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

Senior CMC Regulatory Lead - AI‑Driven Submissions

BridgeBio

BridgeBio seeks a Senior Manager / Associate Director, CMC Regulatory Sciences in the San Francisco area for a hybrid role. The candidate will collaborate with CMC technical teams to design control strategies, author and review regulatory submissions, and respond to health authority queries to support global filings. You will drive strategies aligned with ICH and regional requirements, interface with regulatory affairs, and leverage AI tools to improve submission quality and speed across #J-18808-Ljbffr BridgeBio

Vacancy posted 1 day ago
Similar jobs that could be interesting for youBased on the Senior CMC Regulatory Lead - AI‑Driven Submissions in San Francisco, CA vacancy
  • Veratherapeuticsinc seeks a Senior Manager, Regulatory CMC to manage regulatory submissions and activities within a dynamic team. This role requires strong regulatory...  ..., organizational skills, and the ability to lead cross-functional projects. Candidates should have... 
    Senior
    Regulatory

    Veratherapeuticsinc

    Brisbane, CA
    3 days ago
  •  ...compliance analyst to shape and lead our program. You will drive...  ...ISO 27001 and HIPAA, ensuring regulatory alignment and scalable audit processes...  ...on trustworthy search and AI‑assisted experiences. The role...  ..., and Engineering in a data‑driven environment. #J-18808-Ljbffr... 
    Senior
    Regulatory

    Perplexity

    San Francisco, CA
    2 days ago
  • Penfield Search Partners Ltd is seeking a Senior Regulatory Submission Lead to drive a BLA submission across Module 2 and Module 5 for a Bay Area-based project. This 1-year contract role emphasizes hands-on submission execution, cross-functional coordination, and regulatory... 
    Senior
    Regulatory
    Contract work

    Penfield Search Partners Ltd

    San Francisco, CA
    4 days ago
  •  ...role:Wells Fargo is seeking a Senior Lead Data Management Analyst to...  ...understanding of data risk management, regulatory expectations, and control...  ..., automation, analytics, and AI-enabled solutions to improve...  ...mitigating and compliance-driven culture which firmly establishes... 
    Senior
    Regulatory
    Full time
    Work experience placement
    Work at office
    Remote work

    Wells Fargo

    San Francisco, CA
    18 hours ago
  • $120 - $175 per hour

     ...penfieldsearch.comNo 3rd party candidatesLocation: Bay Area-based roleWork Model: 5 days onsite per weekWe are seeking a Senior Regulatory Submission Lead to support a critical BLA submission across Module 2 and Module 5. This 1 year contract role will provide hands-on... 
    Senior
    Regulatory
    Hourly pay
    Contract work

    Penfield Search Partners Ltd

    San Francisco, CA
    4 days ago
  •  ...highly skilled and experienced Senior Lead Application Pen Testing Cyber...  ...capabilities in offensive AI, scanning, and security research...  ...mitigating and compliance-driven culture which firmly establishes...  ...Crimes, Operational, Regulatory Compliance), which includes effectively... 
    Senior
    Regulatory
    Full time
    Work experience placement
    Remote work

    Wells Fargo

    San Francisco, CA
    3 days ago
  • A healthcare technology company in San Francisco is seeking a Staff Regulatory Affairs Engineer. The role involves leading regulatory submissions for AI/ML software, developing regulatory strategies, and ensuring compliance with FDA regulations. The ideal candidate has... 
    Regulatory

    Hinge Health

    San Francisco, CA
    4 days ago
  • $261k - $304.5k

     ...suffering from diseases of cardiac muscle dysfunction. The Senior Director, CMC Lead is a unique opportunity to transform CMC product...  ...between clinical research, clinical supply chain, CMC, quality, regulatory, program & portfolio management. This role will include direct... 
    Senior
    Regulatory

