Global Regulatory Strategy Lead for Submissions
Exelixis Inc
Exelixis is seeking a Senior Regulatory Affairs role in California to develop and implement global regulatory strategies that align with asset and corporate goals. You will ensure timely preparation of organized submissions and translate regulatory requirements into practical plans. You will interact with authorities, lead cross-functional teams, review trial documentation, and coordinate submissions across regions while driving risk mitigation and ensuring high-quality messaging in all #J-18808-Ljbffr Exelixis
$157.5k - $222.5k
...Alameda, California, is looking for an Associate Regulatory Operations Director to oversee regulatory submission activities and ensure effective collaboration within... .... This position requires extensive knowledge of global regulatory requirements and involves managing...Regulatory- BeOne Medicines seeks an experienced regulatory affairs professional to manage,... ...plans and coordinates regulatory submissions, guiding cross-functional teams on strategy and tactics, and represents... ...Affairs on project teams. You will lead authoring and annual reporting, and...Regulatory
- ...leader in oncology, seeks an Executive Director, Regulatory Affairs to guide global regulatory strategies from early development through post-approval. You... ...oversee program leaders, ensure timely IND/NDAs/BLAs submissions, and maintain strong FDA relationships to...Regulatory
- ...biostatistics to develop and execute statistical strategy for clinical trials across all phases. You will design analyses, guide regulatory interactions, and manage external... ...deliverables and high-quality statistical outputs for NDA submissions. #J-18808-Ljbffr ExelixisRegulatory
$100k - $200k
Lead, Troubleshooting Strategy and Solutions Working at Abbott At Abbott, you can do work that matters,... ...stakeholders across Quality, Customer Service, Regulatory, Product Development, Data Analytics... ...routine fingersticks. CRM As a global leader in Cardiac Rhythm...RegulatoryWorldwide- ...outcomes with sponsors, internal partners, and external parties, leading cross-functional IPT workstreams and governance to ensure... ...manage end-to-end program execution from design through regulatory submission, balancing technical rigor with stakeholder alignment and risk...Regulatory
- ManpowerGroup Global, Inc. in Alameda, CA is seeking a Regulatory Specialist Sr to help ensure timely approval of medical devices and... ...teams to develop and implement regulatory strategies and provide expert guidance on submissions and labeling. The ideal candidate brings...Regulatory
- ...coordinate, and execute on-the-water operations for Saildrone’s global USV missions, translating customer objectives into executable... ...external stakeholders, driving mission success while ensuring safety, regulatory compliance, and operational clarity in a fast-paced, mission-...Regulatory
- Abbott Laboratories in Alameda, CA seeks a Lead, Troubleshooting Strategy & Solutions to drive the effectiveness and continuous improvement of Troubleshooting... ...on-site role partners with Quality, Customer Service, Regulatory, Product Development, Data Analytics, PMO, and BTS to...Regulatory
- Penumbra, Inc. in Alameda, CA seeks a Regulatory Affairs coordinator to help bring life-saving technologies to patients worldwide by preparing and maintaining document packages for regulatory submissions. You will assist in preparing submissions (510(k), CE/UKCA, IDE, non...RegulatoryWorldwide
- Abbott is seeking a senior portfolio leader to drive the Global Strategic Initiatives PMO. You will own governance, prioritization, and... ...tools, and marketing roadmaps. You will partner with BTS/IT, Regulatory, Quality, and Commercial teams to ensure alignment with strategic...Regulatory
$164.5k - $234.5k
...recruitment and retention strategy while ensuring adherence to global requirements and... ...forms and clinical trials. Leads a cross-functional governance... ...informed consent global submissions to integrate into... ...trials.Knowledge of GCP and regulatory requirements related to...RegulatoryFull timeWork at officeLocal areaWorldwideFlexible hours$268.5k - $380k
...: The Executive Director, Regulatory Affairs has oversight for... ...developing and implementing global regulatory strategies encompassing clinical, non... ...and scientifically valid submissions. Provides expertise in translating... ...Has extensive experience leading multiple projects...RegulatoryWork at officeLocal areaFlexible hours- ...Energy is building America’s energy future and is seeking an experienced supply chain professional to lead the development and execution of the global sourcing strategy for critical plastic components used in our iron‑air battery systems. The role reports to the Sr....
