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.
NewLEGISLATIVE AND REGULATORY AFFAIRS DIRECTOR AT HOUSING CALIFORNIA Axis Talent PartnersLEGISLATIVE AND REGULATORY AFFAIRS DIRECTOR AT HOUSING CALIFORNIASacramento, CAWe bring together a diverse, cross-sector network to prevent and end homelessness, increase the supply of safe, stable, affordable homes, and reverse the legacy of systemic racial and economic inequities by building power among the people most impacted by housing injustice in partnership with cross-sector partners, shaping the narrative, and advocating for the passage of transformative statewide policy solutions. The position is expected to participate in regular travel (mostly in California) including the following engagements: twice yearly Board of Directors meetings (sometimes held in Sacramento); annual 2-3 day staff retreat; annual 3-day Housing California conference (often in Sacramento); annual 2-3-day statewide RUN summit (sometimes in Sacramento); plus various conferences or in-person partner meetings, based on need and interest.
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.
NewAssociate Director, State Government Affairs - Remote Agios PharmaceuticalsAssociate Director, State Government Affairs - RemoteSan Diego, CARemote$153,541–$230,312 / yearThe current base salary range for this position is expected to be between $153,541 and $230,312 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators. Our team’s proven track record of executional excellence, combined with our depth of expertise and dedication, enables us to develop innovative medicines that reflect the priorities of rare disease communities.
NewSpecialist, Regulatory Affairs John Paul Mitchell SystemsSpecialist, Regulatory AffairsSanta Clarita, CA$39.61–$43.27 / hourWe’ve been serving the professional beauty industry with salon-quality hair care products, styling tools and professional hair color through our family of brands including Paul Mitchell, MITCH, Awapuhi Wild Ginger, Tea Tree, Paul Mitchell Tools, Neuro, The Demi, Paul Mitchell the Color, Blonde, and Color XG. Reporting to the Director, Regulatory Affairs, the Regulatory Affairs Specialist will be responsible for supporting registration/regulatory needs to maintain and further develop the regulatory capability, to support global innovation projects, and to address business issues to meet business goals.
NewSenior Manager, Medical Affairs Operations - Remote Agios PharmaceuticalsSenior Manager, Medical Affairs Operations - RemoteLos Angeles, CARemote$131,035–$196,553 / yearManage the execution of Agios’ patient advocacy conference plans for PK deficiency, thalassemia, and sickle cell disease; participate in cross-functional planning meetings; obtain compliance approval for related materials; and attend virtual and in-person conferences, when needed. Provide operational and project management support to the US patient advocacy team, ensuring smooth day-to-day coordination across priorities, stakeholders, and deliverables, and flex to support various other functions within Medical Affairs as needs arise.
NewWater Quality/Regulatory Affairs Supervisor Palmdale Water DistrictWater Quality/Regulatory Affairs SupervisorPalmdale, CA$75.78–$87.87 / hourParticipate in development of improved water treatment processes and review monitoring programs related to water supply, distribution and storage; recommend changes in monitoring programs, treatment methods or process control. To plan, organize, direct, and supervise water quality laboratory operations and related regulatory compliance activities within the Operations Department; and to perform a variety of technical tasks relative to assigned area of responsibility.
NewProject Manager, Regulatory Affairs (Clinical and CMC) Mitchell MartinProject Manager, Regulatory Affairs (Clinical and CMC)Encinitas, CARemote$58.80–$84 / hourBy applying for this job, you agree to receive AI-generated calls, text messages, and/or emails from Mitchell Martin Inc and its affiliates and contracted partners at various frequency through traditional and automated methods. Join our team as a Project Manager in Regulatory Affairs, focusing on Clinical and CMC.
NewDirector, Regulatory Strategy (Pediatrics) - Remote Agios PharmaceuticalsDirector, Regulatory Strategy (Pediatrics) - RemoteSan Jose, CARemote$183,549–$275,324 / yearThe current base salary range for this position is expected to be between $183,549 and $275,324 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators. This individual will lead cross-functional teams in preparing and overseeing development of compliant, high quality, nonclinical and clinical global regulatory submissions to support development, registration, or life cycle management activities.
Sr Manager of Quality & Regulatory Michael Page USASr Manager of Quality & RegulatoryWest Hollywood, CA$120,000–$145,000 / yearFull timeOversee product testing processes, including sample coordination, protocols, vendor quotes, and method validation to ensure accuracy, reliability, and regulatory compliance of testing procedures. We are seeking a highly detail-oriented QA & Regulatory Sr Manager to oversee product compliance, safety, and quality systems across the full product lifecycle.
