Senior Director Regulatory Affairs Strategy

About the Role:Takeda Pharmaceutical is seeking a highly skilled Senior Regulatory Affairs Director to lead the development and execution of global CMC regulatory strategies for assigned products. As a key member of the Global Regulatory Affairs CMC team, you will be responsible for ensuring regulatory compliance with global health authorities and developing...

Job Title: Manager, Global Regulatory Affairs CMC Submissions ManagementTakeda Development Center Americas, Inc. is seeking a highly skilled professional to establish global submission activities and timelines in partnership with global and cross-functional stakeholders in Pharmaceutical Science, GMS, and Biologics.Key Responsibilities:Develop and implement...

Job SummaryTakeda Development Center Americas, Inc. is seeking a highly skilled Manager, Global Regulatory Affairs CMC Submissions Management to join our team in Lexington, MA. As a key member of our regulatory affairs team, you will be responsible for ensuring compliance with global CMC regulations for advanced therapies and biological compounds.Key...

Job SummaryTakeda Development Center Americas, Inc. is seeking a highly skilled Manager, Global Regulatory Affairs CMC Submissions Management to join our team in Lexington, MA. As a key member of our regulatory affairs team, you will be responsible for ensuring compliance with global CMC regulations for advanced therapies and biological compounds.Key...

Job DescriptionTakeda Development Center Americas, Inc.is seeking a Manager, Global Regulatory Affairs CMC Submissions Management in Lexington, MA with the following requirements:Key Responsibilities:Develop and maintain strong working relationships with the regulatory CMC team and cross-functional teams, participate on and/or lead multifunctional teams,...

About the RoleTakeda is seeking a highly skilled Senior Manager, US Medical Ad/Promo Regulatory Review to join our team. As a key member of our Regulatory Affairs department, you will be responsible for ensuring compliance with FDA regulations and guidelines for the promotion of prescription drug and biologic products.Key ResponsibilitiesCollaborate with...

At Takeda Pharmaceutical, we are seeking a highly skilled Manager, Global Regulatory Affairs CMC Submissions Management to join our team in Lexington, MA.Key Responsibilities:Develop and maintain strong working relationships with the regulatory CMC team and cross-functional teams.Participate on and/or lead multifunctional teams to handle and prioritize...

About the RoleWe are seeking a highly skilled Senior Manager, US Medical Ad/Promo Regulatory Review to join our team at Takeda. As an internal expert on FDA regulations, guidance, and enforcement trends governing the promotion of prescription drug and biologic products, you will provide regulatory strategic oversight for at least one complex product or...

Job SummaryKiniksa Pharmaceuticals is seeking a highly skilled and experienced Director/Senior Director, Program and Alliance Management to lead and champion global program teams and applicable subteams for advancing Kiniksa's product candidates within our growing development portfolio.Key ResponsibilitiesEstablish, lead, and champion global program teams...

Job Title: Director, Medical Communications and Scientific Training – Immunology/DermatologyAt Takeda, we are seeking a highly skilled and experienced Director, Medical Communications and Scientific Training to join our team in Lexington, MA. As a key member of our Medical Affairs department, you will be responsible for leading and developing innovative...

Job SummaryWe are seeking an experienced Associate Director to lead our Analytical Development team in Bioanalytics Late Stage. The successful candidate will have a strong background in analytical development, with expertise in scientific methods and technology implementation. They will be responsible for driving team objectives, managing team performance,...

About the Role:We are seeking a highly skilled Senior Reliability Engineer to join our team at Takeda Pharmaceutical. As a key member of our Reliability Engineering group, you will play a critical role in improving the reliability of our equipment, utilities, and critical systems.As a Senior Reliability Engineer, you will lead reliability-driven actions that...

Job SummaryThe Senior Clinical Research Coordinator will oversee a portfolio of clinical research projects in the Lurie Center for Autism Division, working independently with minimal guidance from the PI. This role is responsible for leading the development, implementation, and analysis of clinical research projects, ensuring adherence to quality, safety,...

Senior Engineering Manager Job DescriptionJohnson and Johnson is seeking a highly skilled Senior Engineering Manager to join our team. As a key member of our CMC team, you will be responsible for representing the device function on development programs and working closely with Quality, Regulatory, Commercial, and other stakeholders to ensure the successful...

About the Role:We are seeking a highly skilled Senior Reliability Engineer to join our team at Takeda Pharmaceutical. As a key member of our Reliability Engineering group, you will play a critical role in improving the reliability of our equipment, utilities, and critical systems.Key Responsibilities:Develop and Implement Reliability Strategies: Develop and...

Job Title: Clinical Development DirectorThe Clinical Development Director will be a key member of our clinical development team, responsible for planning, conducting, analyzing, and reporting clinical studies. This role requires strong leadership and collaboration skills to ensure the timely execution of the clinical development plan.Key...

About the Role:Takeda Pharmaceutical is seeking a highly skilled User Experience and User Interface Designer to join our Product Design team. As a key member of our team, you will be responsible for designing user-centric solutions for interface elements, including devices, packaging, digital ancillaries, and instructional materials.Key Responsibilities:User...

About the RoleThe Director Clinical Scientist is a key member of the clinical development team responsible for planning, conducting, analyzing, and reporting clinical studies. This position requires working independently across functional teams and leading/managing others to ensure timely execution of the clinical development plan.Key ResponsibilitiesDevelop...

Takeda Development Center Americas, Inc. is seeking a Data Systems QA and Compliance Leader to serve as a subject matter expert in computer system validation requirements for systems used by Takeda's global R&D organization. The ideal candidate will have a strong understanding of regulatory requirements and industry standards. Key responsibilities...

About the RoleTakeda Pharmaceutical is seeking a highly skilled User Experience and User Interface Designer to join our Product Design team. As a key member of our team, you will be responsible for designing user-centric solutions for interface elements, including devices, packaging, digital ancillaries, and instructional materials.Key...