NewSenior Program Director, Commercial Regulatory Affairs - Contract TalentBurst, Inc.Senior Program Director, Commercial Regulatory Affairs - ContractSouth San Francisco, CA$120–$128.78 / hourExample Duties and ResponsibilitiesPRC Leadership: Lead/chair PRCs and effectively collaborate with cross-functional internal groups and external advertising agencies; acting as the decision-maker for PRCs in the assigned therapeutic or business area. 4 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.
NewSenior Program Director, Commercial Regulatory Affairs JouléSenior Program Director, Commercial Regulatory AffairsSouth San Francisco, CA$120–$122.40 / hourSystem One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. Lead Program Review Committees (PRCs) independently, managing complex product launches and cross-functional activities.
NewDirector of Regulatory Affairs and Policy SupplyBank.orgDirector of Regulatory Affairs and PolicyOakland, CA$115,000–$130,000 / yearThrough partnerships with global supply chains and community organizations, SupplyBank.org provides a highly cost-effective and scalable mechanism for bulk purchasing and efficiently distributing necessary health, education, and emergency supplies to children, families, and communities that need them throughout California. Of the total 100 acres, more than 80 will be revitalized park spaces, infrastructure improvements and nature based solutions to restore tidal wetlands, habitat, flood management and increase public enjoyment of the Bay Trail and parklands.
Director of Regulatory Affairs Epia NeuroDirector of Regulatory AffairsAlameda, CaliforniaAs a Director of Regulatory Affairs you will report to the Chief Executive Officer and be responsible for owning the regulatory strategy and execution end-to-end from early FDA engagement through IDEs and PMA submission and approval, and commercialization. We’re looking for a Director of Regulatory Affairs for our office in Alameda, California who wants to lead, develop and execute the regulatory strategy for Epia Neuro’s Class III implantable neurotechnology.
NewDirector of Regulatory Affairs and Communication Contra Costa CountyCADirector of Regulatory Affairs and CommunicationMartinez, CA$147,558.98–$179,358.86 / yearThe Director of Regulatory Affairs and Communication (RAC) at Contract Costa Health Plan (CCHP or "Plan") is a senior leadership role responsible for leading regulatory oversight, agency communications, Policy Management Program, regulatory audit support, and enterprise regulatory strategy. This role serves as the primary liaison with state and federal regulators, including the California Department of Health Care Services (DHCS), Department of Managed Health Care (DMHC), and Centers for Medicare & Medicaid Services (CMS).
Senior Director, Head of Early Development Regulatory Affairs Revolution MedicinesSenior Director, Head of Early Development Regulatory AffairsRedwood City, CaliforniaLead global regulatory strategy from candidate selection through end-of-Phase 2. Shape early clinical development strategy by providing regulatory leadership on dose-finding approaches and indication selection that enable accelerated and differentiated development pathways and position asset for global registration and Health Authority Engagement. The company’s RAS(ON) inhibitors daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor; and RMC-5127, a RAS(ON) G12V-selective inhibitor, are currently in clinical development.
Senior Director, Head of Early Development Regulatory Affairs Revolution Medicines IncSenior Director, Head of Early Development Regulatory AffairsRedwood City, CA$244,000–$305,000 / yearLead global regulatory strategy from candidate selection through end-of-Phase 2. Shape early clinical development strategy by providing regulatory leadership on dose-finding approaches and indication selection that enable accelerated and differentiated development pathways and position asset for global registration and Health Authority Engagement. The company's RAS(ON) inhibitors daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor; and RMC-5127, a RAS(ON) G12V-selective inhibitor, are currently in clinical development.
NewSenior Program Director, Commercial Regulatory Affairs IT EngagementsSenior Program Director, Commercial Regulatory AffairsSouth San Francisco, CA$100–$100Role: Senior Clinical Program Director, Commercial Regulatory Affairs (Contract role)Location: San Francisco, CAPosition SummaryCommercial 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 Client'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.).
