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

Regulatory Strategy Leader — Global Submissions & Compliance

Jobleads-US

Sagimet seeks a visionary VP of Regulatory Affairs to shape global regulatory strategy and lead submissions for INDs, NDAs, and MAAs. You will be the primary liaison with FDA, EMA, and other agencies, guiding cross-functional teams to secure timely approvals and ensure regulatory compliance.

You will manage external regulatory vendors, oversee submission quality, and monitor regulatory trends to inform clinical development decisions.

#J-18808-Ljbffr Jobleads-US
Vacancy posted 7 hours ago
Similar jobs that could be interesting for youBased on the Regulatory Strategy Leader — Global Submissions & Compliance in San Mateo, CA vacancy
  • Revolution Medicines is seeking a senior Regulatory Operations leader to drive global submission execution and strategy. You will lead a submissions-focused team, partner with Regulatory Affairs, Medical Writing, Quality, and Clinical Operations, and oversee external publishing... 
    Regulatory

    Regulatory Jobs

    Redwood City, CA
    4 days ago
  • ImmunEdge is seeking an experienced Regulatory Affairs leader to develop and execute global regulatory strategies across its portfolio of innovative therapeutics. You will...  ...other health authorities while guiding teams through IND/CTA submissions #J-18808-Ljbffr ImmunEdge
    Regulatory

    ImmunEdge

    Redwood City, CA
    2 days ago
  •  ...Gilead Sciences seeks a Director of Global Value & Access Strategy for its cell-therapy autoimmune portfolio. The role involves developing and executing...  ...and commercialization, collaborating with clinical, regulatory, and commercial teams to ensure payer perspectives inform... 
    Regulatory

    Gilead Sciences

    Foster, CA
    3 days ago
  • $211k - $264k

    Revolution Medicines is a global, commercial-state oncology company...  ...Opportunity:The Director of Regulatory Affairs (Global Filing Lead)...  ...development & regulatory submission activities for...  ...effective & consistent regulatory strategies to enable successful filing... 
    Regulatory
    Full time
    Work experience placement
    Local area
    Worldwide

    Revolution Medicines

    Redwood City, CA
    17 hours ago
  •  ...Revolution Medicines seeks a Director of Regulatory Affairs to lead global regulatory filings for late-stage...  ...end-to-end NDA/MAA preparation and submission, coordinating cross-functional teams...  ...affairs experience including strategy role Proven track record executing... 
    Regulatory

    Revolution Medicines

    Redwood City, CA
    12 days ago
  • $302.01k - $390.83k

     ...believe every employee deserves a great leader. People Leaders are the cornerstone to the...  ....Executive Director, PDM Product Strategy LeaderKEY RESPONSIBILITIESReporting to the...  ...formulation development activities along with regulatory, supply chain, and quality strategies... 
    Regulatory
    Full time
    Part time
    For contractors
    Local area
    Worldwide

    GILEAD Sciences

    San Mateo, CA
    4 days ago
  •  ...in South San Francisco is seeking a Director Regulatory Affairs Global Regulatory Lead (GRL I) to develop and implement global regulatory strategies for assigned products, guiding lifecycle management and ensuring compliance with worldwide regulations. The role leads the... 
    Regulatory
    Worldwide

    Regulatory Jobs

    South San Francisco, CA
    4 days ago
  • $324.62k - $420.09k

     ...deserves a great leader. People Leaders are...  ...informing regulatory decisions across...  ..., Regulatory RWE Strategy and Innovation is...  ...and their teams, Global Regulatory Affairs...  ...programs, studies, submissions, and relationships...  ...rigor, quality and compliance expected by global... 
    Regulatory
    Full time
    For contractors
    Local area
    Immediate start
    Shift work

    GILEAD Sciences

    San Mateo, CA
    1 day ago
  •  ...Quality Lead in PDQ to shape quality assurance strategies across development and post-approval products, in a global matrix environment. You will drive CtQ framework...  ...worldwide; strong data analytics and regulatory knowledge required. This role offers competitive... 
    Regulatory
    Worldwide
    Relocation

