Director, REMS Regulatory Strategy & Compliance
$263.88k - $307.86kCytokinetics
Cytokinetics is seeking a Senior Director for Regulatory Affairs in South San Francisco. This role involves leading regulatory strategies related to Risk Evaluation and Mitigation Strategies (REMS), ensuring compliance, and managing cross-functional teams. The ideal candidate has over 10 years of experience in the pharmaceutical sector, with a strong background in REMS operations and strategy. The position offers a competitive salary range of $263,880 to $307,860 per year. #J-18808-Ljbffr Cytokinetics
$263.88k - $307.86k
## Senior Director, Regulatory Affairs REMS ProgramApplylocations: South San Francisco, Californiatime type... ...responsible for leading regulatory strategy and execution related to Risk Evaluation... ...(REMS) and providing regulatory compliance oversight for REMS.# **Responsibilities...SuggestedFor contractors- Nurix Therapeutics, Inc. invites an experienced Director/Senior Director of Regulatory Affairs (Strategy, Oncology - Solid Tumors) to join the Regulatory team. You will develop and execute the global regulatory strategy, guide high-quality submissions, and work with cross...Suggested
- 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...Suggested
$232k - $274k
Job Summary: Nurix Therapeutics, Inc. is seeking a Director/ Sr. Director, Regulatory Affairs (Strategy, Oncology - Solid Tumors) to join the Regulatory team. The successful candidate will be a core member of the Regulatory team working in close collaboration with the...SuggestedFor contractorsWorldwide- 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...SuggestedWork at office2 days per week
- Nurix Therapeutics, based in Brisbane, CA, seeks a Director, Regulatory Affairs (Strategy, I&I) to lead global regulatory strategy for immunology and inflammation programs. The role requires coordinating with internal teams and Health Authorities to enable timely regulatory...
- Zipline seeks a Director of Airspace Policy and Regulatory Affairs to shape how autonomous delivery integrates into global airspace. You will define policy strategy, engage with regulators, standards bodies, and industry peers, and translate regulatory changes into practical...
- 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...
- 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,...
- 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
$220k - $254k
Director, Regulatory Affairs (Strategy, I&I) Brisbane, California, United States Director, Regulatory Affairs - Strategy, Autoimmune Disease (AID) Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization...For contractorsWork at office- 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...
$103k - $138k
...Responsibilities JOB PURPOSEThe Manager, Environmental Compliance & Strategy, EPC is responsible for ensuring environmental compliance and... ...with internal project teams, consultants, contractors, regulatory authorities, and local interest groups to ensure Pattern’s...Full timeTemporary workFor contractorsWork experience placementLocal area$324.62k - $420.09k
...patients.RWE is increasingly informing regulatory decisions across development and... ...Evidence (EpiRWE), the Executive Director, Regulatory RWE Strategy and Innovation is a scientific and... ...the scientific rigor, quality and compliance expected by global health authorities...Full timeFor contractorsLocal areaImmediate startShift work- ...leading biotechnology company in South San Francisco seeks a Director of Clinical Regulatory to oversee multiple clinical drug candidates and drive... ..., leading project teams, and developing regulatory strategies. An ideal candidate will have at least 10 years of experience...
$275k - $280k
...breakthroughs. Position Description: Calico is seeking a Regulatory Director that will be responsible for, in collaboration... ...and implementing innovative regulatory strategies to support development programs, in compliance with health authority guidelines and regulations...Full time- 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...
- 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...Work at office
$258k - $320k
...Primary Function: Responsible for leading the global CMC regulatory strategy and execution for both small molecule and biological projects... ...scientific soundness, data integrity, and regulatory compliance across all product modalities. Develop and implement comprehensive...Work at officeWorldwideRelocation package- ...Job Description The Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada (Hybrid) is responsible... ...Global Regulatory Lead (GRL), Associate Director, or Director), in the development &... ...-functional areas. Operates in compliance with regulations, company policies,...Local 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...
$209.7k - $389.4k
...valuable part of our Contract Strategy Implementation (CSI) team... ...drives operational excellence, compliance, and sustainable business... ...strategies.The OpportunityThe Sr. Director, Contract Strategy... ...access models, and government/regulatory contracting guidelines.Operational...Full timeContract workLocal areaRelocation package- ...clinical trials within one or more development programs. You will lead cross-functional teams, ensure regulatory compliance, and contribute to translational strategies in partnership with Discovery and Medical Affairs. The role requires MD/DO with 2+ years of clinical trial...
- ...strategic plans for clinical programs, aligning resources with product strategy and ensuring timely delivery. You will oversee outsourcing, vendor relationships, budgeting, SOPs and regulatory compliance (FDA/ICH-GCP), build a high‑performing team, and travel as needed...Remote job
- 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...
$275k - $280k
...breakthroughs.Position Description:The Director of Regulatory CMC will lead the development and execution of global CMC regulatory strategies for our pipeline of small molecules and... ...applications, ensuring technical consistency and compliance across all stages of the product...$265k - $285k
...****@*****.*** include: Provides regulatory leadership in support of the development, registration, and... ...to develop, coordinate, and implement global regulatory strategies and submissions, including CTAs, for new and ongoing clinical...$120.2k - $223.2k
The PositionCommercial Regulatory Affairs (CORA) is part of the Global... ....Associate Program Directors of Commercial Medical Legal... ...identifying and addressing compliance issues.Effectively integrate... ...leadership to influence marketing strategies and facilitate the timely development...Full timeWork experience placementLocal areaWorldwideRelocation package- BioSpace seeks a Director of Quality Control to lead QC strategy and execution in a fast-paced biotech setting. You will coordinate between Analytical Development, QA, and external CDMOs to ensure proper testing, release, and safety of clinical-stage products. The role...
$180k - $241k
...Primary Function: The Associate Director, Regulatory Affairs supports the development and execution of clinical regulatory strategies and regulatory development activities for... ...alignment with regulatory expectations. Compliance: Execute regulatory activities in...Full timeRemote workWorldwideRelocation package
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