Director/Senior Director, Regulatory Affairs SepternaDirector/Senior Director, Regulatory AffairsSouth San Francisco, CA$235,000–$285,000 / yearSepterna is a biotechnology company based in South San Francisco, CA on a mission to develop life-changing medicines for patients with the vision to become the industry-leading G protein-coupled receptor (GPCR)-focused drug discovery company. To join our ambitious team, be prepared to bring your real self to work every day; grow and learn from a talented team of drug hunters, scientists, and business professionals; and contribute your passion, creativity, and energy to accomplish our mission.
Associate Director, Regulatory Affairs Advertising and Promotion Mirum PharmaceuticalsAssociate Director, Regulatory Affairs Advertising and PromotionFoster City, CaliforniaManage 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). 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.
NewSenior Program Director, Commercial Regulatory Affairs Software Guidance & AssistanceSenior Program Director, Commercial Regulatory AffairsSouth San Francisco, CA$47.37–$127.86 / hourResponsibilities : 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.).
Director, Regulatory Affairs, Global Investigations and Enforcement Competition Google LLCDirector, Regulatory Affairs, Global Investigations and Enforcement CompetitionMountain View, CAEvaluate potential or emerging internal and external risk and proactively undertake and strategically manage affirmative litigation or other steps to address that risk and increase Alphabet's resilience to risk. GSU grants are not guaranteed, are discretionary, are subject to approval by the Alphabet Inc. board of directors or its delegate, the terms of the relevant Alphabet Inc. stock plan, and your grant agreement.
NewSenior Program Director (Commercial Regulatory Affairs, Fully Remote) Dawar Consulting, Inc.Senior Program Director (Commercial Regulatory Affairs, Fully Remote)South San Francisco, CARemoteYou will lead Promotional Review Committees (PRCs), review and approve advertising and promotional materials, and partner closely with Marketing, Medical Affairs, Legal, and Compliance to ensure FDA‑compliant communications. Our client, a world leader in biotechnology and life sciences, is seeking a "Senior Program Director, Commercial Regulatory Affairs".
Associate Director, Global Regulatory Affairs Clinical Strategy - Job ID: 1961 Ascendis PharmaAssociate Director, Global Regulatory Affairs Clinical Strategy - Job ID: 1961Palo Alto, CA$185,000–$205,000Contributes to the development of global clinical and regulatory plans and strategies, identifies and proposes risk mitigation strategies, and influences project teams and sub teams across international site locations. Do you want to be part of building a fully integrated biopharmaceutical company together with a team of highly skilled colleagues who are passionate about developing best-in-class therapeutics that address significant unmet medical needs?
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.
Associate Director, Regulatory Affairs Project Planning & Coordination Acadia Pharmaceuticals IncAssociate Director, Regulatory Affairs Project Planning & CoordinationSan Francisco, CA$154,000–$193,000 / yearWe are developing the next wave of therapeutic advancements with a robust and diverse pipeline that includes mid- to late-stage programs in Alzheimer's disease psychosis and Lewy body dementia psychosis, along with earlier-stage programs that address other underserved patient needs. The Associate Director, Regulatory Affairs Project Planning & Coordination is responsible for developing, implementing, and monitoring project plans and best practices that facilitate how the Global Regulatory Affairs department executes its strategic and functional goals.
NewSenior 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.
NewSenior 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.
NewSenior Program Director, Commercial Regulatory Affairs TalentBurst, Inc.Senior Program Director, Commercial Regulatory AffairsSouth San Francisco, CA$120–$128.78 / hourExample Duties and ResponsibilitiesPRC Leadership: Lead/chair PRCs and effectively collaborate with cross-functional internal groups and external advertising agencies; acting as the decision-maker for PRCs in the assigned therapeutic or business area. 4 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.
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).
