Hybrid Regulatory CMC Manager, Global CAR‑T Submissions

Arcellx

Kite Pharma in Santa Monica, CA, seeks a Manager, Global Regulatory CMC to lead regulatory submissions and lifecycle management for its autologous CAR‑T portfolio across the US, EU and other regions. The role partners with Operations, Quality, Process Development and Regulatory Affairs to align strategy and execution. The position supports global site additions, changes and shelf-life extensions, with a planned relocation to Thousand Oaks, Foster City or El Segundo in 2027 and a hybrid policy #J-18808-Ljbffr Arcellx

Apply

Vacancy posted 18 hours ago

Similar jobs that could be interesting for youBased on the Hybrid Regulatory CMC Manager, Global CAR‑T Submissions in Santa Monica, CA vacancy

Manager, Regulatory Affairs CMC
...pioneering personalized CAR T-cell therapies have changed... ...is an office based/hybrid position. The Manager, Regulatory Affairs CMC is located in El Segundo... ...Support preparation and submission of CMC regulatory filings... ...ensuring alignment with global regulatory requirements...
Car
Full time
Contract work
For contractors
Work at office
Local area
Remote work
Relocation
Flexible hours
GILEAD Sciences
Santa Monica, CA
6 days ago
Sr Manager, Regulatory Affairs CMC
$143.23k - $185.35k
...our pioneering personalized CAR T-cell therapies have... ...Job DescriptionThe Senior Manager, Regulatory Affairs CMC supports and drives increasingly... ...and execution of global regulatory strategies, supports... ...to-end preparation of CMC submissions, and partners closely with...
Car
Full time
For contractors
Work at office
Local area
Remote work
Relocation
Flexible hours
Shift work
GILEAD Sciences
Santa Monica, CA
3 days ago
Sr Manager, Regulatory Affairs CMC
...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 across clinical and commercial development... ...Develop and execute global CMC regulatory...
Car
Gilead Sciences
Santa Monica, CA
9 days ago
Sr Manager, Regulatory Affairs CMC
...Senior Manager of Regulatory Affairs Chemistry, Manufacturing, and Controls (CMC) at Kite, a Gilead company, leading... ...regulatory strategy for CAR T-cell therapies and... ...Lead integrated global CMC regulatory strategies... ...CMC content for IND submissions, amendments, BLA/MAA...
Car
Gilead Sciences
Santa Monica, CA
9 days ago
Sr Manager, Regulatory Affairs CMC
$143.23k - $185.35k
...pioneering personalized CAR T-cell therapies have... ...Responsibilities Regulatory Strategy and Program Leadership... ...or support integrated global CMC regulatory strategies... ...requirements, submission plans, health authority... ...development and lifecycle management of the T-cell control...
Car
Full time
For contractors
Work at office
Local area
Remote work
Relocation
Flexible hours
Gilead Sciences
Santa Monica, CA
17 days ago
Manager, Regulatory Affairs CMC
$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...
Car
Gilead Sciences
Santa Monica, CA
14 days ago
Sr Manager, Regulatory Affairs
...pioneering personalized CAR T-cell therapies have... ...Develop and implement regulatory product... ..., prepare, and review submissions to required authorities... ...regulatory authoritiesTrain, manage, and mentor other regulatory... ...and understanding of global regulations and guidelinesPrevious...
Car
Full time
For contractors
Work at office
Local area
Remote work
Relocation
Flexible hours
GILEAD Sciences
Santa Monica, CA
6 days ago
Director, Global Regulatory Affairs
$180k - $230k
Position: Director, Global Regulatory Affairs Department: Development - Regulatory... ...registration and lifecycle management. The Director, Global... ...Development, Nonclinical, CMC, Safety, Biostatistics, and... ...direction of major regulatory submissions, including INDs, CTAs, amendments...
For contractors
Remote work
Work from home
Overseas
Angitia Biopharmaceuticals
Los Angeles, CA
5 days ago
Manager, Regulatory Affairs CMC
...Gilead subsidiary, seeks a Manager in Regulatory Affairs focused on Chemistry... ...Manufacturing, and Controls (CMC) for cell and gene therapies... ...involves preparing regulatory submissions, developing CMC strategies,... ...3 content aligned with global regulatory requirements for...
Gilead Sciences
El Segundo, CA
9 days ago
Senior Director, Regulatory Affairs Strategy - Cell Therapy
$218.06k - $327.09k
