CMC Regulatory Strategy Director, Gene & Cell Therapy
Sentibio
Sentibio in South San Francisco seeks a regulatory affairs leader to drive CMC strategies for a complex cell therapy program. You will shape global regulatory CMC plans, coordinate type B/C/D meetings, and ensure alignment with agency expectations across the organization. The role requires a BA/BS in a scientific field and 10+ years in regulatory, with extensive experience in biologics and gene/cell therapy. Some travel (approx. 20%) is expected, and VP-level reporting possibilities may exist. #J-18808-Ljbffr Sentibio
Vacancy posted 3 days ago
Similar jobs that could be interesting for youBased on the CMC Regulatory Strategy Director, Gene & Cell Therapy in South San Francisco, CA vacancy
$218.06k - $327.09k
...Job Description The Senior Director, Oncology Cell and Gene Therapy Regulatory Affairs, leads the development and implementation... ...of the global regulatory strategy for CGT products of high... ...the regions, emerging markets, RA CMC, Labeling and members of the submission...SuggestedHourly payTemporary workWorldwideFlexible hours3 days per weekSouth San Francisco, CA4 days ago- Zai Lab Limited seeks a senior CMC regulatory leader to drive global regulatory strategy for both small molecules and biologics from its South San Francisco office. You will oversee IND/CTA and NDA/BLA submissions, coordinate with health authorities, and guide cross-functional...SuggestedWork at office
- ...Principal Scientist to lead the Bioanalytical Strategy for Cell Therapy. You will define integrated data... ...questions and inform development, regulatory, and portfolio decisions across programs... ...Translational Medicine, Clinical Development, CMC, Regulatory, and Computational...Suggested
$245k - $285k
...for leading and managing the regulatory affairs within CMC function. This includes developing... ...and leading regulatory CMC strategies and activities for a complex cell therapy product on a global basis. The... ...phase-appropriate compliance of gene and cell therapy pipeline of...SuggestedContract work- ...growing pipeline of first-in-class therapies to address genetically... ...are seeking a motivated Senior Director, Regulatory Chemistry, Manufacturing, and Controls (CMC) to be responsible for the development of regulatory strategies and submissions related to the manufacturing...SuggestedFull timeWork at office2 days per week
$210k - $260k
Using living cells to treat - and sometimes... ...with cell therapies. However, these profound... ...CA offices. The Director of Regulatory Affairs/Global... ...global regulatory strategy for assigned CAR‑... ...requirements, CMC, and clinical development... ...in the cell and gene therapy field....Temporary workLocal area- Marea Therapeutics, Inc. is seeking a Senior Director, Regulatory Chemistry, Manufacturing, and Controls (CMC) to lead regulatory strategies and submissions for US and global manufacturing programs. This role reports to the Executive Director of Regulatory Affairs and requires...Full time
- Marea Therapeutics is seeking a Senior Director, Regulatory Chemistry, Manufacturing, and Controls (CMC) to shape regulatory strategies for manufacturing across the US and global markets. The role reports to the Executive Director of Regulatory Affairs and will own CMC...Work at office2 days per week
- Kardigan, Inc. seeks a Senior Director, CMC Regulatory to lead regulatory activities for late-stage cardiovascular assets. You will define and execute CMC strategies, interact with global health authorities, and ensure timely, compliant submissions across programs. The...
- Kardigan seeks a Senior Director, CMC Regulatory to lead the development and execution of CMC regulatory strategies driving global submissions and interactions with health authorities. This role reports to the Head of CMC Regulatory and is based in South San Francisco,...
$157.59k - $203.94k
...cancer - working relentlessly to develop therapies that help improve lives and to ensure... ...DescriptionJOB DESCRIPTIONThe Senior Manager, CMC Regulatory Affairs - Combination Products and... ...implementation of global regulatory strategy and is accountable for execution of high...Full timeFor contractorsLocal areaGILEAD Sciences
Foster, CA23 days ago- AbbVie is seeking an Associate Director Regulatory Affairs, CMC to lead regulatory strategies and submissions for complex products. You will collaborate with R&D, Operations and Global Regulatory teams to enable first-pass approvals and ensure compliant content for INDs...
$159k - $207k
## Associate Director, CMC Program MgmtApplylocations: South San Franciscotime type: Full timeposted... ...dedicated to developing breakthrough therapies for neurodegenerative diseases through... ...for organizing and managing CMC strategies, deliverables, and timelines for Denali...Contract workLocal area- Denali Therapeutics, located in South San Francisco, is looking for an experienced professional to develop regulatory strategies for complex programs. The role requires 10+ years of experience in regulatory affairs, leadership in cross-functional teams, and expertise in...
