CMC Regulatory Lead - Cell Therapy & Viral Vectors (Hybrid)
Scorpion Therapeutics
Scorpion Therapeutics seeks a Lead CMC Regulatory Strategist to guide regulatory strategy for autologous T-cell and LVV programs, ensuring lifecycle management and global submissions across development stages. You will define CMC content, support process changes, and author regulatory documents for INDs, BLAs, and supplements, leading responses to health authority inquiries with a cross-functional team. #J-18808-Ljbffr Scorpion Therapeutics
- Role Lead CMC regulatory strategy and program leadership for cell therapy and viral vector products, including T-cell drug and LVV manufacturing. Objectives ensure regulatory... ...submissions and multi-site manufacturing WorkSetup hybrid model based in Santa Monica, CA, with...RegulatoryRelocationFlexible hours
$133.2k - $172.37k
...subsidiary, seeks a Manager in Regulatory Affairs focused on... ...Manufacturing, and Controls (CMC) for cell and gene therapies. The role involves preparing... ...to support lentiviral vector manufacturing compliance and... ...regulatory expectations for viral vector comparability and...Regulatory$143.23k - $185.35k
...Senior Manager of Regulatory Affairs Chemistry, Manufacturing, and Controls (CMC) at Kite, a Gilead company, leading regulatory strategy for CAR T-cell therapies and lentiviral vector manufacturing across early-stage through commercial phases. Responsibilities Lead...Regulatory$143.23k - $185.35k
...Senior Manager role supporting regulatory and chemistry, manufacturing, and controls (CMC) activities for Kite's cell therapy and CAR-T programs. The position manages complex submissions... ...manufacturing site expansion activities, vector-related changes, and inspection readiness...Regulatory$133.2k - $172.37k
...Manager, Regulatory Affairs CMC at Kite (Gilead Sciences) leads chemistry, manufacturing, and controls regulatory submissions for autologous CAR T-cell therapies in clinical development and commercial expansion. The role manages global CMC lifecycle, regulatory strategy...Regulatory$47.58 - $71.37 per hour
...Introduction We are seeking a Respiratory Therapy Supervisor with Los Robles Regional... ...maintained to quality control measures and CAP regulatory compliance You will ensure that the... ...required Minimum 2-years as lead or prior supervisor of RT department required...RegulatoryHourly payFull timeTemporary workPart timeFlexible hours- ...including document control, training, deviations, CAPA, and change control, while preparing for regulatory inspections. Reporting to the Senior Director, Quality Assurance, you will lead audits, support inspection readiness, and collaborate with #J-18808-Ljbffr Latigo...Regulatory
- ...Consultant - Contract to Hire, based in California. As a key member of the compliance team, you will provide expert guidance on regulatory compliance and lead efforts in risk management. Your role will involve working with various stakeholders to ensure compliance with...RegulatoryContract work
$19 - $22 per hour
...displayed at the store to support accurate pricing of products. Ensures any additional pricing tasks related to local regulations and/or regulatory compliance programs are completed accurately and within the required time frame. Assist with bookkeeping activities, including...RegulatoryHourly payWork experience placementSeasonal workLocal areaShift work$141.52k - $191.47k
...HCP engagement plans, in close partnership with product medical leads and field leadersAdapt strategies based on disease landscape... ...or clinical or research in the therapeutic areaFamiliarity with regulatory and legal frameworks governing scientific communications and affecting...RegulatoryFull timeRemote workFlexible hours$325.3k
...doLet’s do this. Let’s change the world. In this vital role you lead the U.S. Medical Affairs strategy for Amgen’s cardiovascular... ...External Engagement, Clinical Development, Commercial, Access, Regulatory, Legal, and Compliance to shape and execute an integrated U.S....RegulatoryFull timeFlexible hours- Kite Pharma seeks a Director of Submission Project Management to lead strategic planning and execution of major regulatory submissions globally. You will coordinate clinical data readiness, cross-functional teams, and governance to ensure timely, compliant filings. Prerequisites...Regulatory
- ...deliverables. You will collaborate across development programs, primarily in obesity-related areas, ensuring quality, timeliness, and regulatory readiness. The role requires strong SAS/R/Python skills, experience with SDTM/ADaM datasets, and leadership of both in-house and...Regulatory
- ...ensure safe, high-quality care, while aligning with established policies and procedures. The role includes leadership in performance evaluations, staff competencies, training, onboarding, and ensuring QA processes and regulatory #J-18808-Ljbffr UCLA Outpatient ClinicsRegulatory
$27 - $32 per hour