NewField Medical Director, South Central ImmunityBioField Medical Director, South CentralCulver City, CAWhen assigned, deliver scientific and value presentations to health care decision makers (HCDMs), including, but not limited to, Managed Care Organizations (MCOs), specialty pharmacy providers (SPPs), group purchasing organizations (GPOs), pharmaceutical benefit managers (PBMs), and integrated delivery networks (IDNs).Education & Experience Advanced medical/scientific/clinical degree (MD, DO, PhD, PharmD, NP, and PA preferred) with experience in the pharmaceutical industry or related healthcare field required. National Market (all markets unless identified as Premium)$214,000 (entry-level qualifications) to $235,000 (highly experienced) annuallyPremium Market (Premium markets include Los Angeles, San Diego, San Francisco, New York City, Chicago, & Boston)$223,000 (entry-level qualifications) to $245,000 (highly experienced) annuallyThe application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed.
NewAssociate Director, Scientific Communications & Publications - Remote Agios PharmaceuticalsAssociate Director, Scientific Communications & Publications - RemoteSan Jose, CARemote$153,000–$230,000 / yearOperating at the intersection of strategy and execution, this role partners closely with cross-functional colleagues and external experts to deliver high‑impact publications and scientific communications that advance both patient care and scientific dialogue. The current base salary range for this position is expected to be between $153,000 and $230,000 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators.
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.
NewAssociate Director/ Director, Patient Marketing - Remote Agios PharmaceuticalsAssociate Director/ Director, Patient Marketing - RemoteSan Diego, CARemote$183,549–$275,324 / yearThe current base salary range for this position at the Associate Director level is expected to be between $153,541 and $230,312 annualized and the current base salary range for this position at the Director level is expected to be between $183,549 and $275,324 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators. The Associate Director/Director, Patient Marketing will focus on developing and executing the patient strategy in preparation for the future launch of mitapivat, currently in development for sickle cell disease, a vastly underserved community.
NewMedical Director, Sickle Cell Disease, Clinical Development Agios PharmaceuticalsMedical Director, Sickle Cell Disease, Clinical DevelopmentLos Angeles, CA$221,600–$369,333 / yearThe current base salary range for this position is expected to be between $221,600 and $369,333 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators. Follow important developments and relevant trends in scientific literature and develop/maintain contracts with external experts to support understanding of the candidate drug effects and to gain strategic insights to the further development and placement of study and overall program.
Director of Regulatory Affairs Radiant Industries IncDirector of Regulatory AffairsEl Segundo, CACraft a modern regulatory strategy based in sound engineering principles with input from executives, our board of directors, and industry experts that brings the safest product to market the fastest. Portable nuclear power with rapid-deploy capability can replace similar-sized diesel generators and provide critical asset support for hospitals, data centers, remote sites, and military bases.
Executive Director of Regulatory Affairs - Obesity and Related Conditions Amgen IncExecutive Director of Regulatory Affairs - Obesity and Related ConditionsThousand Oaks, CA$255,302–$345,408 / yearIn 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: 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 a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Director of Regulatory Affairs Radiant IndustriesDirector of Regulatory AffairsEl Segundo, CaliforniaCraft a modern regulatory strategy based in sound engineering principles with input from executives, our board of directors, and industry experts that brings the safest product to market the fastest. . Portable nuclear power with rapid-deploy capability can replace similar-sized diesel generators and provide critical asset support for hospitals, data centers, remote sites, and military bases.
NewRegional Director - Anesthesiology - Vituity Practice Management - Emeryville VituityRegional Director - Anesthesiology - Vituity Practice Management - EmeryvilleEmeryville, CA$275,000–$900,000 / yearCommit to creating and demonstrating inclusivity within Vituity including codesigning, building, and executing strategies, policies, and practices that cultivate equity, inclusion, and fair opportunity for all; demonstrating preparedness to educate, mitigate, coach, and address daily bias and exclusion in partnership with the site leadership. Accountable for ensuring meaningful integration occurs: Identify opportunities for practice line integration to ensure the quality and efficiency of patient care delivery across the acute care continuum; assist with new service line startups; engage regularly with integrated site RDs.
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).
Director of Environmental Regulatory Affairs & Restoration Resource Environmental Solutions LLCDirector of Environmental Regulatory Affairs & RestorationSacramento, CA$148,085–$174,000 / yearIn this role, you will facilitate coordination across offices and disciplines, share regulatory updates and best practices, support staff training, and partner with Government Affairs and regional leadership on policy developments, draft legislation, and emerging issues that may affect RES business lines and environmental markets. This position is ideal for a seasoned regulatory leader who brings deep expertise in environmental permitting, restoration and mitigation strategy, agency coordination, technical review, staff development, and cross-functional project leadership.
