Regulatory Affairs Manager

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 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 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,...

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...

Job Title: Senior Director, Regulatory Affairs StrategyAt Kiniksa Pharmaceuticals, we are seeking a highly experienced Senior Director to lead our Regulatory Affairs Strategy team. As a key member of our organization, you will be responsible for developing and implementing global regulatory strategies to ensure the successful registration and life-cycle...

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...

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...

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...

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...

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...

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...

About the Role:Takeda is a world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. We are seeking a User Experience and User Interface Designer to join our team, where you will be responsible for designing user-centric solutions for interface elements, including devices, packaging, digital ancillaries, and...

Job Title: Manager, Statistical ProgrammerWe are seeking a highly skilled Manager, Statistical Programmer to join our team at Takeda Development Center Americas, Inc. in Lexington, MA.Job Summary:The Manager, Statistical Programmer will be responsible for leading and organizing study-level programming and oversight activities for analysis of clinical trial...

Job Title: Quality Control ManagerWe are seeking a highly skilled Quality Control Manager to join our team at Genezen. As a Quality Control Manager, you will be responsible for overseeing the day-to-day operations of the QC Bioassay and Virology Testing group within the QC Operations department.Key Responsibilities:Maintain a safe, efficient, functional, and...

Job Title: Registered Nurse (RN) Clinical Case Manager- Home HealthJob Summary:Interim HealthCare is seeking a highly skilled and experienced Registered Nurse (RN) Clinical Case Manager to join our team. As a Clinical Case Manager, you will play a key role in the quality, compliance, and satisfaction of the services we provide.Key Responsibilities:Oversee...

New Lexington Healthcare & Rehabilitation Center LLC is seeking a skilled Licensed Practical Nurse or Registered Nurse to fill a Unit Manager role. This position is ideal for a Registered Nurse or Licensed Practical Nurse with experience in IV Certification and wound care. The Unit Manager will be responsible for leading a team of healthcare professionals...

Job DescriptionTakeda Development Center Americas, Inc. is seeking a highly skilled Statistical Programming Manager to join our team in Lexington, MA.Key Responsibilities:Lead and organize study-level programming and oversight activities for analysis of clinical trial data, ensuring quality and timeliness.Prepare deliverables for regulatory submission to...

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...

Job SummaryKiniksa Pharmaceuticals is a commercial stage, publicly traded biopharmaceutical company with a mission to help patients suffering from debilitating diseases with significant unmet medical need. We are seeking a highly skilled Senior Manager, Upstream Process Development and Manufacture to join our team.Key ResponsibilitiesManage and support tech...

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...