...timely payment of corporate and property invoices. The role supports multiple entities and handles journal entries and regulatory reporting. This hybrid position reports to the accounting team on-site Tuesday through Thursday with remote work Monday and Friday. The base...RegulatoryRemote jobHourly payMonday to FridayFlexible hours- A leading staffing agency is looking for a Study Lead Statistician to oversee statistical activities for clinical studies. This role... ...collaboration with cross-functional teams for results that meet regulatory standards. The ideal candidate holds a Master's or PhD in...RegulatoryRemote job
$237.58k - $307.45k
...pioneering personalized CAR T-cell therapies have changed the paradigm.... ...Access and is responsible for leading a newly formed strategic... ...portfolio growth. This is a hybrid position with three days per... ...Medical Affairs, Brand, Legal, Regulatory, and Compliance to ensure...RegulatoryFor contractorsLocal area3 days per week$175k - $264k
...the second year in a row. The Regional Lead is responsible for leading and managing... ...region’s market dynamics, client needs, and regulatory landscape, the Regional Lead ensures... ...agency. Any unsolicited submittals are done at the risk of the recruiter. #LI-Hybrid...RegulatoryWork at officeLocal areaFlexible hours- ...Oaks, CA is seeking an Associate Scientist PKMD Lab Operations to lead validation activities for computerized systems and maintain... ...owners, laboratory scientists, IT, quality, and vendors to ensure regulatory readiness and compliant data generation while supporting...Regulatory
$80 - $90 per hour
...· Westlake Village, California New U Therapy Center & Family Services is a thriving,... ...clients, not like a typical clinic. True hybrid flexibility — build a schedule that... ...organizational policy and professional/regulatory standards. Grow with your peers — take...RegulatoryHourly payPart timePrivate practice$124.3k - $168.16k
...Competitive Intelligence Manager, R&D - Hybrid - Thousand OaksThis position requires 2/3... ...you will be a part of a global team and lead intelligence gathering activities for R&D... ...experience working with proprietary technical, regulatory and financial data sources (i.e....RegulatoryFull timeFlexible hours$95 - $113.05 per hour
OverviewThe Study Lead Statistician (SLS) for product-facing work leads statistical activities for clinical studies. This role collaborates... ...studies are well-designed, statistically sound, compliant with regulatory standards, and aligned with internal practices. The SLS ensures...RegulatoryRemote jobTemporary workWork experience placementLocal area$230k - $290k
...ensuring clients stay ahead of regulatory changes. • Client... ...clients. • Cultivate new client leads through networking, industry events... ...year to take a vacation! • Hybrid Work (there will be times when... ...• Free Snacks & Beverages • Cell Phone Reimbursement •...RegulatoryCasual workWork at officeFlexible hours- ...coverings and other personal protective equipment (PPE) to prevent the spread of the COVID-19 or other communicable diseases, per regulatory guidelines. Oakmont Management Group, based in Irvine, California, is a recognized leader in the senior living industry that...RegulatoryRelocationAll shiftsFlexible hours
$211.41k - $286.02k
...(EHSS) organization. You will lead a highly specialized toxicology... ...safety, worker safety and regulatory compliance across our global operations... ...management. The role is hybrid, option for remote work may be... ...governance.Product Quality & CMC ToxicologyLead toxicological assessments...RegulatoryFull timeRemote workFlexible hours- ...Westlake Village, CA is seeking a Senior Manager, Regional FSQA to lead food safety and quality across North America, partnering with... ...problems, and translating priorities into rigorous execution, with a hybrid work arrangement in Westlake Village. #J-18808-Ljbffr Dole...
- ...in North America is seeking a Senior Manager, Regional FSQA to lead food safety and quality across North America, acting as the primary... ..., build capability, and ensure robust FSQA execution from a hybrid Westlake Village, CA office with three days in the office each week...Work at office
- Amgen seeks a Senior Manager, US Primary Market Research, to partner with Commercial teams and own the generation and interpretation of insights that inform brand strategy and execution. In a data‑driven environment, you will guide KPI definitions, ensure methodological...
- A pioneering technology firm based in California is seeking a Go-To-Market Lead to establish and scale their commercial presence. In this hybrid role, you will engage with technical customers, develop go-to-market strategies, and drive early revenue. Candidates should have...
$123k - $153k
...Position Home Health Certified Occupational Therapy Assistant (COTA) – Independent Contractor Compensation & Benefits Potential gross... ...efficiently in accordance with applicable payer, agency, and regulatory requirements. Communicate with the supervising OT, referring agency...RegulatoryFor contractorsRelocation packageFlexible hours
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