    Cytokinetics

    San Francisco, CA
    1 day ago
  • $244k - $305k

     ...pathway. The Opportunity: The Senior Director, Molecule Global Regulatory Lead will develop and execute...  ...enable rapid, science-driven development while...  ...functional teams. Regulatory Submission Leadership Provide...  ...Development, Biometrics, and CMC to deliver high-quality... 
    Senior
    Regulatory
    Full time
    Local area

    Revolution Medicines

    San Francisco, CA
    23 hours ago
  • CareDx, Inc. is seeking a Sr. Staff Biostatistician to lead statistical and bioinformatics activities across solid organ transplantation...  ...in pharma/biotech, expert R/SAS skills, and a collaborative mindset to mentor staff and support regulatory submissions. #J-18808-Ljbffr Doist
    Senior
    Regulatory

    Doist

    Brisbane, CA
    23 hours ago
  •  ...through innovative, science‑driven drug development. This...  ...: Reporting to the Senior Vice President, Regulatory Affairs, the Senior Director...  ..., Regulatory Affairs, CMC, will serve as the lead CMC regulatory expert...  ...compliance of all CMC submission components. Provide... 
    Senior
    Regulatory

    Kaye/Bassman International

    San Francisco, CA
    1 day ago
  • Kastle is building the AI employee for consumer lending in San Francisco. We partner...  ...deployments, adoption, and compliance. You’ll lead strategic deployments, work cross-...  ...craft prompts and workflows to meet evolving regulatory needs while maintaining a high-energy... 
    Senior
    Regulatory

    Kastle

    San Francisco, CA
    3 days ago
  • $230k - $275k

     ...Senior Director, Commercial Manufacturing & CMC Development Eidos Therapeutics,...  ...product quality, regulatory compliance, and on...  ...manufacturing processes Lead and advise on CMC-...  ...for regulatory submissions, ensuring...  ...fast-paced, data-driven environment where... 
    Senior
    Regulatory
    Worldwide
    Flexible hours

    BridgeBio

    San Francisco, CA
    1 day ago
  •  ...compliance and risk management program. You will lead the implementation of frameworks, oversee...  ...in audit/compliance, automation using AI, and collaboration across IT, Security,...  ...help drive customer trust by staying ahead of regulatory developments. #J-18808-Ljbffr Apply
    Senior
    Regulatory

    Apply

    San Francisco, CA
    3 days ago
  • Kaye/Bassman International is assisting a late-stage biopharmaceutical company in seeking a Senior Director, Regulatory Affairs, CMC. This lead CMC regulatory expert role partners with Regulatory Affairs, Technical Operations, and Development teams to drive global CMC strategy... 
    Regulatory

    Kaye/Bassman International

    San Francisco, CA
    1 day ago
  •  ...automated campaigns across email, lifecycle, and lead nurture programs. You will balance...  ...precision with creative judgment, use AI tools to accelerate content development and...  ...compliance teams to ensure brand standards and regulatory requirements are met. #J-18808-Ljbffr... 
    Senior
    Regulatory

    Tally

    San Francisco, CA
    1 day ago
  •  ...requires extensive experience in information security, particularly with cloud environments and regulatory compliance. You'll work closely with engineering teams, leading SOC 2 audits and developing robust security strategies. The ideal candidate has a history of driving... 
    Regulatory

    HEN Technologies

    San Francisco, CA
    1 day ago
  • $140k - $214k

     ...guide how we work together every day. We lead with empathy, act with an owner’s...  .... Position Summary:Vera is seeking a Senior Manager, Regulatory CMC to join an experienced, fast-paced and...  ...teamto lead and support regulatory submissions and activities in the US and globally... 
    Senior
    Regulatory
    Contract work
    For contractors
    Flexible hours

    Vera Therapeutics

    Brisbane, CA
    3 days ago
  • Roamly seeks a Senior Product Manager to drive end-to-end delivery across RV insurance, carsharing...  ...backlog, define metrics, and leverage AI tools to produce spec, wireframes, and...  ..., refine user experiences, and ensure regulatory compliance while delivering value to #J-... 
    Senior
    Regulatory

