Senior Regulatory Affairs Specialist Procept Biorobotics CorpSenior Regulatory Affairs SpecialistSan Jose, CA$148,550–$174,770 / yearIt continues with our one-of-a-kind management program designed to build the best managers in the industry, where our people managers across functions come together to exchange ideas and grow, as both managers and learners, in an environment that challenges, supports and broadens. Act as a lead regulatory representative on product development teams, communicate regulatory requirements and impact of regulations to project teams, and provides input related to FDA and international product registrations and licensing requirements.
Regulatory Affairs Specialist 4 Iconma LLCRegulatory Affairs Specialist 4Sunnyvale, CARequirements: Minimum 8 years of regulatory affairs experience working in a medical device company (can be in combination with a regulatory affairs master degree; e.g., Masters in Regulatory Science). Regulatory working knowledge of product lifecycle management, design controls, risk management, verification and validation, and product labeling requirement.
Senior Regulatory Affairs Specialist Hyperfine IncSenior Regulatory Affairs SpecialistPalo Alto, CA$145,000–$167,000 / yearHyperfine, Inc. (Nasdaq: HYPR) is the groundbreaking health technology company that has redefined brain imaging with the Swoop system-the first FDA-cleared, portable, ultra-low-field, magnetic resonance brain imaging system capable of providing imaging at multiple points of care in a healthcare facility. Key Responsibilities: Assess and advise regulatory strategies to optimize business expectations related to domestic and international commercial product availability and regulations: Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions.
Regulatory Affairs Specialist II The Clorox CoRegulatory Affairs Specialist IIPleasanton, CA$90,900–$170,100 / yearThis role requires strong cross-functional collaboration, working daily with partners across R&D (e.g., Product Development), Product Safety, Legal, Corporate Quality, Government Affairs, and Consumer Affairs. Work with Consumer Affairs to develop consumer-facing responses, providing regulatory guidance to ensure accuracy, consistency, and appropriate interpretation of product claims, ingredients, and safety information.
Senior Regulatory Affairs Specialist LancesoftSenior Regulatory Affairs SpecialistSanta Clara, CA$43.80Proactively manages the changing regulatory environment for company products, prevents barriers to trade, eliminates duplication of effort and identifies and mitigates areas of risk. Prepares document packages for regulatory submissions for new and mature products to ensure alignment and compliance with local and regional registration requirements and company policies as required.
NewRegulatory Specialist Sr Actalent IncRegulatory Specialist SrAlameda, CAWe are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing winner for both client and talent service. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
Regulatory Submission Publishing Specialist Tailored ManagementRegulatory Submission Publishing SpecialistPleasanton, CA$24.16–$36.02 / hourThe ideal candidate will manage and facilitate the preparation, submission, and publishing process of regulatory submissions intended for registration. Liaise with project leads, project teams, and regulatory bodies to gather.
Staff Regulatory Affairs Specialist - Pleasanton, CA CalyxoStaff Regulatory Affairs Specialist - Pleasanton, CAPleasanton, CA$160,000–$175,000 / yearMaster's degree with a minimum of 8 years of directly relevant regulatory affairs experience, or Bachelor's degree with a minimum of 10 years of directly relevant regulatory affairs experience, in the medical device, biotechnology, or in vitro diagnostics (IVD) industry, including substantial experience with Class II or Class III electromechanical medical devices. As a senior member of the Calyxo Regulatory Team, you will work closely with Research & Development, Operations, Quality, Clinical and Medical Affairs, Marketing, and Legal to ensure regulatory alignment from concept through commercialization—balancing speed with compliance as we bring category-defining medical devices to market.
Staff Regulatory Affairs Specialist - Pleasanton, CA Calyxo IncStaff Regulatory Affairs Specialist - Pleasanton, CAPleasanton, CA$160,000–$175,000 / yearRequirements: Master''s degree with a minimum of 8 years of directly relevant regulatory affairs experience, or Bachelor''s degree with a minimum of 10 years of directly relevant regulatory affairs experience, in the medical device, biotechnology, or in vitro diagnostics (IVD) industry, including substantial experience with Class II or Class III electromechanical medical devices. As a senior member of the Calyxo Regulatory Team, you will work closely with Research & Development, Operations, Quality, Clinical and Medical Affairs, Marketing, and Legal to ensure regulatory alignment from concept through commercialization-balancing speed with compliance as we bring category-defining medical devices to market.
