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
- 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...SeniorRegulatory
- ...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...SeniorRegulatory
- 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...SeniorRegulatoryContract work
- ...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...SeniorRegulatoryFull timeWork experience placementWork at officeRemote work
$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...SeniorRegulatoryHourly payContract work- ...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...SeniorRegulatoryFull timeWork experience placementRemote work
- 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
$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...SeniorRegulatory$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...SeniorRegulatoryFull timeLocal area- 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 DoistSeniorRegulatory
- ...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...SeniorRegulatory
- 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...SeniorRegulatory
$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...SeniorRegulatoryWorldwideFlexible hours- ...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 ApplySeniorRegulatory
- 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
- ...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...SeniorRegulatory
- ...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
$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...SeniorRegulatoryContract workFor contractorsFlexible hours- 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-...SeniorRegulatory
- 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...SeniorRegulatory
$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...SeniorRegulatoryFull timeWork experience placementRelocation package- 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...SeniorRemote work
- 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...SeniorWork at office
- 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
- 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
$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...SeniorRemote jobHourly payFull time- 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
$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...SeniorRegulatory- ...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
- 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...SeniorRegulatoryRemote work
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