Global Regulatory Jobs in Waltham, MA

Director Clinical PharmacometricsXilio Therapeutics is a clinical-stage biotechnology company discovering and developing tumor-activated immuno-oncology (I-O) therapies with the goal of significantly improving outcomes for people living with cancer without the systemic side effects of current I-O tr...

Role SummaryWe are seeking a highly organized and proactive Clinical Operations professional to support the successful execution of our clinical this key role you will partner closely with the Clinical Operations Study Lead to manage critical components of study deliveryensuring timelines quality s...

We are seeking a dynamic and strategic Associate Director Regulatory Affairs to join our Regulatory Affairs team. The Associate Director of Regulatory Affairs leads the development and execution of global regulatory strategies to support the approval and lifecycle management of pharmaceutical produc...

Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH) a serious liver disease that can progress to cirrhosis liver failure need for liver transplantation and premature mortality. Every member of our Madrigal team...

Purpose:This position participates in global regulatory dossier preparation for AbbVies Biologics portfolio activities by gathering information from internal and external partners and authoring elements of global dossiers. The role prepares sections of regulatory submission documents of high scienti...

Work ScheduleStandard (Mon-Fri)Environmental ConditionsOfficeJob DescriptionUncover a remarkable opportunity at Thermo Fisher Scientific Inc. to push global advancements in health cleanliness and safety as a Sr. IT Program Manager in Waltham. Become a part of our elite team guiding ambitious IT proj...

CSLs R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration were building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing t...

Role SummaryWe are seeking a driven and strategic Medical Director Clinical Development to lead clinical development efforts across one or more early- or late-stage programs. This pivotal role offers the opportunity to shape clinical strategy serve as medical monitor and collaborate cross-functional...

Whats In It for You:This is an exciting leadership opportunity for a person with passion and talent. The company believes that medical writing is a science that continuously evolves with new regulations and technologies.  The role provides the ability to influence company leaders and work on excitin...

Advance your career as Director CMC Product Development where youll oversee the CMC aspects of drug and combination product development across programs align strategy with clinical and regulatory goals and lead a global cross-functional team. Collaborate with key partners communicate critical update...

Job DescriptionCSL is transforming its R&D organization to accelerate innovation and create greater impact for patients. With a streamlined project-led structure and a focus on collaboration were building a future-ready team that excels in dynamic biotech ecosystems. Joining CSL now means being part...

Job DescriptionCSL is transforming its R&D organization to accelerate innovation and create greater impact for patients. With a streamlined project-led structure and a focus on collaboration were building a future-ready team that excels in dynamic biotech ecosystems. Joining CSL now means being part...

DescriptionArdelyx is a publicly traded commercial biopharmaceutical company founded with a mission to discover develop and commercialize innovative first-in-class medicines that meet significant unmet medical needs. Ardelyx has two commercial products approved in the United States IBSRELA (tenapano...