Regulatory Documents Jobs in Waltham, MA

Job Title: Director Project Toxicologist BioPharma Safety in Clinical Pharmacology & Safety Sciences (CPSS)Location: Gaithersburg (MD) Waltham (MA) Boston (MA) Gothenburg (SE) Cambridge (UK).At AstraZeneca it is our bold ambition to achieve disease modification clinical remission and cure toimpactth...

Role Summary:The Director Clinical Operations is responsible for ensuring that clinical stage programs achieve strategic and operational objectives within established timelines budget and quality standards. This role provides leadership to the Clinical Operations team contributes to the development...

CSL Behring is a global biotechnology leader guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives.With operations in 35 nations and 30000 empl...

At 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 transform peoples li...

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...

Xilio 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 treatments. The company is using it...

CSL Behring is a global biotechnology leader guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives.With operations in 35 nations and 30000 empl...

Senior Manager Regulatory Project Management and OperationsThe Senior Manager of Regulatory Project Management and Operations is responsible for leading the planning coordination and delivery of high-quality regulatory submissions to global health authorities. This role ensures submission readiness...

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...

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...

The Precision Medicine Immunology group is hiring an experienced translational and biomarker scientist with expertise in immunology who will be responsible for the development planning execution and interpretation of translational precision medicine activities in support of the immunology clinical d...

Vice President Chemical Manufacturing and Control (VP-CMC)Skyhawk Therapeutics a clinical-stage biotechnology company is seeking a Vice President of Chemical Manufacturing and Control (CMC) to execute our rapidly expanding development pipeline of small molecule therapeutics. This role will be based...

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...

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...

Role Summary: The Senior Director Pharmacovigilance Sciences Lead plays a critical role by leading the PV Sciences team and providing strategic oversight for safety data analyses for investigational and marketed products across the portfolio.The Senior Director Pharmacovigilance Sciences Lead is exp...

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...

At AstraZeneca it is our bold ambition to achieve disease modification clinical remission and cure to impact the lives of millions of people worldwide suffering from cardiovascular renal metabolic and respiratory diseases. We are now expanding our diverse pipeline to secure leadership in numerous Bi...