Global Regulatory Strategy Leader
Biopharma Careers
Exelixis is seeking an Executive Director of Regulatory Affairs to lead global regulatory strategies across clinical, non-clinical and CMC disciplines from early development through post-approval. The role requires extensive FDA interaction, high-level leadership of regulatory teams, and oversight of IND/NDAs/BLAs submissions to expedite approvals while ensuring compliance and high-quality documentation. #J-18808-Ljbffr Biopharma Careers
- 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...Regulatory
- Exelixis, Inc. seeks an Executive Director of Regulatory Affairs to oversee all regulatory activities from pre-IND through BLA/NDA and post-approval. Lead global regulatory strategies across clinical, non-clinical, and CMC disciplines, translating requirements into practical...Regulatory
- Exelixis, a leader in oncology, seeks an Executive Director, Regulatory Affairs to guide global regulatory strategies from early development through post-approval. You will oversee program leaders, ensure timely IND/NDAs/BLAs submissions, and maintain strong FDA relationships...Regulatory
- Exelixis is seeking a senior Biostatistics leader to develop and oversee statistics strategies, tools, and processes for clinical trial data integrity and... ...executives to shape drug development strategy and ensure regulatory compliance. The role requires 15+ years in...Regulatory
$100k - $200k
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio... ...DESCRIPTION: Lead, Troubleshooting Strategy and Solutions Working at Abbott... ...across Quality, Customer Service, Regulatory, Product Development, Data Analytics,...RegulatoryFull timeWorldwideShift work- Abbott is seeking a senior portfolio leader to drive the Global Strategic Initiatives PMO. You will own governance, prioritization, and the operating... ..., and marketing roadmaps. You will partner with BTS/IT, Regulatory, Quality, and Commercial teams to ensure alignment with...Regulatory
- Abbott, a global healthcare leader, invites you to join the Capital Procurement team in Alameda, CA. You will support capital equipment expansion, develop category strategy, manage SRM, and collaborate with Operations and Engineering to forecast automation needs. This...
- 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
- ...Alameda, CA is seeking an experienced leader to drive a portfolio of New Product... ...development through launch across global markets, aligning with strategy and roadmaps in a highly matrixed... ...cross-functional teams including R&D, Regulatory, Quality, and Commercial. #J-1880...Regulatory
$157.5k - $222.5k
Exelixis Inc in Alameda, California, is looking for an Associate Regulatory Operations Director to oversee regulatory submission activities... ...teams. This position requires extensive knowledge of global regulatory requirements and involves managing submission processes...Regulatory- Abbott Laboratories is seeking a Manager Market Access Strategy & Pull Through to lead payer and access marketing initiatives for the... ...across the commercial organization and partner with HEOR, medical, regulatory, and other teams to secure and optimize product access. The...Regulatory
$195k - $277.5k
SUMMARY/JOB PURPOSE: Responsible for the development and implementation of global regulatory strategies that align with asset and corporate goals as well as health authority requirements. Ensures timely preparation of organized, consistent, and scientifically valid submissions...RegulatoryFull timeWork at officeLocal areaFlexible hours- Abbott Laboratories in Alameda, CA seeks a Lead, Troubleshooting Strategy & Solutions to drive the effectiveness and continuous... ...Codes. This on-site role partners with Quality, Customer Service, Regulatory, Product Development, Data Analytics, PMO, and BTS to identify...Regulatory
- Exelixis in Alameda, CA, USA seeks a leader in biostatistics to develop and execute statistical strategy for clinical trials across all phases. You will design analyses, guide regulatory interactions, and manage external partners to advance oncology programs with strong...Regulatory
$268.5k - $380.5k
...Commercial.As we expand our global partnerships and further reinvest... ...research and development strategies aligned with corporate objectives... ...with cross-functional leaders to identify, evaluate, and advance... ...translational medicine, CMC, regulatory, and clinical development....RegulatoryFull timeWork at officeLocal areaFlexible hours$164.5k - $234.5k
...the implementation of the recruitment and retention strategy while ensuring adherence to global requirements and guidelines across our informed consent... ...for clinical trials.Knowledge of GCP and regulatory requirements related to conducting clinical trials worldwide...RegulatoryFull timeWork at officeLocal areaWorldwideFlexible hours$268.5k - $380k
...JOB PURPOSE: The Executive Director, Regulatory Affairs has oversight for all regulatory... ...for developing and implementing global regulatory strategies encompassing clinical, non-clinical and... ...and management of Regulatory Program Leaders and their staff. Oversee the development...RegulatoryWork at officeLocal areaFlexible hours- ...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. Manager of Global Supply...
- 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...
$148.7k - $297.3k
...AmericaTime Type: Full timeAbbott is a global healthcare leader that helps people live more fully at... ....As the Senior Procurement Manager, Strategy & New Product Introduction (NPI), you... ...dependencies, business continuity, and regulatory compliance.Lead cost reduction and...RegulatoryContract workWorldwideShift work$153k - $210k
...Lead will be an experienced Integration Strategy Architect with deep expertise in designing... ...-state architectures.• Knowledge of regulatory and audit requirements (SOX, SOC- as applicable... ....• Experience working in large-scale, global enterprise environments.• Medical device...RegulatoryTemporary workWork at officeLocal area- ...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
- ...a Director of Innovation Product Marketing to lead the global product marketing strategy and the innovation pipeline for the e.l.f. brands. The role... ...partnering with Product Development, Sales, Education, Regulatory, and other teams to deliver successful launches. #J-18...Regulatory
- ...governance to ensure transparent decisions and on-time delivery. You will manage end-to-end program execution from design through regulatory submission, balancing technical rigor with stakeholder alignment and risk management, in a fast-paced biotech environment. #J-18...Regulatory
- ...below, this senior technical/functional leader role is also responsible for developing... ...operational needs; translates business strategy into actionable business requirements; develops... ...with local, state, federal, and other regulatory requirements.Develops and grows...RegulatoryTemporary workLocal area
- Exelixis seeks a leader to drive the global informed consent program, ensuring alignment with regulatory standards and trial requirements. You will manage cross-functional governance with internal teams, CROs, vendors, and sites to meet enrollment and retention goals. You...Regulatory
- Exelixis is seeking a senior biostatistics leader to drive statistical strategy and design for oncology clinical trials across all phases. You will... ...reporting. The role requires extensive experience in CDISC, regulatory guidelines, and leadership of cross-functional teams,...Regulatory
$148.7k - $297.3k
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio... ...levels. As a Manager Market Access Strategy & Pull through, you will be... ...commercial operations, and HEOR, medical, Regulatory, Patient Services, Finance, Trade,...RegulatoryWorldwide$148.7k - $297.3k
Abbott Laboratories in Alameda is seeking a Senior Manager for Forecasting and Strategy. This role involves leading the forecasting team to support business objectives and shaping commercial strategy with actionable insights. The successful candidate will have strong experience...- 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...
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