Sr. Regulatory Affairs Specialist JouléSr. Regulatory Affairs SpecialistMountain View, CA$55–$60 / hourSystem One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. Provide regulatory guidance to product teams, develop strategies for the U.S. and Canadian markets, and influence global regulatory strategies.
NewDirector Regulatory Affairs - CMC Clinical Dynamix, Inc.Director Regulatory Affairs - CMCSan Diego, CAResponsible for the regulatory CMC leadership of one or more commercial and development projects, including responsibility for regulatory strategy, IND/CTA preparation, maintenance and update activities, interaction with and preparation for key milestone meetings with regulatory agencies with focus on the CMC aspects. Extensive project regulatory leadership and expertise, specifically focused on the CMC aspects for small molecules, biologics, and/or gene therapies.
Project Manager (Lifesciences/Biotech- Medical affairs) Tanisha SystemsProject Manager (Lifesciences/Biotech- Medical affairs)Foster City, CAFull timeThe role will serve as the primary liaison between stakeholders, Medical Affairs, business teams, IT teams, vendors, and delivery partners to ensure successful planning and execution of projects and operational initiatives. Proven track record managing enterprise application and business transformation projects; Ability to manage scope, schedules, resources, budgets, risks, and dependencies.
NewQuality Systems & Regulatory Manager JobotQuality Systems & Regulatory ManagerLos Angeles, CA$90,000–$120,000 / yearInformation collected and processed as part of your Jobot candidate profile, and any job applications, resumes, or other information you choose to submit is subject to Jobot's Privacy Policy, as well as the Jobot California Worker Privacy Notice and Jobot Notice Regarding Automated Employment Decision Tools which are available at jobot.com/legal. They’re looking for a tech-savvy and detail-oriented Quality Systems & Regulatory Manager to lead food safety systems, labeling accuracy, customer compliance documentation, and cross-functional audit readiness.
NewMedical Science Liaison, Oncology (Northern CA, OR, WA, MT, ID) Jazz PharmaceuticalsMedical Science Liaison, Oncology (Northern CA, OR, WA, MT, ID)San Francisco, CARemote$160,000–$240,000 / yearThe successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan. Consistently acts to enhance Jazz Pharmaceuticals’ image as an advocate of medical advancement by using knowledge of product, disease state and pipeline products to engage healthcare providers in meaningful scientific exchange of information.
NewPrincipal Engineer, Design Assurance New World Medical, Inc.Principal Engineer, Design AssuranceRANCHO CUCAMONGA, CA$138,000–$150,000 / yearThe role partners cross-functionally with R&D, Engineering, Regulatory Affairs, Manufacturing, Clinical, Operations, and other functions to ensure appropriate application of design controls, risk management, verification and validation, and Quality Management System requirements. The Principal Engineer, Quality – Design Assurance serves as a quality engineering technical leader supporting new product development, clinical development, design transfer, and sustaining activities throughout the product lifecycle.
NewQuality Assurance Specialist JouléQuality Assurance SpecialistOntario, CASystem One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. Experience within Consumer Packaged Goods (CPG), Cosmetics, OTC, Medical Device, or related industries.
NewSenior Medical Science Liaison Movement Disorders - West LundbeckSenior Medical Science Liaison Movement Disorders - WestLos Angeles, CARemote$180,000–$220,000 / yearStrategic Scientific Engagement & Insight Generation: Establishes and sustains deep, longitudinal scientific partnerships with Key Opinion Leaders (KOLs), Centers of Excellence, and investigators working in multiple system atrophy. This role serves as a strategic pre-launch scientific partner to external experts and internal stakeholders, generating high-quality, actionable insights that inform evidence strategy, disease education, portfolio decision-making, and launch readiness.
Vice President, Medical Affairs, Clinical Operations & Regulatory Affairs Dendreon CorporationVice President, Medical Affairs, Clinical Operations & Regulatory AffairsSeal Beach, CaliforniaThis executive role ensures alignment across scientific communications, product lifecycle management, clinical development, and regulatory strategy to support the successful development, approval, and commercialization of the company's products and contract manufacturing services (CMS) pipeline. Develop and maintain strategic relationships with physicians, investigators, Key Opinion Leaders (KOLs), healthcare providers, and scientific experts to support clinical development, evidence generation, product adoption, and medical education initiatives.
Manager, Regulatory Affairs, Regulatory PMO Google LLCManager, Regulatory Affairs, Regulatory PMOMountain View, CAOversee and lead a team partnering with legal counsel, product teams, and other cross-functional stakeholders to drive strategy, share information, and implement program management principles across our largest and most complex matters (including litigation, internal investigations, and regulatory requests). Lead the development of project, program, and portfolio management methodologies, identifying opportunities for cross-organizational process improvement initiatives and knowledge management projects.