    Jobleads-US

    South San Francisco, CA
    3 days ago
  •  ...and Tik Tok . The Director Regulatory Affairs Global Regulatory Lead (GRL I) in Global Regulatory Strategy is responsible for developing...  ...and supporting teams. Ensures compliance with global regulatory...  ...manager, acts as key internal leader and driver of regulatory policy... 
    Regulatory
    Worldwide

    Regulatory Jobs

    South San Francisco, CA
    17 hours ago
  • $182.1k - $338.3k

     ...Principal Content & Evidence Submission Strategy Lead is focused on...  ...interpret external legal and regulatory landscapes, and lead cross-...  ...coach, and advise teams and leaders to develop valuable solutions...  ...understanding of corporate legal and compliance, including GCP, OIG... 
    Regulatory
    Full time
    Local area

    Genentech

    South San Francisco, CA
    2 days ago
  •  ...Tue–Thurs in office. You will own end-to-end strategy, launch banking and wallet products, and lead P&L for a global payments business. Partner with...  ...Development to scale revenue while maintaining regulatory compliance. Strong background in financial products, risk... 
    Regulatory
    Work at office

    Jobleads-US

    San Mateo, CA
    17 hours ago
  •  ...Therapeutics seeks a Vice President / Senior Vice President, Global Development Leader to provide strategic and tactical medical leadership...  ...from phase 1 through launch. You will ensure safety, regulatory compliance, and alignment with corporate goals while coordinating... 
    Regulatory

    Nurix

    Brisbane, CA
    2 days ago
  •  ...is seeking a Senior Corporate Counsel, Global Regulatory & Litigation, to guide worldwide regulatory...  .... The role collaborates across Legal, Compliance, Privacy, Product, Engineering, and Finance to develop practical risk strategies and coordinate internal and external teams... 
    Regulatory
    Worldwide

    Jobleads-US

    San Mateo, CA
    7 hours ago
  • $210.38k - $272.25k

     ...deserves a great leader. People Leaders are...  ...& Contracting Strategy, Virology , you...  ...products. ~ Ensure compliance with all...  ...regulations and regulatory guidelines governing...  ...Government Affairs, Global Value & Access/Pricing...  ...and submissions for new contract... 
    Regulatory
    Full time
    Contract work
    Temporary work
    For contractors
    Local area

    Gilead Sciences

    Foster, CA
    a month ago
  •  ...Therapeutics, Inc. seeks a Director/Sr. Director, Regulatory Affairs (Strategy, Oncology – Solid Tumors) to lead global regulatory strategy and oversee registrations...  ...cross-functional teams to ensure high-quality submissions and strategic global regulatory input. The position... 
    Regulatory

    BioSpace

    Brisbane, CA
    2 days ago
  •  ...United States is seeking a Director, Regulatory CMC to lead global regulatory activities for small...  ...and monoclonal antibodies, shaping strategies for accelerated development and successful...  ...and Manufacturing teams to prepare submissions (NDA, BLA, MAAs), maintain the CTD,... 
    Regulatory

    Enigma Search

    South San Francisco, CA
    2 days ago
  • $205.62k - $266.09k

     ...believe every employee deserves a great leader. People Leaders are the cornerstone...  ...We are seeking a Director, Global Value & Access Strategy (GVAS), Cell-therapy Autoimmune. This...  ...Medical Affairs, HEOR/RWE, Commercial, Regulatory Affairs and regional Access teams to... 
    Regulatory
    Full time
    For contractors
    Work at office
    Local area

    Gilead Sciences

    Foster, CA
    4 days ago
  •  ...Responsibilities Direct planning and execution of highly complex global regulatory submissions and programs Partner with Regulatory Affairs Liaisons to develop and maintain global filing plans with regulatory milestones Oversee submission lifecycle execution and... 
    Regulatory

    Gilead Sciences

    Foster, CA
    12 days ago
  • $226.2k - $339.2k

     ...and an entertainment leader, home to some of the most...  ..., Litigation and Regulatory DisputesSan Mateo, CA;...  ...thrilling experiences to a global audience through our...  ...develop a clear response strategy and workplan.Manage...  ...stakeholders across Legal, Compliance, Privacy, Information... 
    Regulatory
    Worldwide

