 12 MonthsTotal Hours/week : 40.001st ShiftClient : Medical Devices CompanyLevel of Experience : Senior LevelEmployment Type : Contract on W2 (Need US Citizens or GC Holders or GC...

Position : Coord 3 Regulatory Affairs Location : Irvine CADuration : 12 MonthsTotal Hours/week : 40.001st ShiftClient : Medical Devices CompanyLevel of Experience : Senior LevelEmployment Type : Contract on W2 (Need US Citizens or GC Holders or GC EAD or OPT or EAD or CPTJOB DESCRIPTIONKey Responsib...

About Acadia PharmaceuticalsAcadia is committed to turning scientific promise into meaningful innovation that makes the difference for underserved neurological and rare disease communities around the world. Our commercial portfolio includes the first and only FDA-approved treatments for Parkinsons d...

About Acadia PharmaceuticalsAcadia is committed to turning scientific promise into meaningful innovation that makes the difference for underserved neurological and rare disease communities around the world. Our commercial portfolio includes the first and only FDA-approved treatments for Parkinsons d...

Performing critical work that impacts our industry and our worlds health while problem solving and innovating in the field that is what we get to do every day at KCAS Bio. If that gets you excited too then maybe working at KCAS Bio is for you.When you work as an Analyst II in the Pharmaceutical Liq...

We begin with dreams. Dreams drive our motivation. Dreams are our future. The worlds dreams peoples dreams our dreams. Our passion creates ideas that make dreams come alive. Technology and products that were only dreams become reality.All for dreams. Dreams challenge and the Nidec-Group will continu...

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...