Regulatory Submissions Jobs in USA

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...

We anticipate the application window for this opening will close on - 1 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 co...

Job DescriptionThe Executive Director Chemistry Manufacturing Control for Biologics (Biologics-CMC) is accountable for managing a team of CMC professionals and ensuring rigor in CMC regulatory strategy as well as delivery of high quality CMC submissions for late phase new modality biologics products...

We anticipate the application window for this opening will close on - 29 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...

Who We AreAt Corebridge Financial we believe action is everything. Thats why every day we partner with financial professionals and institutions to make it possible for more people to take action in their financial lives for today and tomorrow.We align to a set of Values that are the core pillars tha...

PurposeServes as a process engineering subject matter expert responsible for the development optimization and technology transfer of oral solid dosage form (OSD) drug products within a pharmaceutical manufacturing environment. This position independently investigates and resolves complex manufacturi...

Location: Paramus NJ Work Arrangement: Onsite Job Type: Contract A growing pharmaceutical organization is seeking an experienced Biostatistics leader to support clinical development programs from protocol design through final study reporting regulatory submissions and post-study analysis. This role...

About the Role: The Senior Scientist Process Analytics Drug Substance is a key technical leadership role focused on analytical development process analytical technology and control strategy design within a clinical-stage biopharmaceutical environment. This position supports drug substance and drug p...

About the Role: The CMC Director or Senior Director Regulatory Affairs is a strategic leadership role responsible for global Chemistry Manufacturing and Controls regulatory strategy and execution across the product lifecycle. This position oversees CMC submissions regulatory intelligence and health...

Lantheus (NASDAQ: LNTH)is the leading radiopharmaceutical-focused company delivering life-changing science to enable clinicians to Find Fight and Follow disease to deliver better patient outcomes. Headquartered in Massachusetts with offices in New Jersey Canada Germany Sweden Switzerland and United...

Senior Statistician II - BiostatisticsLocation: Boston MAThe Senior Statistician II has sufficient experience working as a statistician in the pharmaceutical industry to be on activities relating to design delivery and interpretation regulatory submissions and/or commercialization. This individual i...

OverviewThis is an exciting opportunity to join LeMaitre Vasculars Regulatory Affairs team. We are seeking someone looking for a role where they can have a real impact while building their capabilities and growing their career.In this role the candidate will be responsible for developing and impleme...

Safetec of America is seeking a regulatory professional to support and ensure compliance across all product lines and operations. This role is responsible for managing regulatory submissions product registrations labeling approvals and site licenses while staying current on FDA EPA and global regula...

Make your mark for patientsWe are looking for a Senior Project Lead Programmer who is strategic collaborative and innovative to join us in our Biometrics and Data Science team based in our Raleigh NC office in the United States.About the roleIn this role you will serve as the senior programming lead...

OverviewThe Director Quality Assurance provides strategic and operational leadership for Quality Assurance across Qpexs multi-therapeutic multinational Phase 13 infectious disease development programs. This role is responsible for designing implementing and overseeing robust global quality systems t...

OverviewThe Director Quality Assurance provides strategic and operational leadership for Quality Assurance across Qpexs multi-therapeutic multinational Phase 13 infectious disease development programs. This role is responsible for designing implementing and overseeing robust global quality systems t...

Posting SummaryThe Department of Obstetrics Gynecology and Reproductive Sciences is looking for a clinical research coordinator to administer and coordinate research studies and provide research support as a member of a research team. This individual will recruit potential research subjects to clini...

Why Sarepta Why Now The promise of genetic medicine has arrived and Sarepta is at the forefront. We hold a leadership position in Duchenne muscular dystrophy (Duchenne) and are building a robust portfolio of programs across muscle central nervous system and cardiac 2023 we launched our fourth thera...

Business IntroductionAt GSK we have bold ambitions for patients aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines combining our understanding of the immune system with cutting-edge technology to...

Company:At Annexon Biosciences we are a biopharmaceutical company advancing a late-stage clinical platform of novel therapies for people living with devastating classical complement-mediated neuroinflammatory diseases of the body brain and eye. Our novel scientific approach targets upstream C1q to b...