- 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
- Frontier Medicines (Boston, MA)
- Join Frontier Medicines on an exciting journey as our newest Senior Manager /Associate Director in CMC Development, located at either our Boston or South San ... of our team, reporting directly to the Head of CMC , you'll play an integral role in advancing our...thorough understanding of ICH guidelines, GLP/GMP manufacturing, and related regulatory requirements is required + Ability to travel domestically… more
- Memorial Sloan-Kettering Cancer Center (New York, NY)
- …accessible for MSK employees. Job Description We have an exciting opportunity for a Senior CMC Manager in theOffice of Technology Development (OTD).At ... material changes, and leading or coordinating the delivery of CMC data packages to meet the regulatory expectations for new and approved IND. You will: +… more
- Taiho Oncology (Princeton, NJ)
- …team at Taiho Oncology where innovation thrives, and excellence is celebrated. As a Senior Manager in Analytical Development, you'll play a pivotal role in ... Sr . Manager , Analytical Development Princeton, NJ,...to ensure methods are developed and qualified to meet regulatory requirements, interacts with QA/ Regulatory / CMC … 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
- AbbVie (Madison, NJ)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description Senior Manager , Global Regulatory Strategy, US & Canada, ... product(s) with multiple driver indications within a Therapeutic Area and support the Manager , Global Regulatory Lead (GRL), Associate Director, or Director, in… more
- Lauridsen Group Inc. (Ankeny, IA)
- The Senior Manager of Regulatory Affairs plays a crucial role in ensuring Proliant Health & Biologicals (PHB) products comply with local and international ... with regulatory agencies, cross-functional teams, and stakeholders to develop and implement regulatory strategies. The Senior Manager of Regulatory … more
- CSL Behring (King Of Prussia, PA)
- …biotherapies used to treat serious and often rare conditions. Could you be our next Senior Manager of Regional Regulatory Affairs? This position is located ... regional health authorities and collaborating with respective GRA Global Regulatory Leads (GRLs) (Global Product Strategy or CMC... Regulatory Leads (GRLs) (Global Product Strategy or CMC ) and team members to enhance these relationships. +… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …on real-world evidence, and creating hope for all facing illness. The Senior Director, Commercial Regulatory Affairs, is responsible for the development ... marketed products in US and Canada. In addition, the Senior Director, Commercial Regulatory Affairs, in collaboration...Commercial Regulatory Affairs, in collaboration with Head, Regulatory Affairs and CMC -RA, will review and… more
- Ascendis Pharma (Palo Alto, CA)
- …and those of direct reports. + Work is performed under direction of a Senior Regulatory Affairs professional. Requirements + BS/BA Degree in a Scientific ... of the business, from drug development to marketing. The Manager , Regulatory Affairs will be responsible for...in Palo Alto, CA and reports directly to the Senior Director, Regulatory Affairs. Key Responsibilities +… 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 ... are uncommon in scale and scope. **Position Summary** The Senior Principal Scientist will serve as a drug product...and process development principles. + Experienced in building the CMC dossier for regulatory submissions as an… more
- BeiGene (San Mateo, CA)
- **General Description:** The Sr Manager of Clinical Supply Chain manages drug supply activities related to planning, label development, label & pack, and ... improvements to build the organization for the future. The Sr Manager of Clinical Supply Chain leads...high service level to internal stakeholders (eg Clinical Operations, Regulatory , Quality, CMC ). + Work with Clinical… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …well as other research areas centered around rare diseases and immune disorders. **Summary** The Regulatory Data Manager will be a key member of the Global ... As a result, this role will need to partner closely with teams and senior leaders from across Regulatory Affairs, as well as cross-functional stakeholders (eg,… more
- Merck (Boston, MA)
- …partner organizations such as Clinical Sciences and Study Management (CSSM), Regulatory , Chemistry, Manufacturing and Controls ( CMC ), Pharmaceutical Sciences, ... patient continuity of supply. Working independently, the Clinical Supplies Project Manager (CSPM) designs strategic and operational plans for all activities… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and help create possible, together. **Job Description** **Key Responsibilities** Senior Manager , Global External Manufacturing Biologics supports uninterrupted ... external contract manufacturing network, while ensuring compliance with cGMP, regulatory requirements, and environmental, health, and safety legislations. This… more
- Merck (North Wales, PA)
- …in the Research & Development organization at our company. **Position Description/Summary** The Senior Specialist, Project Manager is a core member of Early Drug ... integrating strategic and tactical input from diverse disciplines (eg, clinical, regulatory , market access, manufacturing, CMC , commercial, and other areas)… more
- Novo Nordisk (Boulder, CO)
- …of GMP manufacturing experience in the areas of biotechnology/pharmaceuticals. Relationships Senior Manager , Material Management. Essential Functions + Manage ... new laboratory completed in 2021 to support analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi… more
- RTX Corporation (Forest, MS)
- …United States of America Location: MS301: 19859 Highway 80, Forest 19859 Highway 80 CMC Forest, Forest, MS, 39074 USA Position Role Type: Onsite At Raytheon, the ... The successful candidate will interface with the Information Systems Security Manager (ISSM) to ensure adherence with NIST Special Publications, customer directives,… more
- BeiGene (San Mateo, CA)
- …regulatory compliance is always adhered to. The Logistics Manager will interface cross-functionally with Commercial Planning, Manufacturing, Procurement, QA ... **_General Description:_** The Logistics Manager is responsible for the planning, coordination and...courier vendor's performance and reports operational metrics (KPIs) to senior management, as well as any regulatory … more
- Gilead Sciences, Inc. (Foster City, CA)
- …35 countries worldwide, with headquarters in Foster City, California. ** Manager , Global External Manufacturing, Small Molecule Drug Substance** **KEY ... RESPONSIBILITIES** Manager , Global External Manufacturing, Small Molecule Drug Substance (DS) works to ensure uninterrupted supply of Gilead's clinical and… more