    Outdoorsy

    San Francisco, CA
    1 day ago
  • Crowe is seeking a Cybersecurity Senior Consultant to help organizations navigate evolving threat landscapes and complex regulatory environments, delivering practical cybersecurity and...  ..., design security programs, and implement AI-informed security measures. This role... 
    Senior
    Regulatory

    Crowe

    San Francisco, CA
    2 days ago
  • $139k - $260k

     ...About this role: The Technology AI Transformation & Governance team is seeking a Senior Lead Business Execution Consultant...  ...frameworks, risk management, and regulatory requirements. Experience...  ...risk mitigating and compliance-driven culture which firmly establishes... 
    Senior
    Regulatory
    Full time
    Work experience placement
    Relocation package

    Wells Fargo

    San Francisco, CA
    1 day ago
  • Guild.ai is hiring a Senior Product Operations Manager, AI & Systems to design and refine operational...  .... You will own roadmap communications, lead tooling evaluations, and coordinate...  ...speed and impact, while applying a data-driven approach across the organization. This... 
    Senior
    Remote work

    Guild.ai

    San Francisco, CA
    14 hours ago
  • Qualia, the leading real estate tech company, is seeking a Senior Manager of FP&A in San Francisco to shape planning and forecasting at scale. You will own end-...  ...requirement, you will build scalable FP&A processes, advance AI-powered workflows, and elevate the speed and quality... 
    Senior
    Work at office

    QUALIA

    San Francisco, CA
    2 days ago
  • Gusto is hiring a Social Media Manager to own organic social strategy and execution across our brand channels. This role leads day-to-day content strategy, agency collaboration, and executive amplification, and is the backbone of the internal social team. You will work... 
    Senior

    Triwill Group

    San Francisco, CA
    3 days ago
  • Capgemini Invent is seeking a Sr. Consultant in San Francisco, responsible for managing client relationships, leading workstreams, and supporting practice growth. Candidates should have 5-10 years in management consulting, focused on analytics in the Life Sciences sector... 
    Senior

    Capgemini Invent

    San Francisco, CA
    1 day ago
  • $70 - $95 per hour

    A leading technology firm is seeking a Senior Strategic Partner Manager - Payments to lead partnerships within the payments ecosystem. The role involves executing...  ..., strong leadership skills, and proficiency with AI tools. This full-time position allows for remote work... 
    Senior
    Remote job
    Hourly pay
    Full time

    Crossing Hurdles

    San Francisco, CA
    3 days ago
  • Checkr is seeking a Senior Manager, Strategic Finance - Go-to-Market to partner...  ...and build the StratFin function with AI-powered workflows. You will lead planning, develop forecasting...  ...drive top-line growth through data-driven recommendations. This role reports to... 
    Senior

    Doist

    San Francisco, CA
    14 hours ago
  • $130k - $179k

     ...innovations and fueled by industry leading agentic AI technology, Corelight helps...  ...Centers (SOCs). As the Senior Product Manager for the AI...  ...evaluate detection accuracy and regulatory compliance. Knowledge/...  ...with clear success using data-driven workflows and customer discovery... 
    Senior
    Regulatory

    Corelight

    San Francisco, CA
    1 day ago
  •  ...seasoned Product Marketing Manager. This role focuses on establishing positioning and narrative for various audiences, leading product launches, and leveraging AI tools like Claude to enhance workflow. The ideal candidate has over 8 years of experience in product marketing... 
    Senior

    Nash

    San Francisco, CA
    3 days ago
  • House Rx is expanding its product team and seeks an experienced Senior Product Manager to scale its specialty medication platform. You...  ...-first role emphasizes empathy, creative problem solving, and regulatory awareness, with collaboration across stakeholders and direct customer... 
    Senior
    Regulatory
    Remote work

    House Rx

    San Francisco, CA
    2 days ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Senior CMC Regulatory Lead - AI‑Driven Submissions. Be the first to apply!