Regulatory Submission Publishing Specialist Pride GlobalRegulatory Submission Publishing SpecialistPleasanton, CARemote$24.51–$36.54 / hourProficiency with Microsoft Word, Adobe Acrobat Pro, ISI Toolbox, Veeva RIMS, US Health Authority portals, and other publishing tools. Coordinate with Regulatory Affairs teams and project stakeholders to ensure timely submissions.
Regulatory Submission Publishing Specialist MindlanceRegulatory Submission Publishing SpecialistPleasanton, CA$34.31–$51.15 / hourThe ideal candidate will manage and facilitate the preparation, submission, and publishing process of regulatory submissions intended for registration. Liaise with project leads, project teams, and regulatory bodies to gather.
Sr. Regulatory Affairs Specialist , Medical Devices Operational Compliance Center (MD-OCC) Amazon.com IncSr. Regulatory Affairs Specialist , Medical Devices Operational Compliance Center (MD-OCC)Sunnyvale, CAActs as a regulatory representative on core product development teams, communicates regulatory requirements and impact of regulations to project teams, and provides input related to FDA and international product registrations and licensing requirements. The Quality & Lean, Medical Devices Operational Compliance Center (MD-OCC), consists of business process analysts, quality system experts, program managers, supply chain experts, regulatory experts, clinical affairs, and internal auditors.
Regulatory Compliance Specialist The Surplus Line Association of CaliforniaRegulatory Compliance SpecialistSan Ramon, California$77,000–$115,000Each year we review more than 1 million policy transactions, equip insurance brokers with compliance tools and continuing education courses, monitor the financial stability of global insurers and deliver data-driven insights that help the industry stay ahead of emerging risks. You will help interpret and communicate surplus line requirements, support compliance processes and guidelines, respond to member inquiries, and contribute to educational programs, publications, webinars, and operational improvements .
Regulatory Operations Specialist - Temporary Twist Bioscience CorpRegulatory Operations Specialist - TemporarySouth San Francisco, CA$31–$42 / hourThe Regulatory Operations Specialist is responsible for ensuring the efficient and compliant management of regulatory documentation, with a primary focus on Safety Data Sheets (SDS), product labeling, and SOP's. Strong written and oral communication skills (timely, clear, concise, accurate, conclusive, influential, targeted to audience) required.
QA Specialist III - Analytical (Small Molecule) Ardelyx, Inc.QA Specialist III - Analytical (Small Molecule)Newark, CA$105,000–$129,000 / yearThe Quality Assurance Specialist III, Analytical is responsible for the review and approval of analytical quality documentation supporting commercial and clinical products, including intermediates, drug substances (APIs), and drug products manufactured and tested by Ardelyx contract manufacturing organizations (CMOs) and contract laboratories. A strong background in small molecule analytical methodologies (e.g., wet chemistry, HPLC/UPLC, GC, dissolution, and other compendial techniques) is essential to support the review of in-process, release, validation, and stability analytical documentation.
Strategy and Operations Lead, Regulatory Affairs Google LLCStrategy and Operations Lead, Regulatory AffairsMountain View, CA10 years of experience in management consulting, operations, business strategy, regulatory, legal or corporate advisory, or 8 years of experience with an advanced degree. Advise Regulatory Affairs leadership on critical OKRs, business plans, and operating plans while defining change management strategies to implement new initiatives.
Senior Program Director, Commercial Regulatory Affairs Compass ConsultingSenior Program Director, Commercial Regulatory AffairsSouth San Francisco, CAProgram Directors in CORA chair Program Review Committees (PRCs) for their assigned responsibilities, e.g., products within a designated therapeutic area(s) or cross-portfolio activities, such as managed care, interactive marketing, etc. Program Directors lead and manage the assigned PRCs and their activities; providing strategic and operational leadership in the areas of advertising and promotion regulatory review and approval for Roche pharmaceutical products.
Senior Program Director, Commercial Regulatory Affairs LancesoftSenior Program Director, Commercial Regulatory AffairsSouth San Francisco, CA$129.714 or more years previous experience leading large-scale, cross-functional project teams or other forums in design, development and implementation of policies, programs or projects with significant organizational impact strongly preferred. Senior Program Directors may be assigned responsibilities for leading complex product launches, combination product PRCs, departmental programs, projects or other deliverables with limited direction.