Director, CMC Regulatory Affairs Vir Biotechnology IncDirector, CMC Regulatory AffairsSan Francisco, CA$195,500–$272,500 / yearVir Biotechnology is seeking an a highly motivated, self-driven and enthusiastic Director of Regulatory CMC accountable for ensuring all assigned products have a successful regulatory CMC strategy for clinical development and commercialization. Manage CMC regulatory changes throughout the product life cycle, including support for relevant quality systems related to change control, discrepancy management, as well as Health Authority inspection support (as applicable).
NewDirector, CMC Regulatory Affairs Vir BiotechnologyDirector, CMC Regulatory AffairsSan Francisco, CA$195,500–$272,500 / yearVir Biotechnology is seeking an a highly motivated, self-driven and enthusiastic Director of Regulatory CMC accountable for ensuring all assigned products have a successful regulatory CMC strategy for clinical development and commercialization. Manage CMC regulatory changes throughout the product life cycle, including support for relevant quality systems related to change control, discrepancy management, as well as Health Authority inspection support (as applicable).
Director, Regulatory Affairs (US Filing Lead) Revolution MedicinesDirector, Regulatory Affairs (US Filing Lead)Redwood City, CaliforniaThe company’s RAS(ON) inhibitors daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor; and RMC-5127, a RAS(ON) G12V-selective inhibitor, are currently in clinical development. Degree in life sciences, pharmacy, medicine, or related fields with a minimum of 12 years in the pharmaceutical/biotech industry or relevant work experience and a minimum of 8 years in Regulatory Affairs including a regulatory strategy role.
Director, Regulatory Affairs US Filing Lead Revolution Medicines IncDirector, Regulatory Affairs US Filing LeadRedwood City, CA$211,000–$264,000 / yearThe company's RAS(ON) inhibitors daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor; and RMC-5127, a RAS(ON) G12V-selective inhibitor, are currently in clinical development. Required Skills, Experience and Education: Degree in life sciences, pharmacy, medicine, or related fields with a minimum of 12 years in the pharmaceutical/biotech industry or relevant work experience and a minimum of 8 years in Regulatory Affairs including a regulatory strategy role.
Director, Regulatory Affairs - US Filing Lead Revolution Medicines IncDirector, Regulatory Affairs - US Filing LeadRedwood City, CA$211,000–$264,000 / yearThe company's RAS(ON) inhibitors daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor; and RMC-5127, a RAS(ON) G12V-selective inhibitor, are currently in clinical development. Required Skills, Experience and Education: Degree in life sciences, pharmacy, medicine, or related fields with a minimum of 12 years in the pharmaceutical/biotech industry or relevant work experience and a minimum of 8 years in Regulatory Affairs including a regulatory strategy role.
Director, Regulatory Affairs - US Filing Lead Revolution MedicinesDirector, Regulatory Affairs - US Filing LeadRedwood City, CaliforniaThe company’s RAS(ON) inhibitors daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor; and RMC-5127, a RAS(ON) G12V-selective inhibitor, are currently in clinical development. Degree in life sciences, pharmacy, medicine, or related fields with a minimum of 12 years in the pharmaceutical/biotech industry or relevant work experience and a minimum of 8 years in Regulatory Affairs including a regulatory strategy role.
NewSenior 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.).
Director, Regulatory Affairs & Market Development Weave Grid Inc.Director, Regulatory Affairs & Market DevelopmentSan Francisco, CA$138,600–$198,000 / yearIdentify, monitor, and prioritize high-leverage regulatory proceedings, legislative developments, utility planning processes, and market design initiatives relevant to transportation electrification, managed charging, VPPs, DER flexibility, rate design, distribution planning, DSM, and grid modernization. You will work closely with Business Development, ClientSuccess, Product, Marketing, Legal, and executive leadership to ensure WeaveGrid is positioned to win in priority markets and help utilities unlock the full grid value of EVs and other distributed energy resources.
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.
Director Regulatory Affairs - Cardiac Intuitive Surgical IncDirector Regulatory Affairs - CardiacSunnyvale, CAThis role is a Director-level Regulatory Affairs leader, who will work with business unit leaders, clinical teams, reimbursement teams to define and execute global cardiac regulatory strategy, leads a cross-functional team leveraging regional teams and programs, ensures competitive market access, and represents the organization in senior regulatory and industry external facing activities. Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government's licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan ("TCP") (note: typically adds 2 weeks to the hiring process).