$195k - $277.5k
...the development and implementation of global regulatory strategies that align with asset and corporate... ...consistent, and scientifically valid submissions. Provides expertise in translating regulatory... ...work instructions and company SOPs. Lead multiple assets and/or studies as...RegulatoryWork at officeLocal areaFlexible hours$185k - $300k
...this role:Wells Fargo is seeking a Lead Treasury Management Consultant within Global Payments & Liquidity as a part of... ...recommend Treasury Management strategies that improve working capital, operational... ..., Financial Crimes, Operational, Regulatory Compliance), which includes...RegulatoryFull timeWork experience placement- ...senior Biostatistics leader to develop and oversee statistics strategies, tools, and processes for clinical trial data integrity and efficiency... ...and executives to shape drug development strategy and ensure regulatory compliance. The role requires 15+ years in biostatistics with...Regulatory
- Abbott is a global healthcare leader seeking a senior portfolio leader... ...portfolio, drive CAPA and regulatory initiatives, and guide on-... ...product changes. You will develop strategies, roadmaps, and ensure... ...across multiple domains. You will lead a global team of ~40...Regulatory
- Exelixis Inc. seeks a DMPK Director to lead ADME and modeling strategies across discovery to development, enabling regulatory submissions and robust translational science. You will ensure scientific accountability and strategic DMPK direction for multiple programs in Exelixis...Regulatory
- Penumbra, Inc. in Alameda, California seeks a Regulatory Submissions Coordinator to prepare and maintain document packages for worldwide regulatory... ...System, and help in-country RA personnel to facilitate global clearances. Occasional travel may be required. #J-18808-Ljbffr...RegulatoryWorldwide
- Abbott is a global healthcare leader improving lives through diagnostics... ...branded medicines. This role leads the global Compliance PM & ALD portfolio, driving CAPA, regulatory changes, labeling updates,... ...delivery while shaping strategies across Regulatory, Quality, R...RegulatoryWorldwide
$285k - $400k
...genome. The Role As Program Lead for MGX-001, you will drive the... ...the program's development strategy and integrated timeline, lead... ...product profile, the clinical and regulatory path to registration, and the... ...interactions, and the BLA submission itself as well as applications...RegulatoryLocal area- ...Senior Director, Clinical Operations to lead worldwide execution of oncology Phase... ...IV trials. You will drive operational strategy, ensure regulatory compliance, and manage resources and... ...vendors to deliver high-quality data for global registration and commercialization....RegulatoryWorldwide
- ...Senior Manager, Customer Supply Chain in Alameda, CA to lead supply chain operations for multiple product lines. You will... ...The role demands a strong background in medical devices, global leadership, and regulatory compliance within a matrixed organization. #J-18808-...Regulatory
- Just Food Company is seeking an experienced QA/QC Leader to own and scale the global Quality Management System across internal sites and co-manufacturers. You will drive regulatory leadership for North American and European operations and oversee audits, ensuring compliance...Regulatory
- ...partnering with the Head of Brand, you’ll own strategy, build plans, roll up your sleeves, and... ...and freelance partners, but you’ll lead from idea to launch. You’ll collaborate daily with Product Development, Sales, Regulatory, Quality, Operations, Finance, and Leadership...RegulatoryFreelance
$268.5k - $380.5k
...adversity. The success of our lead product has provided a solid... ...Commercial.As we expand our global partnerships and further reinvest... ...research and development strategies aligned with corporate objectives... ...translational medicine, CMC, regulatory, and clinical development....RegulatoryFull timeWork at officeLocal areaFlexible hours- Pyka seeks a seasoned Head of Supply Chain to lead global operations as we scale production of autonomous electric aircraft. You will... ...international logistics, and supplier relationships. You’ll shape teams, strategies, and ERP-driven processes, partnering with engineering,...
- ...workshop using existing shelving Coordinate global equipment delivery and returns Manage... ...Compliance team and 3PLs to ensure regulatory compliance of all international shipments... ...implement inventory movement optimization strategies (e.g., warehouse-slotting, route planning...RegulatoryLocal areaWorldwide
- GeneFab is seeking an experienced and dynamic Quality Regulatory Program Manager to lead our quality assurance and regulatory initiatives. You will... ...quality and patient safety. The role develops regulatory strategies for successful registration and lifecycle management of...Regulatory
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