Sr Manager, Regulatory Affairs CMC
$143.23k - $185.35kGilead
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 integrated global CMC regulatory strategies for T-cell drug products and lentiviral vectors
- Develop phase-appropriate control strategies, specifications, and testing requirements
- Assess manufacturing process changes and determine regulatory impact and acceptance criteria
- Guide CMC content for IND submissions, amendments, BLA/MAA filings, and post-approval changes
- Support manufacturing site additions, technology transfers, and process performance qualification
Requirements
- Extensive experience in CMC regulatory strategy for cell or gene therapies
- Deep knowledge of T-cell manufacturing processes and controls
- Expertise in lentiviral vector regulatory pathways and comparability
- Experience with IND, BLA/MAA submissions and health authority engagement
- Strong understanding of process validation, analytical methods, and stability testing
- Leadership experience managing cross-functional regulatory programs
- Proven ability to translate technical decisions into regulatory requirements
Vacancy posted 7 days ago
Similar jobs that could be interesting for youBased on the Sr Manager, Regulatory Affairs CMC in Foster, CA vacancy
$143.23k - $185.35k
...LeadershipLead or support integrated global CMC regulatory strategies for both T-cell drug product... ....Guide development and lifecycle management of the T-cell control strategy, including... ...experience.Significant Regulatory Affairs CMC experience in biotechnology or biopharmaceutical...SeniorFull timeFor contractorsWork at officeLocal areaRemote workRelocationFlexible hoursKite Pharma
Foster, CA1 day ago$133.2k - $172.37k
...Join Kite and help create more tomorrows.Job DescriptionThe Manager, Global Regulatory CMC will support Kite’s autologous CAR T cell therapy... ...Development, Analytical, Manufacturing, and Global Regulatory Affairs.Kite is transitioning from its current Santa Monica headquarters...SuggestedFull timeFor contractorsWork at officeLocal areaRemote workRelocationFlexible hoursKite Pharma
San Mateo, CA4 days ago- ...include but are not limited to):Develop and implement regulatory product strategiesRepresent the regulatory function... ...requests for information from regulatory authoritiesTrain, manage, and mentor other regulatory affairs personnelWork externally to engage in regulatory...SeniorFull timeFor contractorsWork at officeLocal areaRemote workRelocationFlexible hours
GILEAD Sciences
San Mateo, CA2 days ago $230k - $270k
...AlloCAR T) products for cancer and autoimmune disease. Led by a management team with significant experience in cell therapy, Allogene... ...is seeking a highly motivated Senior Director, CMC Regulatory Affairs in the Global Regulatory Affairs and Clinical Quality group...SeniorFull timeContract workInternshipLocal areaRemote work2 days per weekAllogene Therapeutics
South San Francisco, CA11 days ago$280k - $310k
...POSITION SUMMARYThe Senior Director, Global Regulatory Affairs will play a significant role in... ...limited to IND, NDA, MAA, and life cycle management activities for multiple projects. JOB FUNCTIONS... ..., Regulatory Labelling and Regulatory CMC, oversees the development of content...SeniorOdd jobLocal area2 days per weekMirum Pharmaceuticals
Foster, CA4 days ago$133.2k - $172.37k
...Kite, a Gilead subsidiary, seeks a Manager in Regulatory Affairs focused on Chemistry, Manufacturing, and Controls (CMC) for cell and gene therapies. The role involves preparing regulatory submissions, developing CMC strategies, and collaborating across functions to support...$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...- ...Summary Reporting to the Chief Regulatory Officer, the Sr Director of Regulatory Affairs will join the regulatory team... ...have a strong understanding of CMC considerations for biologics and... ...the project teams and Company management. Ensure alignment of regulatory...SeniorLocal area
Rezolute
Redwood City, CA13 days ago $143.23k - $185.35k
...Senior Manager of Regulatory Affairs at Kite responsible for developing regulatory strategies, leading submissions to health authorities (FDA, EMA, others), and managing cross-functional teams for oncology drug development programs. Based in California with flexible work...SeniorFlexible hours$258k - $320k
...Primary Function: Responsible for leading the global CMC regulatory strategy and execution for both small molecule and biological... ...regulations and guidelines (ICH, NMPA, FDA, EMA, etc.). Lead and manage a team of CMC regulatory professionals, including mentoring, performance...SeniorWork at officeWorldwideRelocation package$250k - $300k
...Position Summary: The Senior Director, Regulatory Affairs is Orca Bio's functional Head of... ...approval regulatory operations and lifecycle management, while also maintaining regulatory... ...programs, new indications, global expansion, CMC Regulatory and other significant...SeniorFull timeLocal areaImmediate startRemote workOrca-Bio
Menlo Park, CA9 hours ago$302.01k - $390.83k
...Gilead seeks a Head of CMC Regulatory Affairs for small molecules to lead global chemistry, manufacturing, and controls strategies across the... ...regulatory plans from clinical through commercialization, managing submissions and approvals Ensure regulatory conformance...- ...ImmunEdge is seeking an experienced Regulatory Affairs leader to develop and execute global regulatory... ..., Research, Translational Medicine, CMC, Nonclinical, Quality,... ...development through registration and lifecycle management. ~ Ensure regulatory strategy is integrated...SeniorFull timeWork at officeLocal area
ImmunEdge, Inc
Redwood City, CA5 days ago $180k - $195k
...members, regardless of level, to understand challenges and drive results. About The Role Reporting to the Director, Regulatory Affairs, the Senior Manager, Regulatory Affairs leads regulatory support for assigned programs to ensure sound regulatory planning and tactical...SeniorFull timeFor contractorsLocal area3 days per week$130k - $179k
...patients. For more information, please visit our website at Manager, Regulatory Affairs Adicet Bio is seeking a highly motivated Manager,... ...They will be primarily responsible for managing the global CMC regulatory implementation of assigned projects in early to...Full timeTemporary workWork at officeFlexible hours3 days per weekInitial Therapeutics, Inc.
