Senior Manager, Regulatory Compliance, R&D Quality

Senior Manager, R&D Training LeadProclinical Staffing is seeking a Senior Manager, R&D Training Lead to co-manage a global GxP Training Program at a well-known biotech company. This hybrid role involves both on-site work and remote work.Key Responsibilities:Maintain a compliant GxP Training Program in line with US and international guidelines.Manage and...

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...

Regulatory Compliance SpecialistModerna is seeking a highly skilled Regulatory Compliance Specialist to join our R&D Quality team. As a key member of our team, you will be responsible for ensuring compliance with Health Authority Regulations and guidelines.Key Responsibilities:Plan and coordinate GCP, GVP, GLP, GCLP regulatory authority inspectionsBuild and...

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...

Job Title: Senior Regulatory Affairs Specialist, OperationsAbout the Role:The Senior Regulatory Affairs Specialist will work within our Sleep & Respiratory Care business group (SRC) on home and hospital respiratory care products.This role will primarily support Software as a Medical Device (SaMD) and may include support for ventilators, oxygenators, 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...

Clinical Compliance Leadership PositionThe Senior Manager, Clinical Compliance will provide critical support and guidance to clinical trial teams on Clinical Compliance requirements and activities.This role requires a collaborative partnership with cross-functional team members across the organization to ensure all trials are conducted in compliance with...

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 DescriptionAt Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on three therapeutic areas and other targeted investments, we push the boundaries of what is possible to bring life-changing therapies to patients worldwide.Key...

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...

Job SummaryWe are seeking a highly skilled People Data and Analytics Lead to join our Research and Development (R&D) team. As a key member of the R&D HR team, you will be responsible for implementing key projects to deliver people data and analytics solutions that support our global R&D organization.About the RoleThis is an outstanding opportunity for a...

Job SummaryAs a Regulatory Affairs Director at Ipsen Pharma, you will be responsible for developing and implementing regulatory strategies for assigned programs and products. You will provide regulatory expertise to R&D, Franchise, and Commercial Operations, and act as the interface between these teams and global regulatory authorities. Your goal will be to...

Job DetailsThe Role: The Senior Manager, Clinical Compliance will provide support and guidance to clinical trial teams on Clinical Compliance requirements and activities. The candidate will work to support trial teams across different stages of development and multiple therapeutic areas. The successful candidate will be skilled at both understanding and...

Job SummaryWe are seeking a highly skilled Associate Director, PV Quality to join our team. The successful candidate will provide quality oversight of, and support and guidance to the Moderna pharmacovigilance system and pharmacovigilance activities conducted by Moderna and its service providers.The Associate Director, PV Quality will lead the development of...

Job SummaryWe are seeking a highly skilled and experienced Associate Director, PV Quality to join our team. The successful candidate will be responsible for providing quality oversight of, and support and guidance to the Moderna pharmacovigilance system and pharmacovigilance activities conducted by Moderna and its service providers.The Associate Director, PV...

Job Summary: We are seeking a highly skilled Senior Quality Assurance Manager to join our team at The Fountain Group. The ideal candidate will have a strong background in pharmaceutical quality assurance and regulatory compliance.Key Responsibilities:Review and approve regulated study reports from third-party vendorsSupport M&A integration activities and...

Job OverviewNanobiosym, a pioneering nanotechnology company in Cambridge, MA, is seeking a highly skilled Senior Scientist to lead the development of innovative molecular diagnostic assays. As a key member of our team, you will be responsible for designing and implementing assay performance specifications, ensuring compliance with regulatory requirements,...

Job SummaryWe are seeking an experienced Associate Director, PV Quality to provide quality oversight of, and support and guidance to the Moderna pharmacovigilance system and pharmacovigilance activities conducted by Moderna and its service providers. The successful candidate will provide compliance support to the Moderna PV organization, establish and...

Job DescriptionLanceSoft is seeking a highly skilled Contract Management Lead to join our team. The successful candidate will be responsible for managing and executing contracts, ensuring compliance with company requirements and policies.Key Responsibilities:Manage and execute contracts, including Master Service Agreements (MSAs), Statement of Work (SOW),...

At Bayer, we're driven to solve the world's toughest challenges and strive for a world where 'Health for all Hunger for none' is no longer a dream, but a real possibility.We're doing it with energy, curiosity, and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities, and redefining...