Global Regulatory CMC Strategy Lead
Jobleads-US
CSL Behring is seeking a Regulatory Affairs CMC leader to partner with Global Regulatory Affairs, R&D, Quality and Global Operations to deliver compliant, innovative CMC strategies. You will oversee global CMC activities, facilitate digital innovations, and coordinate with outsourcing partners to ensure timely regulatory readiness.
The role requires a BS in biological or chemical sciences, 5+ years in regulatory roles in biologics or plasma, and strong cross-functional leadership.
#J-18808-Ljbffr Jobleads-US- ...Job Description Team Lead, Global Regulatory Affairs x 2 \n \n The Team Lead, Global Regulatory Affairs CMC - Biological & Non-Biol. Products is responsible for: \n... ...Affairs stakeholders to address regulatory strategy challenges and deliver innovative, timely...RegulatoryLocal areaFlexible hours
- ...seeking a Site Security Business Partner to lead and coordinate security programs across... ...5+ years of team management, and strong regulatory knowledge. The position requires on-site... ...PA and collaboration with CSL Plasma and global security teams. #J-18808-Ljbffr CSL Plasma...Regulatory
- ...affect millions worldwide. Our strategy is to develop medicines that... ...discovery, development, and regulatory approvals is evidenced in... ...strategic and hands-on Supply Chain Lead to lead global clinical supply operations... .... As a key member of the CMC Biologics team, you will...RegulatoryContract workWork at officeLocal areaWorldwideFlexible hours2 days per week
$258.83k - $293.48k
...connected by our shared purpose: leading the fight against MASH.... ...our workforce strategy to ensure we have the right... ...way.The Senior Director of Regulatory Affairs CMC provides highly strategic,... ...CMC-related topics.Provides global regulatory input and support...RegulatoryMinimum wageFull timeWork at officeLocal areaFlexible hours3 days per week- CSL Vifor is seeking a Global Occupational Health & Wellness Director to design and govern a worldwide OH strategy, covering injury and workers’ compensation, employee wellness,... ...potential placement in Australia. You will lead global programs, establish standards and governance...SuggestedWorldwide
- West Pharmaceutical Services, Inc is seeking a Senior Manager, Global Inventory to lead the strategy and governance for inventory across the West network. You will ensure alignment with service levels, working capital, and growth, coordinating with DDD, E&PC, West Vantage...
$190.8k - $300.3k
...Marketing, Lung, Gastrointestinal and Genitourinary Strategy Lead NOTICE FOR INTERNAL APPLICANTS: Please review the Global Job Posting and Employee Placement Policy... ...Access, Analytics, Commercial Operations, Regulatory, Legal, Finance, Field Sales, agency, and...RegulatoryFull timeFor contractorsLocal areaWorldwideRelocationVisa sponsorshipFlexible hoursShift work- A global pharmaceutical organization is seeking a Contractor Quality & Regulatory Lead to oversee product quality and compliance for external manufacturers. This role demands over 10 years of experience in GXP settings and requires expertise in regulatory affairs and quality...RegulatoryFor contractorsRemote work
- ...United States is seeking an Associate Director to lead external LM drug substance programs within our global CMO network. You will drive tech transfer, process... ...management for LM assets, coordinating across R&D, QA, regulatory and supply chain to ensure on-time delivery and...Regulatory
- ...world data (RWD) to generate real-world evidence (RWE) for trial design, regulatory submissions and safety signals. The role partners with cross‑functional teams to develop and optimize RWE strategies for priority assets, ensuring data‑driven decision making and a...Regulatory
- IQVIA is seeking a Site Activation Project Lead to direct and manage the strategic, operational, and financial delivery of activation... ...across regions. You will oversee Site ID/Selection, ethics, regulatory processes, and site contracting for assigned studies. The role...Regulatory
- GSK is seeking a Regulatory Project Manager, Strategy to provide CMC regulatory support for a portfolio of small‑molecule products across global markets. The role offers exposure to lifecycle management... ...growth opportunities. You will lead CMC strategy, prepare regulatory...Regulatory
- ...US seeks a Director/Toxicology Project Specialist to lead end-to-end non-clinical safety strategies across multiple projects. You will integrate data with CMC, regulatory, and clinical plans in a highly matrixed global environment, enabling faster drug development. Based...Regulatory
$142.4k - $224.1k
