Senior Manager, Regulatory Compliance, R&D Quality

About the RoleWe are seeking a highly skilled Senior Manager, Inspection Management, R&D Quality to join our team at Moderna. As a key member of our R&D Quality team, you will play a critical role in ensuring compliance with Health Authority Regulations and supporting inspections across R&D.Key ResponsibilitiesDevelop and maintain strong relationships with...

About the RoleWe are seeking a highly skilled Senior Manager, Inspection Management, R&D Quality to join our team at Moderna. In this role, you will be responsible for leading the planning, coordination, and execution of regulatory health authority inspections across R&D. You will work closely with cross-functional teams to ensure compliance with health...

Job Title: Senior Manager, R&D TrainingProclinical Staffing is seeking a Senior Manager, R&D Training to co-manage a global GxP Training Program at a well-known biotech company. This hybrid role involves both on-site work in Cambridge, MA, and remote work.Key Responsibilities:Maintain a compliant GxP Training Program in line with US and International...

Senior Manager, R&D Training (GxP) Job DescriptionProclinical Staffing is seeking a highly skilled Senior Manager, R&D Training (GxP) to co-manage a global GxP Training Program at a well-known biotech company. This hybrid role involves both on-site work in Cambridge, MA, and remote work.Key Responsibilities:Maintain a compliant GxP Training Program in line...

About USDM Life SciencesWe are a premier consulting company with 20+ years of experience assisting heavily regulated biotech, medical device, and pharmaceutical companies with their GxP compliance needs.Job Title: R&D Procurement ManagerAs a Quality Consultant, you will be responsible for ensuring the quality of our clients' products and services. Your...

Job SummaryWe are seeking a highly experienced and skilled Head of R&D Legal, R&D Transactions and Technical Research to lead the legal support of complex R&D collaborations, partnerships, contracts, divestments, alliance management, and the legal integration of acquired companies with pre-clinical and clinical stage assets.Key Responsibilities:Provide legal...

R&D Procurement Manager Job DescriptionJob Title: R&D Procurement ManagerJob Function: Quality ConsultantLocation: Cambridge, MAUSDM Life Sciences is a premier consulting company with 20+ years of experience assisting heavily regulated biotech, medical device, and pharmaceutical companies with their GxP compliance needs. We are seeking a highly skilled R&D...

Job DescriptionWe are seeking a highly skilled and experienced Manager, R&D Finance to join our team in Cambridge, MA. As a key member of our finance team, you will be responsible for providing financial planning, analysis, and reporting support to our development functions.Key ResponsibilitiesDevelop and manage financial plans, forecasts, and budgets for...

About USDM Life SciencesUSDM Life Sciences is a premier consulting company with 20+ years of experience assisting heavily regulated biotech, medical device, and pharmaceutical companies with their GxP compliance needs.Job Title: R&D Procurement ManagerJob Function: Quality ConsultantLocation: Cambridge, MA - HybridWe are seeking a highly skilled R&D...

Job Summary We are seeking a highly skilled Senior Counsel, R&D Business Development to join our team at Takeda Pharmaceutical Company Limited. As a key member of our R&D Legal function, you will play a critical role in supporting senior attorneys on business development transactions and leading selected licensing and other business development transactions...

About the RoleAt Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. We are seeking a highly skilled and experienced Regulatory Affairs professional to join our team as an Associate Director, Global Reg Affairs Device, PDT in our Global Regulatory Affairs CMC & Device...

Job Title: Senior Principal Combination Product Quality EngineerBiogen is seeking a seasoned Senior Principal Combination Product Quality Engineer to serve as an Associate Director within our Quality, Combination Products, and Devices team.Key Responsibilities:Provide comprehensive quality oversight for the lifecycle management of combination products.Lead...

About USDM Life SciencesUSDM Life Sciences is a leading consulting company with extensive experience in assisting heavily regulated biotech, medical device, and pharmaceutical companies with their GxP compliance.Job Title: R&D Procurement ManagerAs a Quality Consultant, you will be responsible for ensuring the procurement of high-quality materials and...

About the RoleAs a Data Governance and Management Expert, you will lead the implementation and management of a data and data systems governance strategy according to R&D and enterprise stakeholders. You will redefine raw data into relevant insights, helping the organization make informed decisions, optimize performance, and achieve overall data strategy...

Job DescriptionAs a Senior Counsel, R&D Business Development, you will play a critical role in supporting the R&D Legal function by collaborating with senior attorneys on business development transactions. Your expertise will be essential in leading selected licensing and other business development transactions for Takeda's R&D function.Key...

Job SummaryWe are seeking a highly skilled Senior Counsel to join our R&D Business Development team. As a key member of our team, you will be responsible for supporting senior attorneys on business development transactions, leading selected licensing and other business development transactions, and developing and applying analytical skills to assist with the...

Job SummaryThe Director of Regulatory Affairs will be responsible for developing and implementing regulatory strategies for assigned programs and products. This includes providing regulatory expertise to R&D, Franchise, and Commercial Operations, as well as serving as the interface between these teams and the Global Regulatory Affairs (GRA) organization.Main...

Job SummaryTakeda is seeking a highly skilled and experienced Senior Director and Regulatory Platform Lead for Device and Drug-Device Combinations to join our team. As a key member of our regulatory affairs department, you will be responsible for leading the development and implementation of innovative regulatory strategies for device and drug-device...

Job Title: Senior Manager, Clinical Operations Quality ComplianceBicycle Therapeutics is a clinical-stage pharmaceutical company developing innovative medicines for underserved diseases. We are seeking a knowledgeable and resourceful Senior Manager, Clinical Operations Quality Compliance to collaborate with Clinical Operations, Clinical Quality, and other...

Job Title: Senior Principal Supplier Quality SpecialistAkebia Therapeutics is seeking a highly skilled and experienced Senior Principal Supplier Quality Specialist to join our Quality Assurance team. This role will be responsible for managing and overseeing Akebia's suppliers and contract manufacturing organizations (CMOs) to ensure compliance with industry...