Senior Program Director, Commercial Regulatory Affairs SGA Inc.Senior Program Director, Commercial Regulatory AffairsSouth San Francisco, CAResponsibilities : Commercial Regulatory Affairs (CORA) is part that interprets the needs of worldwide health authorities and provides regulatory intelligence necessary to generate and present information that meets the needs of health authorities, patients, purchasers and prescribers for the firm's global Pharma Division, which includes all therapeutic areas and all phases of product development from early development to post marketing. Must demonstrate in-depth knowledge of the bio/pharma industry (compliance, legal, clinical affairs, regulatory and product marketing) as well as in-depth knowledge of the legal and regulatory environment, as it relates to healthcare compliance in the bio/pharma industry (includes anti-kickback statutes, government fraud & abuse, off-label promotion, PhRMA Code, etc.).
Regulatory Affairs Expert - Remote YO AI LabsRegulatory Affairs Expert - RemotePalo Alto, CARemoteThe role involves assessing clinical documents, ensuring compliance with regulatory guidelines, identifying inconsistencies, and providing clear, evidence-based feedback to improve AI-generated regulatory content. We are seeking an experienced Regulatory Affairs Specialist to support AI-driven healthcare projects by reviewing and evaluating regulatory documentation.
Senior Director, Regulatory Affairs Policy, Regulatory Intelligence & Compliance Exelixis IncSenior Director, Regulatory Affairs Policy, Regulatory Intelligence & ComplianceAlameda, CAThe position oversees the surveillance, triage, interpretation, and dissemination of global regulatory intelligence across Research & Development (R&D), Quality (QA), Information Technology (IT) and Pharmaceutical Supply Chain (PSC), partnering with cross-functional subject matter experts to ensure impact assessments are conducted and documented. EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS: Education: BA/BA degree in related discipline and 15 years of related experience; or, MA/MA degree in related discipline and 13 years of related experience; or, PhD in related discipline and 12 years of related experience; or, Equivalent combination of education and experience.
NewRegulatory Counsel and Manager, Regulatory Response Google LLCRegulatory Counsel and Manager, Regulatory ResponseMountain View, CAYou will lead a high-performing team of tech-forward Program Managers (PgMs) and advise on how we leverage AI to scale our matter management and execution safely, ensuring that our shift toward automated, human-in-the-loop regulatory workflows is legally sound and defensible. Oversee the strategic execution of certain matters and processes across Regulatory Affairs, advising on the development of highly efficient, AI-forward workflows and supporting technical solutions.
Regulatory Affairs Quality/Standards/Training Manager - Remote Roth Staffing CompaniesRegulatory Affairs Quality/Standards/Training Manager - RemoteAlameda, CaliforniaRemote$85–$93.68 / hourCollaborate with Quality Assurance and cross‑functional stakeholders to support health authority inspections across GPS and Regulatory Affairs, ensuring the RA function remains in a continuous state of inspection readiness. · Work with Regulatory Affairs Strategist, CRO and Clinical Operations to ensure the Trial Master File (TMF) and Veeva RIM is kept current and complete for Regulatory Affairs-related documents.
Senior Director, Regulatory Affairs Orca BioSenior Director, Regulatory AffairsMenlo Park, CA$250,000–$300,000 / yearEssential Duties & Key Responsibilities: Lead Orca Bio's Regulatory Affairs function and serve as the company's senior regulatory leader, working with the CMO, advising executive leadership on strategy, health-authority engagement, lifecycle planning, risks, and emerging requirements - with an immediate focus on post-approval operations, lifecycle management, and preparation for future major submissions. Following Orca Bio's recent commercial approval, the role's immediate focus is heavily weighted toward post-approval regulatory operations and lifecycle management, while also maintaining regulatory readiness for future development programs, new indications, global expansion, CMC Regulatory and other significant milestones as the pipeline evolves.