...DescriptionAssociate Principal Scientist, Regulatory CMC Digital InnovationRahway, NJ... ...Point, PAOur Company is a global health care leader with a... ...-Functional Collaboration: Lead and coordinate cross-... ...with broader enterprise digital strategies.Partner with the Regulatory CMC...RegulatoryFull timeFor contractorsSummer internshipLocal area- ...late-stage clinical development projects. You will lead programming tasks, develop analysis datasets, and deliver tables, listings, and figures for regulatory submissions. Responsibilities include coordinating a global programming team, ensuring quality and timeliness,...Regulatory
$258.83k - $293.48k
...Madrigal Pharmaceuticals seeks a Senior Director of Regulatory Affairs CMC to lead strategy and execution for chemical manufacturing and controls across... ...expertise in small molecule regulatory development and global health authority interactions. Responsibilities...Regulatory$177.3k - $206.85k
...Cytokinetics seeks a Senior Manager in Regulatory Affairs CMC to lead chemistry, manufacturing, and controls regulatory submissions and strategy execution. The role involves coordinating... ...dossiers and maintain compliance with global pharmaceutical standards for small...Regulatory- ...Description Job Description Our client, a leading global specialty chemicals company, has... ...disclosures. Monitor and analyze regulatory developments in securities law and corporate... ...to drive innovative solutions and strategies, and to appropriately balance risk...RegulatoryWork experience placementNight shift
- Blue Cross Blue Shield Global Solutions is seeking a Manager- Client Management to lead a world-class team focused on client satisfaction, persistence, and profitability... ...of business, prepare renewals, and communicate strategies with clients and brokers, driving retention and...
- ...seeks an experienced Senior Director for Bioprocessing and Purification Technologies (BPT) Global Planning and Logistics to lead end-to-end supply chain planning and logistics strategy. You will drive synchronization between production, inventory and international...
- West Pharmaceutical Services in Exton, PA seeks a Principal Specialist, Regulatory Affairs (Medical Devices) to influence regulatory strategies and oversee global submissions, including US FDA 510(k) and EU MDR documentation for new products and changes. The role partners...Regulatory
$131k - $210k
...are looking for a dedicated Lead Architect to join our talented... ...assure compliance with legal, regulatory, and IPS project requirements... ...Hathaway company, is a global leader in technical consulting... ...Management, Operations/Logistics Strategy and Planning, EPCMV, and Staffing...RegulatoryFor contractorsWork at officeFlexible hours$96.68k - $120.85k
Company DescriptionRamboll is a global architecture, engineering,... ...the selected candidate will lead and support multidisciplinary... ...investigation and remediation strategies, oversee field programs and data... ...deliverables, and support regulatory and client communications. You...RegulatoryFull timeWork at office- CSL Behring seeks a Global Occupational Health & Wellness Director to design, govern, and continually improve the global OH strategy, including injury management, workers’ compensation, employee... ...health and compliance. The role leads global teams, establishes standards,...
- Oracle Fusion Cloud - PLM - Workstream Lead Choosing Capgemini means choosing a company... ...product development, sourcing, quality, regulatory compliance, and commercialization processes... ...faster time-to-market while maintaining global safety, nutritional, labeling, and sustainability...Regulatory
- ...is seeking a VP Medicine Development Leader to strategically lead global development of medicines from PoC to first major market approvals... ...early 2029. The role emphasizes developing an evidence-based strategy and leading a multidisciplinary team to deliver value for...Relocation
- CSL Behring is seeking a Senior Pharmacovigilance professional in the United States to lead global PV activities, ensuring compliance with GxP and regulatory requirements. You will oversee signal detection, safety data analysis, and the preparation for regulatory inspections...Regulatory
- ...R&D and TechOps, translating scientific strategies into multi-year technology roadmaps and... ...cybersecurity, and compliance. You will lead cross-domain collaboration and build scalable... ...to support clinical development, regulatory and manufacturing needs. #J-18808-Ljbffr...Regulatory
- ...companies, academic institutions and regulatory agencies around the world. The Global Account Director (GAD) is the... ...the Right Opportunities ~ Lead discovery conversations that identify... ...Develop and execute opportunity strategies that address competitive position...RegulatoryLocal area
- ...seeks a Vice President to lead clinical development strategy and execution across therapeutic... ...-stage program oversight, regulatory interactions, and cross-... ...FDA, EMA, PMDA, and other global agencies; prepare and... ...development, biostatistics, CMC, regulatory, and safety...Regulatory
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