- BeiGene (San Mateo, CA)
- **General Description:** + The Manager , Regulatory Affairs CMC , is responsible for developing and implementing global regulatory CMC strategies to ... and in coordination with key internal stakeholders. This position will manage regulatory CMC aspects of compounds (large molecules) through all phases… more
- Gilead Sciences, Inc. (Foster City, CA)
- …worldwide, with headquarters in Foster City, California **About the role:** The CMC Regulatory Affairs Sr . Manager at Gilead is responsible for providing ... strategic direction, operational support, and technical expertise for CMC regulatory activities and related regulatory initiatives. **Responsibilities:** +… more
- BeiGene (Emeryville, CA)
- …assigned projects. The individual will provide support to cross-functional teams on CMC regulatory strategies and process optimizations on relevant topics. ... **the** **job:** . Lead, develop and implement small molecule CMC regulatory strategies as well as authoring...throughout product life cycle. Escalate the critical issues to senior management timely. . Lead or contribute to development… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …this role, a typical day might include the following:** + Responsible for CMC /CP product development activities to lead the regulatory standpoint during early ... for program-specific discussions, connect the dots across IOPS, proactively identify CMC /CP regulatory issues and develop appropriate strategies to mitigate… more
- AbbVie (North Chicago, IL)
- …YouTube and LinkedIn. Job Description The Senior Manager Regulatory Affairs, Chemistry, Manufacturing and Controls ( CMC ) works with internal and ... external partners to deliver products to patients. Prepares CMC regulatory strategies that enable first pass approvals. Develops and manages content strategy for… more
- BeiGene (Hopewell, NJ)
- …position plays a PM and CMC leading role in Technology Transfer and CMC regulatory filings by setting clear objectives and empowering their team. This ... position involves close collaboration within regulatory CMC , MS&T, Process Development, Manufacturing, Quality Control, Quality Assurance, and Regulatory … more
- BeiGene (San Mateo, CA)
- **General Description:** Sr . Manager /Associate Director, Supply Chain CMO Management & PM will own and enable the communication, coordinate tasks between the ... with Contract Manufacturers (CMO) + In partnership with Quality, CMC , Procurement, ensures that innovation, manufacturing performance, cost objectives and… more
- Taiho Oncology (Princeton, NJ)
- …procurement operations and external supplier development and management. Position Summary: Senior Manager , Outsourcing and Vendor Management, supports and ... Sr . Manager , Outsourcing & Vendor Management...negotiation, and project award. + Ensures compliance with all regulatory and reporting requirements related to Supplier Diversity and… more
- Amazon (North Reading, MA)
- …support a well-established yet rapidly expanding team. This position reports directly to the Sr Manager of Regulatory Compliance. Key job responsibilities * ... Description We are seeking a Senior Manager for our functional safety...Engineering, Technical Program Management, Advanced Quality Planning, Safety & Regulatory Compliance, Reliability, Strategic Sourcing and Design for Assembly.… more
- Integra LifeSciences (Plainsboro, NJ)
- …are challenging what's possible and making headway to help improve outcomes. This ** Senior Manager , Quality Operations** will manage and provide oversight on ... understand quality system requirements and how they impact product quality and regulatory compliance. + Works with Senior Management to achieve alignment… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The ** Sr Manager , Clinical Drug Supply & Logistics** is responsible for providing oversight of individual or multiple clinical programs, forecasting ... monitors, as well as staff from quality, clinical compliance, regulatory , formulations, and IOPS ( CMC , external manufacturing,...include the following:** + Serves as lead drug supply manager of a program and/or individual studies for the… more
- Takeda Pharmaceuticals (Boston, MA)
- …development functions. + Prepare and coordinate completion of technology transfer documentation, CMC sections of regulatory documents, or validation plans and ... and transfer; + Ability to design and direct analytical strategy to meet CMC project objectives. + Experience in preparing regulatory documentation. **More about… more
- Gilead Sciences, Inc. (Foster City, CA)
- …delivery of safe life-changing therapies. **Job Summary:** Gilead Sciences seeks a Sr . Manager , Quality Assurance, in the Pharmaceutical Development and ... Manufacturing (PDM) organization. The Sr . Manager provides quality and compliance activities...ensures visibility and communication of key project timelines and CMC milestones + Acts in a project manager… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- Regeneron is seeking a Manager to join the Regulatory Intelligence Group! **In this role, a typical day might include:** The Regulatory Intelligence ... from assigned departments or functions within the organization's GxP framework. The Regulatory Intelligence Manager will also facilitate processes to hold… more
- Bristol Myers Squibb (Summit, NJ)
- …a member of a cross functional team responsible for drug product related CMC strategy development. **Key Responsibilities** The Senior Principal Scientist will ... and support the generation of appropriate responses to questions from regulatory authorities. **Key Responsibilities** The Senior Principal Scientist will… more
- Intra-Cellular Therapies, Inc (Bedminster, NJ)
- …the CMC (Chemistry, Manufacturing and Controls) team of ITCI, **the** ** Senior Manager , Formulation Development** will be responsible for leading drug ... the Manufacturing and Supply Chain group of the ITCI CMC team. Responsibilities: + Lead and support activities for...veteran status, disability or any other legally protected status. Senior Manager , Formulation Development: Base Salary Range… more
- BeiGene (San Mateo, CA)
- …and information, by collaborating with cross functional teams (RA, IT, QA etc.). The Manager / Sr . Manager Data Management and Governance is responsible for ... oversight of central regulatory data entry into RIM, compliance with internal data...regulatory technology and submissions (eg, eCTD, IDMP, SPOR/DADI, PQ- CMC , SPL) and coordinate impact assessment on systems and… more
- Ascendis Pharma (Palo Alto, CA)
- …information to project teams. + Works independently with directional support from a Senior Regulatory Affairs professional. Requirements + BS/BA Degree in a ... of the business, from drug development to marketing. The Manager , Regulatory Affairs will be responsible for...Affairs. Key Responsibilities + Responsible for strategic and operational regulatory input and support for cross functional ( CMC… more
- Inovio Pharmaceuticals (San Diego, CA)
- …own disease-fighting tools. For more information, visit www.inovio.com . Job summary The Senior Manager , Drug CMO, Quality Assurance is responsible for managing ... of products and their manufacture at these locations. The Senior Manager will perform quality review of...to ensure alignment and timelines are met. + Review CMC sections for regulatory submissions. + Routinely… more
- Novo Nordisk (Watertown, MA)
- …+ Identify key stake holders and work collaboratively with cross-functional CMC , commercial, quality, regulatory , project management, legal, sourcing, supply ... team based in Watertown, MA and report to the manager of the drug product outsourcing group. The team...team player. + Experienced in writing, reviewing, and approving CMC sections of regulatory filings from early-stage… more