Regulatory Affairs Expert

Job SummaryWe are seeking a highly skilled Biologics Regulatory Affairs Director to join our team at Takeda. As a key member of our GRA CMC team, you will be responsible for developing and executing regulatory strategies for assigned products.Responsibilities:Develops, executes, and oversees regulatory submissions preparation per the GRA CMC Product Team CMC...

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.

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 RoleWe are seeking an experienced Global Regulatory Affairs Director to join our team in Cambridge, MA. In this role, you will play a key part in developing and executing regulatory strategies for biologics development.Job DescriptionAs a Global Regulatory Affairs Director, you will be responsible for leading the execution of regulatory CMC...

About TakedaTakeda is a patient-focused company that drives innovation in specialty pharmaceuticals and patient support programs.We are certified as a Global Top Employer and strive for excellence in everything we do, fostering an inclusive and collaborative work environment where our teams are united by an unwavering commitment to deliver Better Health and...

Clinical Development Scientist Job Summary:We are seeking a highly motivated Clinical Development Scientist to join our team at 3500 Square LLC. The successful candidate will be responsible for leading clinical development initiatives, developing clinical development plans, and collaborating with internal and external stakeholders.Responsibilities:Develop...

Job Summary:The Cambridge Health Alliance seeks an accomplished Accreditation and Regulatory Compliance Expert to lead efforts in ensuring continual organizational compliance and readiness with clinical quality and patient safety standards and regulations. This role involves developing and maintaining a continuous readiness program across the institution for...

OverviewBicycle Therapeutics is a pioneering pharmaceutical company dedicated to developing novel, life-changing medicines. As a key member of our team, you will play a crucial role in shaping the future of medical affairs strategy.About the RoleThe Associate Director/Director, Medical Affairs Strategy will be responsible for leading scientific and medical...

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.

key-responsibilities: Develops project and/or significant technical strategy and leverages technical skill(s) as a resource/expert within the department.Collaborates closely with cross-functional teams, including process chemistry, analytical development, drug product development, manufacturing, quality assurance, and regulatory affairs, to develop and...

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...

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 Scholar Rock:Scholar Rock is a biopharmaceutical company that discovers, develops, and delivers life-changing therapies for people with serious diseases.With a focus on advancing innovative treatments where protein growth factors are fundamental, the company has created a pipeline with the potential to advance the standard of care for various...

About the PositionWe are seeking an Oncology Medical Science Expert to join our team at Lifelancer. As a key member of our medical affairs team, you will be responsible for supporting the development and life-cycle management of our oncology medicines.In this role, you will engage with key opinion leaders, collect medical insights and intelligence, and...

Join Alnylam Pharmaceuticals as a Quality Control Lead and play a key role in ensuring the quality and integrity of our products.The estimated salary for this position is $160,000 - $220,000 per year, depending on experience.About the Role:Lead quality control operations, including method development and implementationCollaborate with cross-functional teams...

About the PositionWe are seeking a highly skilled and organized individual to fill the role of Search Coordinator Expert at Harvard University. In this position, you will provide administrative support for the Office of Academic Affairs, focusing on the faculty review process.Salary: $66,000 - $82,000 per year, depending on experience.Your responsibilities...

About the RoleAs a Clinical Data Management Lead, you will be responsible for leading and contributing to data management activities in support of Alnylam studies across all stages of clinical drug development.ResponsibilitiesLead data management activities as a program-level lead data manager in support of Alnylam clinical studies Lead database build...

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 Title: Molecular Diagnostics ExpertNanobiosym is a leading nanotechnology company based in Cambridge, MA, pioneering novel technologies to address complex diseases. Our team of experts works at the interface of physics, nanotechnology, and biomedicine. As a pioneer in our field, we were awarded the 2013 X-PRIZE for healthcare innovation.We are seeking an...

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...