Redwood City, CA1 day ago- ...clinical supplies that are compliant with global regulatory requirements and standards are delivered to patients. The Senior Manager, Clinical Product Supply is primarily... ...interdisciplinary product development teams (e.g., CMC teams), the Senior Manager is responsible for...SeniorFull timeTemporary workLocal areaWorldwide
AbbVie Inc.
South San Francisco, CAmore than 2 months ago $226.19k - $292.71k
...pratices related to interactions between commercial, medical affairs and market access. Invest time and effort in building strong... ...Ideally the majority of the years of career spent in-house. ~ Management experience and ability to mentor and supervise a team of...SeniorFull timeFor contractorsLocal areaGilead Sciences
Foster, CAa month ago$324.62k - $420.09k
...patients.RWE is increasingly informing regulatory decisions across development and the product... ...and their teams, Global Regulatory Affairs, Biostatistics, Clinical Development, Clinical... ...team.· Experience evaluating or managing external data, research or service partners...Full timeFor contractorsLocal areaImmediate startShift workGILEAD Sciences
San Mateo, CA4 days ago$169.32k - $219.12k
...team helps accelerate discovery, improve organizational effectiveness, and strengthen the impact of Research.Position SummaryThe Sr. Manager, Research Strategic Projects serves as a trusted partner to leaders across Research, leading cross-functional initiatives that strengthen...SeniorFull timeFor contractorsWork at officeLocal areaGILEAD Sciences
Foster, CA1 day ago$126.82k - $164.12k
...and Process Development, as an Sr. Associate Scientist. The... ...documents such as protocols, reports, regulatory dossier, etc. and prepare data... ...before discussing with manager or supervisor.Support or represent... ...experience in biologics CMC development. Hands-on laboratory...SeniorFull timeFor contractorsLocal areaGILEAD Sciences
Foster, CA4 days ago$270k - $295k
...and highly motivated Senior Director of Regulatory Affairs to lead regulatory strategy and execution... ...to health authority inquiries. Manage interactions with FDA and other global regulatory... ...regulatory meetings. Partner with CMC, Nonclinical, and Clinical teams to...SeniorFull time- Freshworks is seeking a Senior Director of People Analytics & Workforce Planning in San Mateo, CA. This hybrid role leads the People Analytics function, defines strategy and governance, and partners with HR and business leaders to enable data-driven decisions. You will...Senior
$22.3 per hour
...access to discounts through Associate Perks \n \n \n Now, about you: \n \n Are comfortable interacting with customers and management in a friendly, enthusiastic, and outgoing manner \n Are 18 years or older \n Available 4+ days a week including Sunday &...SeniorHourly payPart timeShift workCDS (Club Demonstration Services)
San Mateo, CA20 days ago- ...visit us at . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube. Job Description The Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada (Hybrid) is responsible for the development and implementation of US and Canada...SeniorFull timeLocal area
- Shield AI is seeking a highly experienced software professional to join the Special Projects team under the Office of the CTO. This elite group blends aerospace, robotics, cloud, and frontend expertise to steer Hivemind technology development and deliver rapid, forward...SeniorWork at office
$167.88k - $178.5k
...Follow @abbvie on X , Facebook , Instagram , YouTube , LinkedIn and Tik Tok . Job Description Senior Scientist II – CMC Developmental Sciences, AbbVie Biotherapeutics Inc., South San Francisco, CA (100% onsite). Key Responsibilities • Perform on...SeniorFull timeTemporary workWork experience placementAbbVie Inc.
South San Francisco, CAmore than 2 months ago- ...CBRE is seeking a highly motivated and results-driven Senior Project Manager to lead the delivery of complex construction and renovation projects from initiation through closeout. This role requires strong technical expertise, exceptional client service skills, and the...SeniorContract workFor contractorsFor subcontractor
CBRE Group, Inc.
San Mateo, CA2 days ago - ...YouTube. Job Description The Biologics CMC Development team at AbbVie in the Bay... ...team of highly experienced scientists and managers who have directly enabled the development... ...reviewing peer-reviewed literature, regulatory guidance, patents, and emerging industry...SeniorFull timeContract workLocal area
AbbVie Inc.
South San Francisco, CA5 days ago - ...Summary Delta Star Inc. is seeking a skilled and innovative Sr. Electrical Design Engineer to design and engineer medium voltage... ...Excellent communication and collaboration abilities. Proven ability to manage multiple tasks and meet deadlines effectively. #J-18808-LjbffrSeniorRelocationRelocation package
Clear Destination
San Carlos, CA1 day ago $150k - $170k
...autoimmune disease. Led by a management team with significant experience... ...Technology, Clinical, Regulatory, and other development functions... ...management with an emphasis on CMC knowledge and the ability to... ...Clinical Operations, and Regulatory Affairs. * Develop, maintain, and...SeniorFull timeWork at officeLocal areaRemote workAllogene Therapeutics
South San Francisco, CAmore than 2 months ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Sr Manager, Regulatory Affairs CMC. Be the first to apply!
Related searches
- senior software engineer ruby on rails Foster, CA
- senior compensation manager Foster, CA
- senior cloud data engineer Foster, CA
- senior manager Foster, CA
- senior living Foster, CA
- senior vmware engineer Foster, CA
- senior consulting engineer Foster, CA
- senior sas developer Foster, CA
- remote senior project manager Foster, CA
- senior director program management Foster, CA