Director, Regulatory Affairs (Strategy, I&I) Nurix Therapeutics, Inc.Director, Regulatory Affairs (Strategy, I&I)Brisbane, CAThis role will be responsible for developing the global regulatory strategy in collaboration with key internal stakeholders, as well as tactical implementation of that strategy guiding and executing compliant, high quality, nonclinical and clinical submissions and interactions in support of early development, registration and life cycle management activities. Works strategically with all regulatory functions to develop detailed, actionable submission plans, tracks major submission deliverables, and ensures consistent management submission documents, health authority communications, and all other regulatory information supporting Nurix's investigational and marketing applications.
Senior Regulatory Affairs CMC Associate Iovance Biotherapeutics IncSenior Regulatory Affairs CMC AssociateSan Carlos, CARemote$140,000–$160,000 / yearWorks with submission authors and reviewers to ensure that source document planning is complete and that high-quality documents are approved on-schedule in terms of scientific content, organization, clarity, accuracy, format, consistency and adherence to regulatory guidelines, styles and processes. Mental: Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines.
Director / Sr. Director, Regulatory Affairs (Strategy, Oncology Solid Tumors) Nurix Therapeutics, Inc.Director / Sr. Director, Regulatory Affairs (Strategy, Oncology Solid Tumors)Brisbane, CA$232,000–$274,000 / yearThis role will be responsible for developing and executing the global regulatory strategy in collaboration with key internal stakeholders, as well as tactical implementation of that strategy, guiding and executing compliant, high quality, nonclinical and clinical submissions and interactions in support of registration and life cycle management activities. Works strategically with all regulatory functions to develop detailed, actionable submission plans, tracks major submission deliverables, and ensures consistent management submission documents, health authority communications, and all other regulatory information supporting Nurix's investigational and marketing applications.
Sr. Regulatory Affairs TalentBurst, Inc.Sr. Regulatory AffairsSunnyvale, CAStrong verbal and written communication skills, proven ability to translate technical documentation into effective internal documentation, and regulatory submissions. " Provide regulatory guidance to product teams, develop regulatory plans, and review and approve product design control documentation.
Associate Director, Regulatory Affairs Advertising And Promotion Mirum Pharmaceuticals IncAssociate Director, Regulatory Affairs Advertising And PromotionFoster City, CA$205,000–$225,000 / yearEducation /Experience: Bachelor's or advanced degree in a scientific discipline, with a minimum of 8 years in Regulatory Affairs with a minimum of 6 years of experience in the regulatory review of advertising and promotional materials for prescription drug and/or biologic products. Manage and author commercial regulatory submissions, working closely with the Publishing vendor to ensure timely publishing and submission of promotional materials to the Office of Prescription Drug Promotion (OPDP).
Senior Director, Regulatory Affairs CMC Mirum Pharmaceuticals IncSenior Director, Regulatory Affairs CMCFoster City, CA$280,000–$310,000 / yearThe Senior Director, Regulatory Affairs CMC is a position requiring a strong leader who will provide strategic and operational leadership, and who will ensure the effectiveness of the Regulatory Affairs CMC team within the Regulatory Affairs department and across the organization. Actively seeks out knowledge of overall corporate planning, business objectives, and current regulatory requirements to develop regulatory positions for assets in Mirum portfolio, and incorporates this knowledge into submission planning.
Associate Director, Regulatory Affairs Advertising and Promotion Mirum Pharmaceuticals IncAssociate Director, Regulatory Affairs Advertising and PromotionFoster City, CA$205,000–$225,000 / yearEducation /Experience: Bachelor's or advanced degree in a scientific discipline, with a minimum of 8 years in Regulatory Affairs with a minimum of 6 years of experience in the regulatory review of advertising and promotional materials for prescription drug and/or biologic products. Manage and author commercial regulatory submissions, working closely with the Publishing vendor to ensure timely publishing and submission of promotional materials to the Office of Prescription Drug Promotion (OPDP).
NewManager, Regulatory Response Google LLCManager, Regulatory ResponseMountain View, CAAs a Manager on the Regulatory Response Team, you will work closely with members of Global Affairs and act as a team lead for a team of project managers that partner with counsel, to coordinate how Google responds to inquiries and investigations by government and regulatory agencies worldwide. As a Program Manager at Google, you'll lead complex, multi-disciplinary projects from start to finish - working with stakeholders to plan requirements, manage project schedules, identify risks, and communicate clearly with cross-functional partners across the company.