    Sony Interactive Entertainment America

    San Mateo, CA
    1 day ago
  •  ...medical leadership for global clinical...  ...across clinical, regulatory, research, quality...  ...clinical development strategy aligned with...  ...ensure regulatory compliance and standard procedures...  ...discussions and submissions; interact with...  ...investigators and opinion leaders Requirements... 
    Regulatory
    Contract work

    Nurix Therapeutics

    Brisbane, CA
    12 days ago
  •  ...Oncology is seeking a Clinical Trial Manager / Sr. CTM to drive global oncology trials from protocol through study completion. You...  ...meet timeline and budget while maintaining high quality. Strong regulatory knowledge and TMF stewardship are required. Preferred onsite two... 
    Regulatory

    ALX Oncology

    South San Francisco, CA
    4 days ago
  •  ...Director to lead enterprise-wide real-world evidence strategy and innovation for regulatory decision-making. This role will establish systematic approaches...  ...credible, compliant use of RWE in health authority submissions. Responsibilities Partner with therapeutic-area... 
    Regulatory

    Gilead Sciences

    Foster, CA
    12 days ago
  •  ...Description: The Associate Director, Portfolio Strategy & Decision Intelligence provides the...  ....g., companion diagnostics, accelerated regulatory pathways, HTA frameworks, combination/...  ..., Systems and Reporting), R&D Finance, Global Commercial Strategy & Operations to... 
    Regulatory
    Work at office

    BeOne Medicines Ltd.

    San Mateo, CA
    1 day ago
  • $203.8k - $326.1k

    About UsVisa is a world leader in payments technology, facilitating...  ...seeking a Director, Product Strategy & Operations to help lead the...  ..., competitive dynamics, regulatory movement, and tech innovation...  ...initiatives in highly matrixed global organizations.Experience building... 
    Regulatory
    Full time
    Work experience placement
    Work at office
    Local area
    Flexible hours
    Shift work

    Visa

    Foster, CA
    4 days ago
  • $246.7k - $370.1k

     ...people and an entertainment leader, home to some of the...  ...Corporate Counsel, Legal - Global Sales and Business...  ...distribution, including compliance, negotiation of contracts, and strategy of different models as well...  ...government affairs and regulatory developments in the region... 
    Regulatory
    Relocation package
    2 days per week

    Sony Interactive Entertainment America

    San Mateo, CA
    1 day ago
  •  ...Director position leading regulatory strategy for hematology-oncology programs...  ...for building and executing global regulatory strategies,...  ...applications, and ensuring compliance across investigational and...  ...compliance Prepare regulatory submissions including INDs, NDAs, DSURs... 
    Regulatory

    Nurix Therapeutics

    Brisbane, CA
    12 days ago
  • $141.1k - $262.1k

     ...clinical programs, resolving complex compliance challenges before they impact study timelines or regulatory integrity.Develop strategic...  ...and proactive risk-mitigation strategies to support early clinical...  ...participate in intradepartmental, global, and cross-functional... 
    Regulatory
    Local area
    Relocation package
    3 days per week

    Genentech

    South San Francisco, CA
    4 days ago
  •  ...Revolution Medicines seeks an Associate Director of Global Regulatory Affairs Project Management to oversee submission timelines and execution plans for oncology drug...  ...programs. This role translates regulatory strategies into actionable plans, coordinating cross-functional... 
    Regulatory

    Revolution Medicines

    Redwood City, CA
    12 days ago
  • $174.7k - $324.5k

     ...Principal Clinical Quality Compliance and Policy Lead, you will serve...  ..., translating complex global regulatory requirements into pragmatic...  ...robust clinical compliance strategies that advance our groundbreaking...  ...Problem Solver & Matrix Leader: You have a proven track record... 
    Regulatory
    Local area
    Relocation package
    3 days per week

    Genentech

    South San Francisco, CA
    4 days ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Regulatory Strategy Leader — Global Submissions & Compliance. Be the first to apply!