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
$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- ...seeks an Executive Director, Regulatory Affairs to oversee global regulatory activities... ...post- approval, developing strategies across clinical, non-... ...CMC disciplines. This role leads the regulatory program team... ...timely, high-quality submissions and effective agency interactions...Regulatory
- ...detect heart and lung disease - the leading causes of death globally. Our FDA cleared, industry leading... ...to market globally by leading regulatory strategy across the full product lifecycle.... ...company and drives highly coordinated submissions and approvals (FDA, CE Mark,...RegulatoryWork at office
- Exelixis seeks an Associate Regulatory Operations Director to oversee submission activity for our global portfolio, ensuring staffing and timely filings. The role requires deep knowledge of regulatory submission requirements and collaboration across Regulatory Affairs...Regulatory
- Ray Therapeutics, Inc. is seeking a Director of Regulatory Affairs to lead global regulatory strategy for clinical programs. Reporting to the Chief Regulatory... ...-functional teams to ensure compliance and timely submissions. This role requires 10-12+ years in biotech/pharma,...Regulatory
- ...Optimization in Emeryville, CA. This role involves leading SEO and SEM initiatives, managing global PPC campaigns, and analyzing performance using tools... ...and SEM with strong analytical skills, capable of developing strategies for optimization. #J-18808-Ljbffr Itlearn360
- 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...
$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$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...RegulatoryFull timeContract workWork at officeLocal areaFlexible hours- 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
- Exelixis, Inc. in Alameda, CA is seeking an Assoc Regulatory Affairs Strategy Director (Oncology) to lead global regulatory strategies, ensure timely submissions, and guide study teams. The role requires senior-level expertise in regulatory affairs and collaboration with...Regulatory
- Eko is seeking a Director of Regulatory Affairs to lead global strategy for SaMD and hardware. You will own FDA/CE/Health Canada submissions, shape regulatory pathways, and partner with R&D, Quality, and Commercial teams to accelerate compliant market access. You will build...Regulatory
- 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....
$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- ...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
- Epia Neuro in Alameda, CA is seeking a Director of Regulatory Affairs to lead and execute regulatory strategy for Class III implantable neurotechnology. You... ...pathway from early FDA engagement through IDEs and PMA submission. This role requires deep FDA knowledge, ISO...Regulatory
- ManpowerGroup Global, Inc. seeks a Regulatory Affairs Associate in Alameda, CA, to support the Regulatory Affairs team by ensuring compliance and collaborating on regulatory submissions. The ideal candidate holds a Bachelor's degree and has at least 2 years in regulated...Regulatory
- ...seeking a senior leader to drive the global Compliance PM & ALD portfolio, including CAPA, regulatory compliance, labeling changes,... ...initiatives. You will develop strategies, align resources, and oversee... ...partners. This role requires leading a ~40-member global team, strong...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$148.7k - $297.3k
...Date: 2026-07-29Abbott is a global healthcare leader that helps... ...spectrum of healthcare, with leading businesses and products in diagnostics... ....As a Manager Market Access Strategy & Pull through, you will be... ..., and HEOR, medical, Regulatory, Patient Services, Finance, Trade...RegulatoryWorldwide$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$172k - $245k
...is seeking a Senior Clinical Trials Manager to manage and lead the execution of clinical trials in Alameda, California. This... ...requires expertise in clinical operations, overseeing global study delivery strategies, and maintaining compliance with ICH/GCP guidelines. The ideal...$71.7k - $85.45k
...role, including your experience leading and facilitating complex and... ...The Project Manager, Strategy & Planning strengthens organizational... ...projects, internal events, regulatory compliance, or long-range planning... ...at The Zoo, locally and globally. This is demonstrated by a willingness...RegulatoryFull timeTemporary workWork at officeRemote workFlexible hoursShift work- 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
- ...Laboratories in Alameda, CA seeks a Sr. Quality Specialist to lead complex quality and regulatory initiatives that impact patient safety and business... ...regulatory reporting decisions, and the preparation of submissions such as MDRs, MedWatch, and Vigilance. It requires...Regulatory
- ...development and governance of biostatistics strategy, tools and processes for clinical trial... .... You will ensure data integrity and regulatory readiness while shaping drug... ...to design studies, oversee regulatory submissions, and drive efficiency. Strong leadership...Regulatory
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