Senior Regulatory Strategy Manager - Hematology/Oncology
Initial Therapeutics, Inc.
Nurix Therapeutics, a clinical-stage biopharmaceutical company, seeks a Senior Manager / Associate Director of Regulatory Affairs (Strategy, Hematology Oncology) to lead regulatory strategy for global programs from Brisbane, CA, onsite. You will build and execute regulatory plans, oversee submissions, and ensure lifecycle management in collaboration with cross-functional teams. The role requires 8+ years in regulatory affairs with strong knowledge of FDA/EMA/ICH guidelines, and a proven track #J-18808-Ljbffr Initial Therapeutics, Inc.
- Senior Manager/Associate Director, Regulatory Affairs (Strategy, Hematology Oncology) Brisbane, California, United States Senior Manager / Associate Director, Regulatory Affairs (Strategy, Hematology Oncology) Nurix Therapeutics is a clinical stage biopharmaceutical company...SeniorFor contractors
- ...Therapeutics, Inc. invites an experienced Director/Senior Director of Regulatory Affairs (Strategy, Oncology - Solid Tumors) to join the Regulatory team. You... ...enable timely regulatory approvals and life cycle management. This onsite Brisbane, CA role reports to the SVP,...Senior
$232k - $274k
...seeking a Director/ Sr. Director, Regulatory Affairs (Strategy, Oncology - Solid Tumors) to join the Regulatory... ...of registration and life cycle management activities. This position works cross... ...Salary Range: Director: $232K - $274K Senior Director:$279K - $331K Location:...SeniorFor contractorsWorldwide- IDEAYA Biosciences is seeking a Senior Director, Project Management to lead the IDE892 program, providing... ...leadership across a high-priority oncology development program. The role demands... ...collaboration with Clinical Operations, Regulatory, and external #J-18808-Ljbffr...Senior
- Scorpion Therapeutics seeks a senior Quantitative Systems Pharmacology (QSP) leader to define modeling strategy across oncology programs. You will mentor quantitative... ...external partnerships, manage budget/planning, and ensure regulatory-grade deliverables for IND/NDA...Senior
$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... ...aspirations and update senior management on project risks/mitigation activities...SeniorHourly payTemporary workWorldwideFlexible hours3 days per week$258k - $320k
...bringing transformative medicines for oncology, autoimmune disorders, infectious diseases... ...Responsible for leading the global CMC regulatory strategy and execution for both small molecule... ...ICH, NMPA, FDA, EMA, etc.). Lead and manage a team of CMC regulatory professionals,...SeniorWork at officeWorldwideRelocation package- ...several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our... ..., Instagram, X and YouTube. Job Description The Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada (Hybrid) is responsible for the development...SeniorLocal area
- ..., based in South San Francisco, is seeking a Senior Director, Project Management to lead IDE892, a high-priority oncology program spanning early to registrational development... ...strategic leadership across scientific, regulatory, and clinical teams in a highly matrixed...Senior
- Genentech is seeking a Senior Patient Experience Business Partner (Sr. PXBP) to lead patient experience strategies for high-complexity Therapeutic Areas. You will embed within PX squads, translate TA strategies into PX roadmaps, and partner with Access to integrate barriers...Senior
- Nurix Therapeutics in Brisbane, CA seeks a Senior Manager/Associate Director of Regulatory Affairs (Strategy, Hematology Oncology) to lead global regulatory strategy and programs for development and future marketing of oncology products. You will design regulatory strategies...Senior
- Genentech is seeking a senior leader to guide Immunology Research in South San Francisco. The VP will shape strategy, foster an innovative, rigorous environment, and drive cross... ...programs spanning neuroscience, oncology, CVRM, ophthalmology and infectious diseases...Senior
- 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...Senior
- 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,...Senior
- 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...SeniorFull 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 candidate will lead CMC strategy, manage regulatory interactions, and build a...SeniorWork at office2 days per week