...role: Are you ready to set the global regulatory vision for pioneering cell... ...current stage through BLA submission, ensuring an efficient route... ...regulatory objectives with clinical, CMC, safety and commercial... ....Delivery and Milestone Management: Oversee all regulatory deliverables...
Hourly pay
Full time
Temporary work
Start working today
Work at office
Flexible hours
3 days per week
AstraZeneca
Santa Monica, CA
5 days ago
Strategic Global Commercial Counsel Director (Hybrid)
...seeking an experienced Director, Commercial Counsel to support global operations and partner with senior executives and stakeholders to... ...complex commercial, technology, and strategic agreements. In this hybrid role, you will lead contract negotiations, modernize Viking’s...
Contract work
Viking
Los Angeles, CA
2 days ago
Director, Global Value & Access Strategy (Cell-Therapy Autoimmune)
$205.62k - $266.09k
...pioneering personalized CAR T-cell therapies have... ...are seeking a Director, Global Value & Access Strategy... ...role will be office-based/hybrid (3 days onsite) in El... ...HEOR/RWE, Commercial, Regulatory Affairs and regional Access... ...launch and lifecycle management. ~ Ensure payer,...
Car
Full time
For contractors
Work at office
Local area
Gilead Sciences
El Segundo, CA
2 days ago
Regulatory QA Manager - FDA Submissions & Compliance
Grifols is seeking a Quality Assurance Technical Manager in California to lead FDA submissions and coordinate technical documentation to meet timelines.... ...across the QA function. The role requires 5+ years in QA/regulatory fields, strong technical writing, and ability to work...
Grifols, S.A
Los Angeles, CA
4 days ago
Director, Regulatory Affairs (Global Regulatory Advertising and Promotion)
Director, Regulatory Affairs (Global Regulatory Advertising and Promotion) *Open to onsite in either Pasadena, CA or San Diego, CA* The... ...balance, substantiation requirements, and risk mitigation. Manage all submissions to FDA Office of Prescription Drug Promotion (OPDP) and...
Work at office
Local area
ALKU
Los Angeles, CA
3 days ago
CAR-T Translational Scientist - Multiple Myeloma (Hybrid)
...Scientist for Translational Medicine focused on Multiple Myeloma CAR-T programs. Hybrid, contract role with PK/PD leadership to guide clinical... ...industry or equivalent education with clinical trial and regulatory experience, plus strong background in cancer immunotherapy....
Car
Contract work
Pacer Group
Santa Monica, CA
5 days ago
Director of Global Regulatory Labeling & Strategy
Arrowhead is seeking a Director of Regulatory Affairs to lead global labeling strategy and end-to-end labeling execution. This role partners with product, clinical development, medical, market access, and commercial teams to ensure compliant, timely labeling across geographies...
ALKU
Los Angeles, CA
4 days ago
Associate Director/ Director, Regulatory Affairs (Global Regulatory Advertising and Promotion)
Role Associate Director of Regulatory Affairs for Advertising and Promotion, focusing on... ...promotional review committees (MLR) manage FDA submissions (FDA 2253) monitor industry enforcement... ...in specialty, rare disease, oncology global promotional regulatory experience fast...
Arrowhead Pharmaceuticals, Inc.
Los Angeles, CA
4 days ago
Global Cell Therapy Supply Planning Lead
...AstraZeneca plc seeks a Global Product Planner to shape the integrated supply chain strategy... ...in clinical development. You will connect CMC, Clinical Operations, Technical Operations... ...MD, you will lead the product-level S&OP, manage supply risks, coordinate with sites and...
Jobleads-US
Los Angeles, CA
5 days ago
Senior Director, Clinical Development
...pioneering personalized CAR T-cell therapies... ...study reports, regulatory documents, and... ...interactions and submissions, including INDs, health... ...Affairs, and CMC teams to advance development... ...interactions with global health authorities... ..., effectively managing competing...
Car
Full time
For contractors
Local area
Kite Pharma
Santa Monica, CA
5 days ago
Global Experiential Marketing Manager
$210k - $259k
...start as the Google Self-Driving Car Project in 2009, Waymo has... ...growing user base. In this hybrid role based in Los Angeles or New... ...York, you will report to the Global Experiential Marketing Lead.... ...communication to execute at speed. Manage program budgets with attention...
Car
Full time
Contract work
Remote work
Shift work
Latent Logic
Los Angeles, CA
4 days ago
Senior Manager, Global Commercial Strategy
