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
- Exelixis Inc in Alameda, CA is seeking a Regulatory Affairs leader to develop and implement global regulatory strategies that align with asset and corporate goals and health... ...of organized, scientifically valid submissions and communicate regulatory plans to stakeholders...Regulatory
- Abbott in Alameda, CA is seeking a Regulatory Affairs Manager to combine... ...expertise to enable products to meet global regulations. You will compile regulatory submissions and ensure data is presented... ...development of regulatory strategies, coordination with Marketing for...RegulatoryWorldwide
$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- ...Inc. seeks an Executive Director of Regulatory Affairs to oversee all regulatory... ...through BLA/NDA and post-approval. Lead global regulatory strategies across clinical, non-clinical, and... ...plans and guiding timely, high-quality submissions. You will mentor the regulatory...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
- Abbott, a global healthcare leader, invites you to join the Capital Procurement team in Alameda... ...equipment expansion, develop category strategy, manage SRM, and collaborate with... ...offers travel up to 20% and opportunities to lead international negotiations. A Bachelor's...
- Meyer Sound in Berkeley, CA is seeking a Regulatory Compliance Manager to coordinate safety, environmental... ..., sustaining engineering, manufacturing, and global certification programs. Reporting to the Director of Knowledge Strategy & Enablement, you will work with engineering,...Regulatory
- ...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
- Abbott Laboratories is seeking a Manager Market Access Strategy & Pull Through to lead payer and access marketing initiatives for the Diabetes portfolio... ...commercial organization and partner with HEOR, medical, regulatory, and other teams to secure and optimize product access....Regulatory
$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...RegulatoryFull timeWork at officeLocal areaFlexible hours- 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- ...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....
- Abbott Laboratories seeks a Senior Regulatory Affairs Specialist for Lingo in Alameda, CA... ...with product teams to ensure compliant submissions and labeling throughout development and... ...cross-functional leadership, regulatory strategy, and robust documentation to meet...Regulatory
$153k - $210k
.../On-siteAs a BI Integration Lead at Penumbra, you will play a... ...be an experienced Integration Strategy Architect with deep expertise... ...architectures.• Knowledge of regulatory and audit requirements (SOX,... ...Experience working in large-scale, global enterprise environments.•...RegulatoryTemporary workWork at officeLocal area$268.5k - $380k
...PURPOSE The Executive Director, Regulatory Affairs has oversight for... ...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- ...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
$120k - $160k
...business enterprise providing global consulting & staffing... ...organization is the functional lead for the procurement of materials... ...the sourcing and procurement strategy for one of the nation’s largest... ...align with business objectives, regulatory requirements, and industry...RegulatoryFull timeContract workWork experience placementWork at office$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,...
- ...Experience conducting market research, customer discovery, or product strategy work ~ Strong analytical, presentation, and stakeholder... ...& Skills: Experience with California energy markets and regulatory environments Familiarity with CAISO, resource adequacy, demand...RegulatoryFor contractorsFlexible hours
- ...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
$148.7k - $297.3k
...AmericaTime Type: Full timeAbbott is a global healthcare leader that helps... ...spectrum of healthcare, with leading businesses and products in... ...Senior Procurement Manager, Strategy & New Product Introduction (... ..., business continuity, and regulatory compliance.Lead cost...RegulatoryContract workWorldwideShift work$125k - $175k
...technical expertise and keen awareness of the regulatory framework to achieve our clients'... ...Senior Hazardous Materials Practitioner to lead our hazardous materials management... ...environmental impact assessments, and regulatory submissions related to hazardous materials...RegulatoryLocal areaFlexible hours- ...seeking a Director of Innovation Product Marketing to lead the global product marketing strategy and the innovation pipeline for the e.l.f. brands. The... ...partnering with Product Development, Sales, Education, Regulatory, and other teams to deliver successful launches. #J-...Regulatory
- ...readiness from development through launch across global markets, aligning with strategy and roadmaps in a highly matrixed... ...strong communication, and proven ability to lead cross-functional teams including R&D, Regulatory, Quality, and Commercial. #J-18808-Ljbffr...Regulatory
- ...A leading IT staffing company in Emeryville is looking for a qualified candidate to support the maintenance of their Global Regulatory Affairs filing system and RTS database. The role emphasizes effective organization, knowledge of compliance, and project execution skills...RegulatoryWork at office
- ...seeking a Sr. Quality Specialist to drive complex quality and regulatory initiatives impacting patient safety and business operations. You will lead complaint assessments, regulatory reporting decisions, and submissions such as MDRs, MedWatch, and Vigilance while...Regulatory
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