- Kardigan in Princeton, NJ is seeking a Senior Director, Clinical Pharmacology to lead strategies across cardiovascular development and regulatory interactions with FDA and global health authorities. You will drive dose selection, exposure‑response analyses, PK/PD modeling...Senior
- ...leadership across hematology (multiple studies... ...to disease area strategy using expertise in... .... Provide senior scientific guidance... ...partners (Clinical Ops, Regulatory, Biostats/Data... ...years hematological oncology drug development,... .../study & trial management; Hematology;...Senior
- Nurix Therapeutics is seeking an experienced Senior Director, Quality Control to join the Analytical Development and... ...will bring deep small-molecule QC expertise, strong regulatory acumen, and a track record managing external CDMO and CTL partnerships, with responsibility...Senior
$250k
...Permanente San Francisco, including Cardiology, Gastroenterology, Hematology/Oncology, and Nephrology, as well as non-ACGME one-year fellowships... ...medical record system that allows flexibility in patient management. Work-life balance focused practice, including flexible...Full timeFor contractorsInternshipLocal areaFlexible hours$240k - $300k
...Description The Director or Senior Director, Clinical... ...development, regulatory interactions, and data... ...cell therapy trials in oncology. Contribute meaningfully... ...; contribute to risk management strategies. Ensure ethical... ...prior) in oncology, hematology, or a related field...SeniorLocal area$175k - $205k
Erascais a clinical-stage precision oncology company focused on discovering,... ...Reporting to the Executive Director, CMC Regulatory Affairs, the Senior Manager or Associate Director of CMC... ...appropriate global regulatory filing strategies. Collaborate cross-functionally on...SeniorTemporary workCasual workLocal areaWorldwideFlexible hours- IDEAYA Biosciences, Inc. is seeking a Senior Director, Project Management to lead IDE892, a high-priority, multi-arm oncology program, providing strategic and operational leadership from development through potential registrational studies. The role requires on-site presence...Senior
- ...in South San Francisco is seeking a Senior Director, Project Management to lead the IDE892 program,... ...operational leadership across a multi-arm oncology development effort. This highly matrixed... ...integrating scientific, clinical, regulatory, and commercial perspectives with...Senior
- Genentech is seeking a Senior Strategy Manager to lead access and contracting strategy across our portfolio for payer, PBM, and specialty segments. You will partner with Customer Engagement, Pricing, Legal, and cross-functional squads to shape high-impact access solutions...SeniorRemote job
$292k - $409k
Senior Medical Director, Oncology Clinical Development Full-time Zai Lab... ...executing on the clinical strategy, serving as Medical... ..., supporting regulatory submissions and... ...advancement. Lifecycle Management: Develop strategies... ...in Oncology, Hematology-Oncology, or a related...SeniorFull timeWork at officeWorldwideRelocation package$206.5k - $393k
Senior Scientific Director, Oncology Clinical Development (Non-Hodgkin Lymphoma) Full-... ...scientific and business strategy. Responsibilities Leads... ...knowledge of compliance and regulatory requirements, AbbVie’s... ....g., MS, PhD) preferred. Hematology experience preferred. Non...SeniorFull timeTemporary workLocal area$190.8k - $300.3k
...Description The Senior Director, Clinical Science - Hematology is responsible for... ...- Hematology, Oncology Assets and Early Development... ...to disease area strategy by applying deep... ...for direct management and development of... ...Clinical Operations, Regulatory Affairs, Biostatistics...SeniorFull timeFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work- ...areas including immunology, oncology and neuroscience - and products... ...Purpose: The Sr Manager Process Excellence Lead (PEL)... ...and deliver on organizational strategies, goals, and objectives. They... ...leadership, function heads and senior leadership for alignment and...SeniorFull timeLocal area
- ...Senior Medical Director, Clinical Development (Medical Monitoring) About the Company Rapidly growing organization in the oncology & hematology industry Industry Hospital & Health Care Type Privately Held About the Role The Company is seeking a Senior...Senior
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