...healthy products that support healthier lifestyles. The Senior Manager, Global Commercial Strategy plays a senior operating role in... ...will be based at our West Los Angeles, CA office. We work a hybrid schedule with an in-office requirement Monday-Wednesday and the...
Work at office
Remote work
The Wonderful Company LLC
Los Angeles, CA
1 day ago
Transaction Coordinator - Sotheby's International Realty - Los Angeles, CA (Brentwood) - Hybrid
..., clients, escrow companies and property management companies, the Transaction Coordinator is... ..., possessing strong working knowledge of CAR (California Association of Realtors) contracts... ...Transaction Coordinator role offers a hybrid work schedule with 3 days per week onsite...
Car
Work from home
3 days per week
Anywhere Real Estate
Santa Monica, CA
5 days ago
QA Regulatory Lead - Pharma Submissions & Compliance
...Angeles is seeking an experienced Quality Assurance Technical Manager to lead regulatory submissions and ensure compliant technical documentation. You will... ...and excellent technical writing. Join Grifols and contribute to global healthcare leadership. #J-18808-Ljbffr Grifols
Grifols
Los Angeles, CA
4 days ago
Global Legal Director: Strategy, Compliance & Growth
Cider seeks a senior legal leader to shape and run our global legal strategy from Los Angeles, coordinating cross-border compliance, IP... ...privacy while enabling growth with strong risk controls. You will manage external counsel across China, North America, Europe and the UK,...
Cider
Los Angeles, CA
18 hours ago
Hybrid Finance Manager: Strategic Analysis Leader
A global professional services firm is seeking a Finance Manager to provide financial analysis and strategy support. The role involves managing finance-related projects... ...position offers a flexible working schedule in a hybrid work environment. #J-18808-Ljbffr Consultative...
Flexible hours
Consultative Search Group
Los Angeles, CA
2 days ago
Director, Business Strategy and Operations
$205.62k - $266.09k
...breakthroughs and our pioneering personalized CAR T-cell therapies have changed the... ...reports to the Vice President and General Manager, US Commercial, and serves as a strategic... ...Represent US Commercial in enterprise and global planning forums, shaping broader decisions...
Car
Full time
For contractors
Work at office
Local area
Remote work
Relocation
Flexible hours
Kite Pharma
Santa Monica, CA
2 days ago
Associate Manager, Global Sourcing
$95k - $115k
...communities, and the planet.The Associate Manager, Global Sourcing will manage a diverse portfolio... ...West Los Angeles, CA office. We work a hybrid schedule with an in-office requirement... ...hotels, offsite venues, airlines, and rental car providers. Partner with internal...
Car
Contract work
Work experience placement
Work at office
Local area
Remote work
Worldwide
The Wonderful Company
Los Angeles, CA
3 days ago
Manager, Regulatory & Technical Writing, Process Sciences, Analytics and Technology, Cell and Gene Therapy
$136.78k - $205.18k
...digital technologies, and regulatory excellence to deliver... ...medicines. As Manager, Regulatory & Technical... ...in translating complex CMC and technical data into... ..., compelling, and submission-ready regulatory documentation... ...to BLA readiness, global regulatory submissions...
Contract work
Temporary work
Immediate start
Los Angeles, CA
7 days ago
Senior Regulatory Affairs Manager - Digital Solutions (on-site)
$130.7k - $261.3k
Abbott is a global healthcare leader that helps people live more fully at all stages... ...We are recruiting for a Senior Regulatory Affairs Manager to join our Digital Solutions team on... ...responsible for compiling regulatory submissions and ensure data is effectively presented...
Work experience placement
Worldwide
Abbott
Los Angeles, CA
3 days ago
Senior Manager, Compliance and Privacy
$136.1k - $156.7k
...to meet with you!The Senior Manager, Compliance and Privacy, drives... ...and addressing emerging regulatory and reputational risks. This... ...Washington, D.C., to comply with our hybrid work policy of 2-3 days per... ...expertise you bring to our global team while supporting your long...
Full time
Work at office
Local area
Remote work
Relocation package
2 days per week
3 days per week
Cornerstone Research
Los Angeles, CA
2 days ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Hybrid Regulatory CMC Manager, Global CAR‑T Submissions. Be the first to apply!