Global Regulatory Affairs Director | Biologics Development

Key ResponsibilitiesThe Regulatory Affairs Expert will be responsible for ensuring compliance with global regulatory requirements, including GCP, FDA regulations, and EU MDR. The successful candidate will have a deep understanding of regulatory pathways, clinical trial design, and data analysis, as well as excellent communication and project management...

Job OverviewClinical Affairs Consultant - 8 month contract + possible extensions/conversion. Hybrid role, 3X week on-site in Bothell, WA or Cambridge, MA.About the RoleAs a Clinical Affairs Consultant, you will play a key part in generating evidence to support Philips' regulatory clearances, claims, and market access. You will lead the development of...

About the Opportunity: We are seeking a highly experienced Medical Director to lead our Global Medical Affairs efforts for a late-stage clinical investigational compound indicated for SLE. As a key member of our team, you will provide strategic guidance on clinical development, regulatory strategy, and launch planning.Responsibilities:Develop and implement...

About the OpportunityWe are seeking a highly skilled Senior Medical Director to join our team at Biogen, responsible for developing and implementing the Global Medical Strategy for our Lupus asset. This strategic role will require collaboration with cross-functional partners to ensure key medical insights are understood and executed in a prioritized...

Job SummaryThe Director of Medical Affairs is responsible for overseeing the development and execution of medical education plans, collaborating with internal stakeholders to ensure alignment with global business strategies, and contributing to the creation of clinical and scientific data. If you have experience in neuroscience or psychiatry and possess...

About the RoleWe are seeking a seasoned Strategic Regulatory Affairs Leader to drive our regulatory and quality assurance efforts for pharmaceutical products and sleep monitoring devices. This is an exciting opportunity to develop and implement the regulatory affairs strategy that will propel major paradigm shifts in the treatment of sleep apnea.

About the RoleWe are seeking a highly experienced Senior Medical Director to lead our global therapeutic development efforts in nephrology and transplant medicine. As a key member of our clinical development team, you will be responsible for driving strategy and making high-impact decisions that shape the future of our specialty care products.Key...

Job OverviewWe are a publicly traded biotechnology company developing innovative solutions for chronic dermatological diseases.Salary and Benefits$240,000 - $270,000 per year. Competitive salary, annual bonus, equity, ESPP, 401k program, medical/vision/dental benefits, and hybrid schedule.Job DescriptionWe seek a Senior Director of Quality Assurance (GMP) to...

Role Overview:We are seeking a highly experienced Senior Manager/Associate Director, Quality Control to lead our QC activities for antibody and fusion protein products across our pipeline.About the Job:In this role, you will develop strategies and execute QC activities for all pipeline programs. This includes in-process/release/stability testing,...

About Catalytic Data ScienceCatalytic Data Science is a pioneering start-up revolutionizing the life sciences industry by leveraging cutting-edge AI platforms to enhance Regulatory Affairs Intelligence.

About the Opportunity">We are seeking an experienced Senior Director, Global Marketing to lead the successful launch of apitegromab, our phase 3 candidate for the treatment of Spinal Muscular Atrophy (SMA). As a key member of our global marketing team, you will play a critical role in developing and executing marketing strategies to support the launch and...

Opportunity for Career Growth in Arts ManagementWe are seeking a highly motivated and experienced Individual Giving Manager to join our team at Global Arts Live. As a key member of our development department, you will play a critical role in leading impactful projects and contributing to the organization's mission.About UsGlobal Arts Live is a leading force...

Job Description:We are seeking an experienced Clinical Operations Director to lead the management of late-stage clinical trials for our pharmaceutical company. This role will oversee the integration of project team activities, leveraging internal and development partner resources, expertise, and knowledge.About the Role:Provide strategic input and execution...

About the OpportunityWe are seeking a highly skilled Manager of Statistics to join our Pharmaceutical Sciences team in Cambridge, MA.Job SummaryThis role will provide statistical leadership in the design, analysis, and interpretation of CMC study data throughout Pharmaceutical Sciences, promoting innovative design and analysis methodology.Key...

Job OverviewWe are seeking a Senior Manager/Associate Director, Quality Control to join our CMC team at Third Rock Ventures Stealth NewCo. This role will lead and independently perform technical and operational aspects of QC activities for antibody and fusion protein products across the company's pipeline.About the RoleDevelop and execute QC strategies for...

Job Title: Global Clinical Supply Chain DirectorAbout Us: Biogen is a global biotechnology company dedicated to discovering, developing, and delivering innovative therapies for serious diseases. As a member of our team, you will have the opportunity to work on cutting-edge projects that make a meaningful difference in patients' lives.Job Summary: We are...

Job DescriptionWe are seeking a highly skilled Medical/Scientific Director, Medical Affairs to join our team at AbbVie. As a key member of our medical affairs leadership, you will be responsible for providing strategic and operational input into core medical activities, including healthcare professional interactions, clinical data generation, educational...

Job OverviewWe are seeking a highly skilled Global Clinical Operations Director to lead our clinical development planning and strategy. The successful candidate will be responsible for aspects of clinical study planning and execution within pre-specified timelines and budget.About the RoleLead and manage integration of all project team activities, leveraging...

Clinical Development Expert WantedKennedy Bond seeks an accomplished Senior Medical Director to oversee clinical development in oncology. As a vital part of our team, you will collaborate with experts to develop novel treatments and ensure their alignment with regulatory demands. This is a remarkable chance to join a growing company that's breaking ground in...

About UsWe are a privately held company based in Cambridge, MA, working to transform the treatment of sleep apnea. Our lead development program targets the neurologic control of upper airway muscles to maintain an open airway during sleep. We are committed to innovation as well as state-of-the-art advancements in sleep medicine.Job DescriptionThis is a key...