NewDirector, Regulatory Affairs Advertising & Promotion Acadia Pharmaceuticals IncDirector, Regulatory Affairs Advertising & PromotionSouth San Francisco, CA$193,400–$241,800 / yearThe position partners closely with cross-functional teams to support the timely approval and distribution of promotional and disease state materials, serves as the primary liaison with the FDA''s Office of Prescription Drug Promotion (OPDP) for advertising and promotional submissions, and contributes to labeling strategies for regulatory submissions across Acadia''s product portfolio. We are developing the next wave of therapeutic advancements with a robust and diverse pipeline that includes mid- to late-stage programs in Alzheimer's disease psychosis and Lewy body dementia psychosis, along with earlier-stage programs that address other underserved patient needs.
NewExecutive Director, Regulatory Affairs CMC AllakosExecutive Director, Regulatory Affairs CMCRedwood City, CaliforniaThey will: -Lead teams with regulatory CMC responsibility for support of development, registration and life cycle support, and CMC regulatory strategy for United States and EU.-Partner with regulatory support functions-Partner with Quality, Manufacturing, Process Development, and Supply Chain-Be the key interface between the Regulatory and the Technical Operations functions. Leads 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.
Director, Regulatory Affairs Global Filing Lead Revolution Medicines IncDirector, Regulatory Affairs Global Filing LeadRedwood City, CA$211,000–$264,000 / yearThe company's RAS(ON) inhibitors daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor; and RMC-5127, a RAS(ON) G12V-selective inhibitor, are currently in clinical development. Required Skills, Experience and Education: Degree in life sciences, pharmacy, medicine, or related fields with a minimum of 12 years in the pharmaceutical/biotech industry or relevant work experience and a minimum of 8 years in Regulatory Affairs including a regulatory strategy role.
Director, Regulatory Affairs (Global Filing Lead) Revolution MedicinesDirector, Regulatory Affairs (Global Filing Lead)Redwood City, CaliforniaThe company’s RAS(ON) inhibitors daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor; and RMC-5127, a RAS(ON) G12V-selective inhibitor, are currently in clinical development. Degree in life sciences, pharmacy, medicine, or related fields with a minimum of 12 years in the pharmaceutical/biotech industry or relevant work experience and a minimum of 8 years in Regulatory Affairs including a regulatory strategy role.
Director, Regulatory Affairs Nurix Therapeutics IncDirector, Regulatory AffairsBrisbane, 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.
Associate Director, Regulatory Affairs Strategy, Hematology Oncology Nurix Therapeutics IncAssociate Director, Regulatory Affairs Strategy, Hematology OncologyBrisbane, CAThe successful candidate will be a core member of the Regulatory team and will be responsible for helping build and execute on global regulatory strategy, objectives, policies and programs pertaining to development and future marketing of products for guiding and executing upon regulatory strategy of 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.
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.
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.
Associate Regulatory Affairs Strategy Director (Oncology) Exelixis IncAssociate Regulatory Affairs Strategy Director (Oncology)Alameda, CA$195,000–$277,500 / yearEDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS: Education/Experience: Bachelor's degree in related discipline and a minimum of eleven years of related experience; or, Master's degree in related discipline and a minimum of nine years of related experience; or, PhD degree in related discipline and a minimum of five years of related experience; or, Equivalent combination of education and experience. Experience/The Ideal for Successful Entry into Job: Knowledge/Skills: Develops and manages plans within established timelines and balances commitments to complete multiple activities and achieve results.
