Sign up to access all features of our service.
  • Job search
  • Favorites
  • Create a CV
    New
  • Salaries
  • Subscriptions

Director, REMS Regulatory Strategy & Compliance

$263.88k - $307.86k

Cytokinetics

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

Vacancy posted 3 days ago
Similar jobs that could be interesting for youBased on the Director, REMS Regulatory Strategy & Compliance in South San Francisco, CA vacancy
  • $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... 
    Suggested
    For contractors

    Cytokinetics

    South San Francisco, CA
    3 days ago
  • 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

    Initial Therapeutics, Inc.

    Brisbane, CA
    4 days ago
  • 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

    Kardigan, Inc.

    South San Francisco, CA
    1 day ago
  • $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... 
    Suggested
    For contractors
    Worldwide

    Initial Therapeutics, Inc.

    Brisbane, CA
    4 days ago
  • 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... 
    Suggested
    Work at office
    2 days per week

    Initial Therapeutics, Inc.

    South San Francisco, CA
    4 days ago
  • 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... 

    NURIX

    South San Francisco, CA
    1 day ago
  • 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... 

    Socket.dev

    South San Francisco, CA
    2 days ago
  • 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... 

    Calico Life Sciences

    South San Francisco, CA
    1 day ago
  • 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,... 

    Kardigan

    South San Francisco, CA
    3 days ago
  • 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, Inc.

    South San Francisco, CA
    5 days ago
  • $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 contractors
    Work at office

    NURIX

    South San Francisco, CA
    1 day ago
  • 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... 

    Kardigan

    South San Francisco, CA
    1 day ago
  • $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 time
    Temporary work
    For contractors
    Work experience placement
    Local area

    Pattern Energy

    San Francisco, CA
    4 days ago
  • $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 time
    For contractors
    Local area
    Immediate start
    Shift work

    GILEAD Sciences

    Foster, CA
    1 day ago
  •  ...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... 

    Denali Therapeutics Inc.

    South San Francisco, CA
    4 days ago
  • $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

    Calico Life Sciences

    South San Francisco, CA
    3 days ago
  • 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... 

    Sentibio

    South San Francisco, CA
    2 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... 
    Work at office

    Zai-Lab-

    South San Francisco, CA
    2 days ago
  • $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 office
    Worldwide
    Relocation package

    Zai-Lab-

    South San Francisco, CA
    2 days ago
  •  ...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

    Allergan

    South San Francisco, CA
    2 days ago
  • 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... 

    Denali Therapeutics

    South San Francisco, CA
    1 day ago
  • $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 time
    Contract work
    Local area
    Relocation package

    Genentech

    South San Francisco, CA
    6 hours ago
  •  ...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... 

    BioSpace

    South San Francisco, CA
    1 day ago
  •  ...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

    Lycia Therapeutics, Inc.

    South San Francisco, CA
    1 day 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... 

    AbbVie

    South San Francisco, CA
    3 days ago
  • $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... 

    Calico Life Sciences

    South San Francisco, CA
    1 day ago
  • $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... 

    Planet Pharma

    Brisbane, CA
    9 days ago
  • $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 time
    Work experience placement
    Local area
    Worldwide
    Relocation package

    Genentech

    South San Francisco, CA
    4 days ago
  • 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... 

    BioSpace

    South San Francisco, CA
    1 day ago
  • $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 time
    Remote work
    Worldwide
    Relocation package

    Zai Lab (US) LLC

    South San Francisco, CA
    8 days ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Director, REMS Regulatory Strategy & Compliance. Be the first to apply!