NewSenior Program Manager, Regulatory Compliance Google LLCSenior Program Manager, Regulatory ComplianceSunnyvale, CAWe achieve this by meeting partners and consumers where they are with support and help, representing their needs with our product partners and proposing fixes and features that elevate their engagement with Google"s diverse product ecosystem. Exceptional communication and storytelling skills, with a track record of acting as a trusted consultant to executive leadership and guiding cross-functional teams without direct authority.
Senior Program Director, Commercial Regulatory Affairs Apollo Professional SolutionsSenior Program Director, Commercial Regulatory AffairsSouth San Francisco, CAPreferred Education and Experience: Bachelors degree in Life Sciences, Law, Public Policy, Business, or related field; advanced degrees such as JD, MBA, PharmD, MS, PhD preferred . Join a dynamic and innovative organization at the forefront of global healthcare as our Senior Program Director, Commercial Regulatory Affairs.
Associate Director, Regulatory Affairs CMC Iovance Biotherapeutics IncAssociate Director, Regulatory Affairs CMCSan Carlos, CARemote$140,000–$160,000 / yearMental: Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines. Organizational and planning skills; ability to influence and negotiate professionally at various levels within the project team and with external partners while maintaining positive working relationships.
Regulatory Affairs Manager Gateway RecruitingRegulatory Affairs ManagerSan Jose, CAThe candidate will combine knowledge of scientific, regulatory, and business issues to enable products, including combination products, that are developed, manufactured or distributed to meet required legislation. 2-5 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related areas.
Vice President, Regulatory Affairs Sight Sciences IncVice President, Regulatory AffairsMenlo Park, CAProven leadership in compliance with an ability to troubleshoot within FDA and international regulations and guidelines including, but not limited to, clinical strategy, GCPs, GLPs, SOPs, submissions, product launch, labeling, advertising and promotion, product vigilance, and medical device reporting. He or she should know regulatory road maps for medical devices and preferably combination drug-device products, which will speed up the clinical trial cycle, the regulatory process and garner more government resources.
Senior Manager Regulatory Affairs (Contract) Alumis Inc.Senior Manager Regulatory Affairs (Contract)South San Francisco, CA$165,000–$195,000 / yearBachelor's or advanced degree in scientific discipline, with a minimum of 5 years of experience working in drug development in the biopharmaceutical industry and at least 3 years of experience in Regulatory Affairs; immunology or rare disease/ orphan drug development experience desirable. We are seeking an exceptionally motivated individual to provide leadership and support to global regulatory activities to achieve Alumis' strategic vision in obtaining worldwide approvals to market our products.
Senior Manager Regulatory Affairs contract Alumis IncSenior Manager Regulatory Affairs contractSouth San Francisco, CA$165,000–$195,000 / yearEDUCATION/EXPERIENCE/SKILLS: Bachelor's or advanced degree in scientific discipline, with a minimum of 5 years of experience working in drug development in the biopharmaceutical industry and at least 3 years of experience in Regulatory Affairs; immunology or rare disease/ orphan drug development experience desirable. We are seeking an exceptionally motivated individual to provide leadership and support to global regulatory activities to achieve Alumis' strategic vision in obtaining worldwide approvals to market our products.
Executive Director, Regulatory Affairs CMC AllakosExecutive Director, Regulatory Affairs CMCRedwood City, CaliforniaLeads the development of strategic CMC plans and tactical implementation for the creation and submission of Regulatory documents, e.g., INDs, BLAs, CTAs, MAAs, and other relevant regulatory filings. Exec Director Regulatory Affairs/CMC Allakos Inc. is a dynamic clinical-stage biopharmaceutical company developing first-in-class antibody-based therapeutics to treat allergic and inflammatory diseases.
VP Quality & Regulatory Affairs Alexza Pharmaceuticals, Inc.VP Quality & Regulatory AffairsFremont, CAProvide executive oversight of Quality Assurance activities, including but not limited to: Quality Systems, Document Control, Training, Change Control, Deviations, CAPA (including timely implementation and closure), Audits (internal, external and supplier), Risk Management, and Product Release. 15+ years of progressive relevant senior regulatory and QA/QC experience, including at least 8 years executive level experience, in the Pharma biotechnology/pharmaceutical industry with direct regulatory affairs experience with drug/device combination products.