Regulatory Affairs Senior Director - Global Regulatory Leader - Oncology AmgenRegulatory Affairs Senior Director - Global Regulatory Leader - OncologyThousand Oaks, CaliforniaTo independently develop a comprehensive regulatory strategy for one or more high complexity programs, typically in late-stage development and/or with multiple indications, that takes into account worldwide regulatory requirements to drive product development, global registration, achievement and maintenance of desired regional labeling, and effective regulatory agency interactions. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
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.
Vice President, Regulatory And Head Of Regulatory Affairs Sagimet Biosciences IncVice President, Regulatory And Head Of Regulatory AffairsSan Mateo, CA$340,000–$370,000 / yearThis role will serve as the primary liaison with global regulatory authorities and involve close collaboration with Sagimet's cross-functional teams and external partners, to ensure the successful advancement of our clinical programs. Position Summary: The VP of Regulatory and Head of Regulatory Affairs will shape and execute regulatory strategies and lead and manage submissions to support clinical development and regulatory compliance for Sagimet.
Vice President, Regulatory and Head of Regulatory Affairs Sagimet Biosciences IncVice President, Regulatory and Head of Regulatory AffairsSan Mateo, CA$340,000–$370,000 / yearThis role will serve as the primary liaison with global regulatory authorities and involve close collaboration with Sagimets cross-functional teams and external partners, to ensure the successful advancement of our clinical programs. Oversee the companys external regulatory advisors, consultants and vendors to ensure that relevant regulatory advice is provided with respect to the companys development programs.
NewRegulatory Affairs Manager - Oncology and Regulatory Promotion Amgen IncRegulatory Affairs Manager - Oncology and Regulatory PromotionThousand Oaks, CAIn addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients.
Regulatory Affairs Specialist Nihon Kohden Orange MedRegulatory Affairs SpecialistSanta Ana, CA$80,000–$95,000 / yearCoordinates regulatory requests from Sales Offices and internal stakeholders, including Certificates to Foreign Governments (CFGs), Certificates of Free Sale, authentications, and other regulatory certificates or documentation. Ensures regulatory information for assigned products and markets is current and supports timely retrieval and presentation of documentation for internal stakeholders, regulatory authorities, audits, inspections, and other authorized requests.
Associate Director, Global Medical & Promotional Regulatory Affairs Jazz Pharmaceuticals PlcAssociate Director, Global Medical & Promotional Regulatory AffairsCARemote$160,000–$240,000 / yearThe Associate Director, Global Medical and Promotional Regulatory Affairs will be a member of Jazz Pharmaceuticals' Global Medical and Promotional Regulatory Affairs group and will be leading the promotional materials review activities; will be responsible for directing the regulatory aspects of internal and external communications, including advertising and promotional activities in the US; will provide insight, judgment and sound decisions on promotional and non-promotional programs and tactics for assigned products in oncology or assigned therapeutic area. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan.
NewVice President, Quality Assurance & Regulatory Affairs Nihon Kohden Orange MedVice President, Quality Assurance & Regulatory AffairsSanta Ana, CA$190,000–$230,000 / yearProvide regulatory leadership for Class I and Class II medical devices, including product classification, regulatory pathways, pre-market submissions, registrations, clearances, approvals, and post-market requirements. Ensure the Quality Management System effectively supports the full product lifecycle, including design and development, manufacturing, supplier management, production, distribution, servicing, and post-market activities.
Senior Regulatory Affairs Specialist - Pleasanton, CA Calyxo IncSenior Regulatory Affairs Specialist - Pleasanton, CAPleasanton, CA$145,000–$160,000 / yearRequirements: Master's degree with a minimum of 5 years of directly relevant regulatory affairs experience, or Bachelor's degree with a minimum of 8 years of directly relevant regulatory affairs experience, in the medical device, pharmaceutical, biotechnology, or in vitro diagnostics (IVD) industry, including experience with Class II or Class III electromechanical medical devices. In This Role, You Will: Prepare, author, and manage U.S. and international regulatory filings (including 510(k)s, letters to file, registrations/listings, and other regulatory submissions) with appropriate guidance for higher-risk or more complex issues, ensuring timely, high-quality deliverables.
Principle Regulatory Affairs Strategy Associate Sunrise Systems IncPrinciple Regulatory Affairs Strategy AssociateLake Forest, CA$79.71–$83.33 / hourThe Principle Regulatory Affairs Strategy Associate, reporting to the Senior Director of Regulatory Affairs (LLSI), is primarily responsible for setting or executing the regulatory strategy, leading and managing, acting as a strategist, ensuring local product registration and facilitating health registration approvals, and supporting the Senior Director during due diligence and integration activities for Business Development & Licensing projects. Coordinate regulatory activities, including product submissions, renewals, and updates, by liaising with plants, agents, and governmental authorities to ensure timely submissions and approvalsOversee promotional material approval for Alcon ME/KSA portfolio, ensuring ethical conduct and compliance with national and international laws, codes, and regulations.