Global Regulatory Strategy Director: Submissions Lead
Exelixis Inc
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 authority requirements. You will ensure timely preparation of organized, scientifically valid submissions and communicate regulatory plans to stakeholders to mitigate risk. The role requires a high degree of regulatory expertise, leadership in cross-functional teams, and the ability to manage multiple development programs #J-18808-Ljbffr Exelixis Inc
- Exelixis, a leader in oncology, seeks an Executive Director, Regulatory Affairs to guide global regulatory strategies from early development through post-approval.... ...program leaders, ensure timely IND/NDAs/BLAs submissions, and maintain strong FDA relationships to accelerate...Suggested
- Exelixis, Inc. seeks an Executive Director of Regulatory Affairs to oversee all regulatory... ...BLA/NDA and post-approval. Lead global regulatory strategies across clinical, non-clinical, and... ...and guiding timely, high-quality submissions. You will mentor the regulatory team...Suggested
$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...SuggestedFull timeWork at officeLocal areaFlexible hours- Exelixis is seeking a Senior Regulatory Affairs role in California to develop and implement global regulatory strategies that align with asset and... ...preparation of organized submissions and translate regulatory... ...interact with authorities, lead cross-functional teams, review...Suggested
- 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...Suggested
$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...- Exelixis, Inc. is seeking an Associate Regulatory Operations Director in Alameda, CA. This role is responsible for overseeing submission activities and managing the submission forecast. The ideal candidate will have substantial experience in regulatory operations and will...
$268.5k - $380k
...JOB 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...Work at officeLocal areaFlexible hours- Exelixis Inc. seeks a senior leader to drive recruitment and retention governance for informed consent across global clinical trials. You will align policy with external regulations and collaborate with CROs, vendors, and site teams to meet enrollment goals. You will guide...
- ...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 Exelixis
- 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...
- 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,...
- Architect Motors is building an affordable electric motorcycle for emerging markets, seeking a Global Supply Manager to own supplier and manufacturing relationships in China. You will drive sourcing, OEM/ODM management, and future vehicle programs from development through...
- ...Nutrition Company (PNC) seeks a Regulatory Affairs Manager to lead regulatory strategy for Premier Nutrition’s products... ...international markets. You’ll navigate global regulations, ensure labeling... ...compliant claims, reporting to the Director of Regulatory Affairs. Based in...
$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...Full timeWork at officeLocal areaWorldwideFlexible 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...
$114k - $228k
...HealthcarePosted Date: 2026-08-18Abbott is a global healthcare leader that helps people live... ...spans the spectrum of healthcare, with leading businesses and products in diagnostics,... ...capabilities. The role connects marketing strategy with technology execution by defining capability...Worldwide- ...Group is seeking a Senior Accountant to support revenue accounting, month-end close, and international audit activities within our global organization. The role requires strong technical accounting knowledge and the ability to partner with finance, operations, and external...
$157.5k - $222.5k
...PURPOSE: The Associate Regulatory Operations Director is responsible for overseeing submission activity for the... ...in-depth knowledge of global regulatory submission... ...impact due to changes in strategy and/or timelines are assessed... ...and management. Leads a cross-functional team...Full timeWork at officeLocal areaFlexible hours$114k - $228k
...Full timeAbbott is a global healthcare leader that... ...spectrum of healthcare, with leading businesses and... ...are recruiting for a Regulatory Affairs Manager to join... ...compiling regulatory submissions and ensure data is effectively... ...s).Develop regulatory strategies, approval schedules,...WorldwideShift work$248k - $352.5k
...the development and implementation of global regulatory strategies that align with asset and corporate... ...consistent, and scientifically valid submissions. Provides expertise in translating regulatory... ...objectives and regulatory strategy. Lead, author and evaluate documents...Full timeContract workWork at officeLocal areaFlexible hours$114k - $228k
...Full timeAbbott is a global healthcare leader that... ...spectrum of healthcare, with leading businesses and... ....The Opportunity This Regulatory Affairs Manager - APAC... ...robust global regulatory strategies, working with cross-... ...compiling regulatory submissions, and ensuring data is...Shift work$114k - $228k
...Full timeAbbott is a global healthcare leader that... ...spectrum of healthcare, with leading businesses and... ...sensing technology. This Regulatory Affairs Manager... ...talent, shape regulatory strategy, and partner across functions... ...on FDA pathways, submissions, and interactions, including...Shift work$168.9k - $281.7k
...creating software trusted by over 90% of leading industrial companies.Salary Range:$168,... ...educational attainment and/or training.Director, Global Practice Lead — PI Data Infrastructure... ...practice worldwide. You will lead the strategy, the teams, and the emerging industry enablement...Full timeWork at officeLocal areaRemote workWorldwideFlexible hours$120k - $135k
...re interested in… The Regulatory Affairs Manager will provide... ...and navigate the global regulations for Canada... .... Reporting to the Director of Regulatory Affairs,... ...organization of regulatory submission documentation to... ...Act as the regulatory lead in change control reviews...Temporary workCasual workWork at officeLocal areaDay shift- ...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....
- 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,...
- Form Energy is looking for a Supply Chain Manager for metal parts to shape a global sourcing strategy. This hybrid role in Berkeley requires strong negotiation skills and a deep understanding of sourcing processes. With 7+ years of experience, you will negotiate favorable...
- Saildrone is seeking a Senior Global Supply Manager to own end-to-end sourcing and supply chain strategy for critical commodities across hardware manufacturing. You will bridge Engineering, NPI, and Production to ensure high-quality products delivered on time and at target...
- Pyka is seeking a seasoned Head of Supply Chain to lead global supply chain operations as we scale production of autonomous electric aircraft. You will oversee procurement, inventory, international logistics, and vendor relationships to ensure cost-effective, reliable operations...
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