$258k - $320k
...portfolio of potential best-in-class and/or first-in-class therapies. Zai currently has four products on the market in China... ...Primary Function: Responsible for leading the global CMC regulatory strategy and execution for both small molecule and biological projects...Work at officeWorldwideRelocation packageZai Lab (US) LLC
South San Francisco, CA22 days ago- ...South San Francisco, CA, seeks an Associate Director/Director, Clinical Development Program Management... ...requires extensive biopharma experience, cell therapy or oncology focus, and the ability to translate clinical strategy into actionable plans. #J-18808-Ljbffr Lyell...
- Marea Therapeutics in South San Francisco is seeking a Senior Director, Regulatory Chemistry, Manufacturing, and Controls (CMC) to lead regulatory strategies for manufacturing products in the US and globally. The role reports to the Executive Director, Regulatory Affairs...Full time
$248k - $310k
...make a real difference, every day. Position Title: Senior Director, CMC Regulatory Department: Regulatory Affairs Reports To : Head of CMC... ...motivated individual who will help define CMC Regulatory strategies and successfully execute them in submissions and health authority...$157.59k - $203.94k
...cancer – working relentlessly to develop therapies that help improve lives and to ensure... ...JOB DESCRIPTION The Senior Manager, CMC Regulatory Affairs – Combination Products and Device... ...implementation of global regulatory strategy and is accountable for execution of high...Full timeFor contractorsLocal area- Erasca is seeking a Sr Manager/Assoc Director, CMC Regulatory Affairs to lead regulatory activities for IND/CTA development and ongoing trials. The role involves preparing CMC documents, ensuring regulatory compliance, and coordinating global submissions. The ideal candidate...Remote job
- Marea Therapeutics seeks a Senior Director, Regulatory Chemistry, Manufacturing, and Controls (CMC) to lead regulatory strategies and submissions for the manufacturing of our products in the US and globally. The incumbent will oversee Regulatory CMC aspects of product development...
- ...infiltrating lymphocyte (TIL) therapy for people with cancer. We are... ...recognize and attack diverse cancer cells in each patient. The Iovance... ...in cell therapy, including gene‑edited cell therapy, which may... .... Overview The Manager, Regulatory Affairs, represents Regulatory...Work at officeRemote work
- ...Executive Director, Regulatory Affairs About the Company Esteemed company... ...Specialties cell therapy autoimmune and lupus... ...executing global regulatory strategy to support the development,... ...Experience in cell and/or gene therapy, particularly in the...
$324.62k - $420.09k
...- working relentlessly to develop therapies that help improve lives and to ensure... ....RWE is increasingly informing regulatory decisions across development and the... ...World Evidence (EpiRWE), the Executive Director, Regulatory RWE Strategy and Innovation is a scientific and...Full timeFor contractorsLocal areaImmediate startShift workGILEAD Sciences
Foster, CA2 days ago$135k - $175k
...dedicated to developing breakthrough therapies for neurodegenerative diseases... ...management is a cornerstone of Denali’s strategy. The Clinical Supply Chain Planner will... ...therefore interfaces heavily with CMC, Manufacturing, QA, Regulatory, Clinical Operations, and Finance. As...Work experience placementLocal area- Calico Life Sciences is looking for a Regulatory Director in South San Francisco to develop and implement innovative regulatory strategies, ensuring compliance with health authority guidelines. The role requires collaboration with various teams, overseeing regulatory submissions...
- Enigma Search is looking for a Director of Regulatory Affairs to spearhead regulatory strategies in South San Francisco. The ideal candidate will possess a Master... ...includes developing strategies for first-in-class therapies and ensuring clear communication with global...
- Denali Therapeutics Inc. seeks a Director of Patient Support Strategy & Operations to build and scale patient support and access capabilities for upcoming... ...support pathways to ensure smooth onboarding and therapy initiation at a high quality. The role requires strategic...
- ...Therapeutics is seeking an experienced Senior Director, Quality Control to join the Analytical... ..., and a team to support programs from CMC development through commercial manufacturing... ...deep small-molecule QC expertise, strong regulatory acumen, and a track record managing...
$190k - $230k
Associate Director, Clinical Development Program Management Using living cells to treat - and sometimes even... ...successfully treated with cell therapies. However, these... ...Development, CMC, Regulatory Affairs, Biometrics,... ...translates clinical strategy into actionable operational...Local area
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to CMC Regulatory Strategy Director, Gene & Cell Therapy. Be the first to apply!
Related searches
- senior regulatory manager South San Francisco, CA
- training and compliance manager South San Francisco, CA
- director global regulatory affairs South San Francisco, CA
- compliance manager South San Francisco, CA
- manager regulatory affairs South San Francisco, CA
- regulatory affairs manager pharmaceutical South San Francisco, CA
- senior director regulatory affairs South San Francisco, CA
- regulatory manager South San Francisco, CA
- sr. manager regulatory compliance South San Francisco, CA
- regulatory cmc manager South San Francisco, CA