Regulatory Affairs Strategy Director Roth Staffing CompaniesRegulatory Affairs Strategy DirectorAlameda, California$133.33–$153.33 / hourBachelor's degree in related discipline and a minimum of thirteen years of related experience; or, · Master's degree in related discipline and a minimum of eleven years of related experience; or, · PhD degree in related discipline and a minimum of eight years of related experience; or, · Equivalent combination of education and experience. Leads the systematic collection, analysis, and dissemination of regulatory intelligence to proactively inform our client's policies, processes, and practices, enabling subject matter experts to assess the impact of evolving global regulatory requirements and translate regulatory changes into actionable guidance.
Senior Director, Regulatory Affairs (Oncology) Exelixis IncSenior Director, Regulatory Affairs (Oncology)Alameda, CA$248,000–$352,500 / yearEDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS: Education/Experience: Bachelor's degree in related discipline and a minimum of fifteen years of related experience; or, Master's degree in related discipline and a minimum of thirteen years of related experience; or, PhD degree in related discipline and a minimum of twelve years of related experience; or, Equivalent combination of education and experience. Lead, author and evaluate documents submitted to regulatory health authorities to ensure they are complete, organized, of high quality, contain appropriate messaging and compliant with applicable regional regulations.
Manager, Regulatory Affairs Iovance Biotherapeutics IncManager, Regulatory AffairsSan Carlos, CARemote$140,000–$160,000 / yearMental: Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines. Organizational and planning skills; ability to influence and negotiate professionally at various levels within the project team and with external partners while maintaining positive working relationships.
Sr. Manager/Associate Director, Regulatory Affairs Oruka Therapeutics IncSr. Manager/Associate Director, Regulatory AffairsMenlo Park, CA$161,000–$187,000 / yearOruka's mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice per year. This individual will work closely with cross-functional teams to provide regulatory guidance throughout product development, support health authority interactions, and help ensure the timely preparation and submission of high-quality regulatory applications.
NewSenior Manager, Regulatory Affairs Marea TherapeuticsSenior Manager, Regulatory AffairsSouth San Francisco, CA$180,000–$195,000 / yearReporting to the Director, Regulatory Affairs, the Senior Manager, Regulatory Affairs leads regulatory support for assigned programs to ensure sound regulatory planning and tactical implementation of US and international development strategies. 8+ years of drug development, including 5+ years of regulatory affairs experience in the Biotech/Pharmaceutical industry strongly preferred; experience in cardiometabolic/cardiovascular or endocrinology therapeutic areas is a plus.
Associate Director, Regulatory Affairs Iovance Biotherapeutics IncAssociate Director, Regulatory AffairsSan Carlos, CARemote$170,000–$200,000 / yearCollaborates closely with functional leaders to 1) create the optimal development path for Iovance product candidates, 2) negotiate optimal development paths within cross-functional teams and with health authorities, 3) execute clinical-regulatory development plans on-time and while managing all identified risks. Mental: Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to manage work-related stress; ability to manage multiple priorities simultaneously; and ability to meet deadlines.
Regulatory Affairs Associate Jess BusheyRegulatory Affairs AssociateMountain View, California$80,000Ultimate Staffing Services is actively seeking a dedicated and detail-oriented Regulatory Affairs Associate to join a reputable medical device manufacturer. Coordinate, prepare, compile, and maintain regulatory documentation for local and regional registration, license renewal, and product submissions.
Director, Regulatory Affairs Calico Life Sciences LLCDirector, Regulatory AffairsSouth San Francisco, CA$275,000–$280,000 / yearPosition Responsibilities: Accountable to develop and execute the world-wide regulatory strategy for assigned programs (from IND-enabling to clinical proof-of-concept and beyond), which may include programs that are first-in-class, where no or limited FDA guidance exists, that have an external business partner, and where there are multiple indications. Calico's highly innovative technology labs, its commitment to curiosity-driven discovery science, and, with academic and industry partners, its vibrant drug-development pipeline, together create an inspiring and exciting place to catalyze and enable medical breakthroughs.
Sr. Manager, Regulatory Affairs Vaxcyte IncSr. Manager, Regulatory AffairsSan Carlos, CA$183,000–$194,000 / yearEssential Functions: Represent Regulatory Affairs in various internal cross-functional project teams, improvement initiatives and providing regulatory positions on various CMC related topics. Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked.