Senior Regulatory CMC Strategist Cell Therapy Leader
Bayer (Schweiz) AG
Bayer (Schweiz) AG is seeking a Senior Regulatory CMC Strategist (Senior Director) to lead global CMC strategies for cell therapy programs and manage regulatory submissions across US and international authorities.
The role requires an advanced scientific degree, deep regulatory CMC experience in biologics or cell therapy, and strong leadership skills to mentor teams and coordinate with multiple departments. Up to 20% travel is expected.
#J-18808-LjbffrVacancy posted 1 day ago
Similar jobs that could be interesting for youBased on the Senior Regulatory CMC Strategist Cell Therapy Leader in Berkeley, CA vacancy
$218.8k - $328.3k
...become your best, you'll find it here.Senior Regulatory CMC Strategist (Senior Director) The Senior... ...and guidance to CMC teams developing cell and gene therapy products. The position also serves as the Regulatory CMC Leader for advanced cell therapy products; leads...SeniorRegulatoryFor contractorsLocal areaShift workBayer
Berkeley, CA3 days ago- ...The Clorox Company is seeking a senior Regulatory expert who will lead regulatory strategy, readiness, and compliance across multiple programs, including EPR, packaging, and labeling. You will translate complex regulations into actionable plans and collaborate with stakeholders...SeniorRegulatory
The Clorox Company
Oakland, CA3 days ago $218.06k - $327.09k
Job Title: Senior Director, Oncology Cell and Gene Therapy Regulatory AffairsLocation: South San Francisco -CA, USA, or Gaithersburg... ...next generation of regulatory leaders. Your work will directly... ...the regions, emerging markets, RA CMC, Labeling and members of the submission...SeniorRegulatoryHourly payFull timeTemporary workWorldwideFlexible hours3 days per weekAstraZeneca
San Francisco, CA7 days ago- ...Spectraforce Technologies, Oakland, seeks a Senior Compliance Consultant to support policy scanning, requirements management, and strategic... .... This role requires a Bachelor's degree and 3–5 years in regulatory, compliance, or analytics, with strong research, writing, and...SeniorRegulatory
Spectraforce Technologies
Oakland, CA2 days ago - ...Electrical Engineer to own the electrical architecture of PAP therapy systems. You will design, verify, and produce electronics, manage... ...across systems, firmware, mechanical, software, QA, regulatory, suppliers, and CMOs to deliver reliable medical electronics from...SeniorRegulatory
SleepRes™, Inc.
San Francisco, CA1 day ago $170k - $185k
...A biotechnology company focused on vision restoration therapies seeks a Senior Manager, Regulatory Affairs in Berkeley, CA. This role involves developing regulatory strategies for clinical-stage programs and managing interactions with agencies like the FDA. The ideal...SeniorRegulatoryRay Therapeutics, Inc.
Berkeley, CA2 days ago$170k - $185k
Job/Role Title: Senior Manager, Regulatory Affairs Reporting to: Chief Regulatory Officer Ray Therapeutics... ...best-in-class vision restoration therapies for people with degenerative retinal diseases... ...collaborating closely with Clinical, CMC, Nonclinical, and Quality teams...SeniorRegulatoryWork at office2 days per week$175k - $205k
...Senior Clinical Data Manager Headquarters Location... ...safer, more effective therapies is driven by our... ...conjugates ("ADCs"), T-cell engagers, and immune modulators... ..., safety evaluations, regulatory deliverables,... ...recommendations to senior leaders. Experience...SeniorRegulatoryContract workCytomX Therapeutics
Emeryville, CA4 days ago- ...Nektar Therapeutics is seeking a Senior Director of Marketing to help build the commercial foundation for REZPEG, our Treg therapy, with lead responsibility for alopecia areata... ...Strong cross-functional leadership and regulatory fluency are essential. #J-18808-Ljbffr...SeniorRegulatory
Nektar Therapeutics
San Francisco, CA1 day ago $150k - $165k
...development of groundbreaking therapies. Our mission is to be... ...possible.The Senior Program Manager, Plasmid... ...Performance Qualification (PPQ), regulatory readiness, and... ...client-facing program leader for assigned programs and... ...manufacturing and its use in cell and gene therapy, gene...SeniorRegulatoryFull timeRemote workWork from homeFlexible hoursNight shiftDanaher Corporation
San Francisco, CA8 days ago$340k
...deliver medically-differentiated therapies that provide meaningful improvement to patients. The Senior Group Medical Director leads... ...-most expert within PDC, this leader holds ultimate accountability... ...Medical Affairs, Commercial, Regulatory and Pharma Partnering senior leaders...SeniorRegulatoryLocal areaRelocation packageGenentech
San Francisco, CA3 days ago- ...Sila in Alameda, CA is seeking a Staff Engineer to lead cell manufacturing design, focusing on cylindrical cell equipment and line... ...manufacturing, and battery engineering to advance state-of-the-art cells, while ensuring safety and regulatory compliance. #J-18808-LjbffrSeniorRegulatory
Sila
Alameda, CA2 days ago - ...Mercor in San Francisco is seeking senior wealth management and asset management professionals to build evaluation tasks for AI systems... ...investment professionals think, with emphasis on fiduciary and regulatory standards. The role demands deep portfolio ownership and...SeniorRegulatory
Mercor Inc
San Francisco, CA3 days ago - ...deliver IFC‑compliant ESIA work for international initiatives, and mentor staff while expanding ERM’s transportation practice. The role emphasizes global sustainability, regulatory alignment, and business development to grow a best‑in‑class practice across #J-18808-Ljbffr...SeniorRegulatory
Erm LLC
Walnut Creek, CA2 days ago - ...Senior Director, Clinical Operations Lead the execution of groundbreaking... ...and help advance innovative therapies for patients with unmet... ...for a clinical operations leader who thrives in a fast-paced... ...ICH‑GCP and applicable global regulatory requirements. Maintain inspection...SeniorRegulatory
Real Staffing Group
Oakland, CA15 hours ago $120k - $130k
...is seeking a compassionate and skilled Senior Licensed Marriage and Family Therapist (... ...professionals specializes in a range of therapies tailored to meet the unique needs of our... ...confidential client records in compliance with regulatory standards, ensuring alignment with best...SeniorRegulatoryRemote jobFull timeFlexible hoursInner Peace Psychotherapy, LLC
Oakland, CA23 days ago- ...Citigroup Inc. in San Francisco, CA seeks a Senior Client Service Manager to lead a team delivering exceptional banking and investment... ...with banking partners to resolve issues while ensuring regulatory compliance. The role emphasizes onboarding, KYC/AML, risk governance...SeniorRegulatory
Citigroup Inc
San Francisco, CA2 hours ago - BridgeBio Inc. in San Francisco seeks a Senior Manager, Project Management to join the CMC team, ensuring cross-functional planning, risk mitigation, and resource... .... You will interface with multiple CDMOs, support regulatory filing drafting, and help manage budgets and...SeniorRegulatory
- ...Finezi Inc. seeks a senior compliance program leader to guide the development, monitoring, and continuous improvement of its regulatory framework across Electric Compliance sub-functions and partner teams. You will translate complex regulatory requirements into actionable...SeniorRegulatory
Finezi
Oakland, CA2 hours ago $93.84k - $140.76k
...real difference, there’s only one choice. Sr Prod Spec Cell Therapy Cell Culture - Berkeley, CA As a Sr. Product Specialist... ...corrective and preventive actions; As SME, lead and participate in regulatory and internal audits, including preparing and delivering...SeniorRegulatoryLocal areaFlexible hoursShift work- ...PayJoy, Inc. is seeking a Senior Corporate Counsel to serve as a strategic partner to our Finance and Capital Markets teams and the... ...governance, handling high-stakes transactions, and managing external regulatory documentation to support PayJoy's growth trajectory. The ideal...SeniorRegulatory
PayJoy
San Francisco, CA3 hours ago $285k - $400k
...environment. This role requires a leader who is both a strategic... ...product profile, the clinical and regulatory path to registration, and the... ...clinical development, regulatory, CMC development and GMP... ...Additional experience in gene therapy, gene editing, or another advanced...RegulatoryFull timeLocal areaMetagenomi
Emeryville, CA3 days ago- ...Genentech, located in South San Francisco, seeks a Senior Principal Scientist in Translational Safety to provide scientific leadership... ...cross-functional teams, design safety programs, mentor scientists, and contribute to regulatory strategy and external #J-18808-LjbffrSeniorRegulatory
Genentech
San Francisco, CA2 days ago - ...finance, and product teams. You will shape policy, oversee screening and enforcement controls, and partner with counsel to navigate regulatory expectations. This role requires strong leadership, deep knowledge of OFAC/EAR rules, and a track record of delivering risk-...SeniorRegulatory
Anthropic
San Francisco, CA1 hour ago - ...AbbVie is seeking an experienced leader to oversee direction, planning and interpretation of clinical trials within one or more development... ...generate high-quality data that informs product strategy and regulatory submissions. The role requires extensive clinical trial...SeniorRegulatory
AbbVie
San Francisco, CA1 day ago - ...BayOne Solutions is seeking a senior-level compliance program leader to guide the development, implementation, monitoring, and continuous improvement... ...controls, and develop metrics, templates, and training materials to strengthen regulatory alignment and risk #J-18808-Ljbffr...SeniorRegulatory
BayOne Solutions
Oakland, CA1 day ago $260k - $285k
...approach to developing better therapies and passionate colleagues... .... ABOUT THE ROLE The Senior Director, Commercial Manufacturing... ...is Olema’s senior leader accountable for building,... ...manufacturing, partnering with CMC Technical, Quality and Regulatory on registrational...SeniorRegulatoryFlexible hoursOlema Oncology
San Francisco, CA5 days ago- ...Glint Tech Solutions seeks a Senior Product Manager – Molecular Diagnostics to lead product strategy, development, and commercialization... ...customers, KOLs, R&D, manufacturing, supply chain, and quality/regulatory teams to translate market needs into product requirements,...SeniorRegulatory
Glint Tech Solutions
San Francisco, CA3 days ago - Menlo Ventures is seeking a Senior Customer Experience Strategy leader in San Francisco to guide the development of CX plans aligned with strategic goals. You will analyze customer feedback and market insights to surface opportunities and shape initiatives across product...Senior
- ...LaunchDarkly seeks a Senior Benefits Manager to own the health, wellness, and financial benefits programs for a distributed workforce... ...will lead strategy, manage carrier/vendor relationships, ensure regulatory compliance, and partner with executives to optimize cost and...SeniorRegulatory
LaunchDarkly Group
Oakland, CA3 days ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior Regulatory CMC Strategist Cell Therapy Leader. Be the first to apply!
Related searches
- senior brand strategist Berkeley, CA
- key team leader Berkeley, CA
- quality control team lead Berkeley, CA
- IT team lead Berkeley, CA
- site leader Berkeley, CA
- leader Berkeley, CA
- focus group leader Berkeley, CA
- merchandise team leader Berkeley, CA
- office team lead Berkeley, CA
- operational excellence leader Berkeley, CA