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 CMC Mirum PharmaceuticalsSenior Director, Regulatory Affairs CMCFoster City, CaliforniaThe 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 (on-site) Abbott LaboratoriesAssociate Director, Regulatory Affairs (on-site)Alameda, CA$148,700–$297,300 / yearThe individual will play a critical role in anticipating and influencing evolving regulations and guidance, lead complex management change initiatives, interface with outside regulatory agencies and trade associations, and advise executive management with strategic insights and key regulatory metrics. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines.
Associate Director, Regulatory Affairs (on-site) AbbottAssociate Director, Regulatory Affairs (on-site)Alameda, CaliforniaThe individual will play a critical role in anticipating and influencing evolving regulations and guidance, lead complex management change initiatives, interface with outside regulatory agencies and trade associations, and advise executive management with strategic insights and key regulatory metrics. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines.
Associate Director, Global Regulatory Affairs Project Management Revolution Medicines IncAssociate Director, Global Regulatory Affairs Project ManagementRedwood City, CA$186,000–$233,000 / yearDrive the operational planning, coordination, and tracking of new drug marketing application submission activities across cross-functional Filing Teams (including Regulatory, Medical Writing, Nonclinical, Clinical, Safety, Biostatistics, CMC / Pharmaceutical Development and Manufacturing, etc. and external consultants), supporting the Global Filing Lead's strategic vision. The company's RAS(ON) inhibitors daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor; and RMC-5127, a RAS(ON) G12V-selective inhibitor, are currently in clinical development.
Associate Director, Global Regulatory Affairs Project Management Revolution MedicinesAssociate Director, Global Regulatory Affairs Project ManagementRedwood City, CaliforniaDrive the operational planning, coordination, and tracking of new drug marketing application submission activities across cross-functional Filing Teams (including Regulatory, Medical Writing, Nonclinical, Clinical, Safety, Biostatistics, CMC / Pharmaceutical Development and Manufacturing, etc. and external consultants), supporting the Global Filing Lead’s strategic vision. The company’s RAS(ON) inhibitors daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor; and RMC-5127, a RAS(ON) G12V-selective inhibitor, are currently in clinical development.
Director Multiport Regulatory Affairs Intuitive Surgical IncDirector Multiport Regulatory AffairsSunnyvale, CACertain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government's licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan ("TCP") (note: typically adds 2 weeks to the hiring process). U.S. Export Controls Disclaimer: In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employees who are nationals from countries currently on embargo or sanctions status.
Sr. Director, Regulatory Affairs BridgeBio Pharma IncSr. Director, Regulatory AffairsSan Francisco, CA$285,000–$320,000 / yearThe ideal candidate brings deep Regulatory CMC expertise, strong cross-functional leadership skills, demonstrated experience with global and ROW filings (e.g., MENA, LATAM, APAC), and practical fluency leveraging AI-enabled and digital tools to improve regulatory workflows and deliverables. Demonstrated experience leading complex global regulatory submissions, including Rest of World (ROW) regions (e.g., MENA, LATAM, APAC), with ability to navigate regional regulatory requirements and coordinate cross-regional filing strategies.
Director, Regulatory Affairs Nova Pneuma IncDirector, Regulatory AffairsFremont, CAManage and prepare post-market filings and product safety reports (e.g., Annual Reports, DSUR, PSUR, REMS Annual Report, Supplements, Technical Documentation File lifecycle maintenance, responses to regulatory information requests). Experience with commercial products, Drug Safety/ Pharmacovigilance (adverse event reporting, DSUR, PSUR, REMS Annual Reports and audits), product approval process, and post-market surveillance.
NewSenior 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.
Senior Director & Therapeutic Area Head, Regulatory Affairs Revolution MedicinesSenior Director & Therapeutic Area Head, Regulatory AffairsRedwood City, CaliforniaThe company’s RAS(ON) inhibitors daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor; and RMC-5127, a RAS(ON) G12V-selective inhibitor, are currently in clinical development. Degree in life sciences, pharmacy, medicine, or related fields with a minimum of 12 years in the pharmaceutical/biotech industry or relevant work experience and a minimum of 8 years in Regulatory Affairs including regulatory strategy and leadership roles.