NewPlant Quality Manager CONAGRAPlant Quality ManagerOakdale, CA$109,000–$159,000Lead food safety and quality programs, including Hazard Analysis and Critical Control Points, Safe Quality Food certification, recall programs, environmental monitoring, and pest control programs. Reporting to the Director, Food Safety Quality and Regulatory Affairs, you will lead food safety and quality programs at our Oakdale, California manufacturing facility, a local producer of Hunt’s tomato products.
Director of Licensing & Regulatory Affairs (SMR / MMR Programs) BaRupOn LLCDirector of Licensing & Regulatory Affairs (SMR / MMR Programs)Irvine, CABaRupOn LLC is seeking a highly experienced Director of Licensing & Regulatory Affairs to lead all regulatory strategy, licensing execution, and compliance activities for its Small Modular Reactor (SMR) and Micro Modular Reactor (MMR) programs in the United States. The ideal candidate brings deep, direct NRC engagement experience, a thorough command of U.S. nuclear regulatory frameworks, and the leadership ability to build and manage a high-performing regulatory team in a fast-moving, mission-driven environment.
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.
NewDialysis Facility Administrator U.S. Renal CareDialysis Facility AdministratorSan Diego, CA$110,947–$166,421Additionally, if the nursing requirements listed below are not met, an individual may be placed in the Administrator role without them; however, in the absence of these qualifications, there must be a designated Registered Supervising Nurse at the clinic who does possess these qualifications: Must be full-time employee of the Company and available to clinic staff during time clinic is open. · Continuously monitor to ensure that a safe and sanitary physical environment is maintained throughout the facility; that all equipment is maintained and functions properly; and that adequate and appropriate inventory levels of all supplies are available and used correctly.
Director, Regulatory Affairs Mapp BiopharmaceuticalDirector, Regulatory AffairsSan Diego, CARemote$130,000–$250,000 / yearThe Early Research and Development Group (ERDG) and the Advanced Research and Development Group (ARDG) at Mapp Biopharmaceutical are responsible for the execution of high quality Research and Development activities to ensure the achievement of a robust portfolio through CMC, Nonclinical, Regulatory, Project Management, and Clinical activities consistent with Mapp's product development objectives. Mapp Biopharmaceutical, Inc. "Mapp" is a San Diego based, innovative biopharmaceutical company focused on addressing unmet medical needs through the development of life-saving monoclonal antibody treatment options to combat a variety of neglected and tropical infectious diseases, and in support of biodefense programs.
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.).
Associate Director, Regulatory Affairs Global Regulatory Advertising and Promotion Arrowhead Pharmaceuticals IncAssociate Director, Regulatory Affairs Global Regulatory Advertising and PromotionPasadena, CA$180,000–$200,000 / yearProvide regulatory review and strategic guidance for promotional (branded and disease state) and medical communications for US prescription drug products across multiple channels, including digital, social media, websites, emails, print, speaker programs, video testimonials, scientific congresses, and field communications, among others. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates.
NewAssociate Director, Regulatory Affairs (Global Regulatory Advertising and Promotion) Arrowhead PharmaceuticalsAssociate Director, Regulatory Affairs (Global Regulatory Advertising and Promotion)Los Angeles, CA$180,000–$200,000 / yearProvide regulatory review and strategic guidance for promotional (branded and disease state) and medical communications for US prescription drug products across multiple channels, including digital, social media, websites, emails, print, speaker programs, video testimonials, scientific congresses, and field communications, among others. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates.
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.
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, 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?
Legislative and Regulatory Affairs Director at Housing California Axis Talent PartnersLegislative and Regulatory Affairs Director at Housing CaliforniaSacramento, CaliforniaWe bring together a diverse, cross-sector network to prevent and end homelessness, increase the supply of safe, stable, affordable homes, and reverse the legacy of systemic racial and economic inequities by building power among the people most impacted by housing injustice in partnership with cross-sector partners, shaping the narrative, and advocating for the passage of transformative statewide policy solutions. The position is expected to participate in regular travel (mostly in California) including the following engagements: twice yearly Board of Directors meetings (sometimes held in Sacramento); annual 2-3 day staff retreat; annual 3-day Housing California conference (often in Sacramento); annual 2-3-day statewide RUN summit (sometimes in Sacramento); plus various conferences or in-person partner meetings, based on need and interest.
NewSenior Program Director (Commercial Regulatory Affairs, Fully Remote) Dawar ConsultingSenior Program Director (Commercial Regulatory Affairs, Fully Remote)South San Francisco, CaliforniaRemoteYou 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".
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.
Senior Director, Regulatory Affairs Contineum TherapeuticsSenior Director, Regulatory AffairsSan Diego, CARemote$240,000–$265,000The Senior Director of Regulatory Affairs leads global regulatory activities and manages personnel for IND/CTA preparations, meetings, and maintenance to support new and ongoing development programs. Contineum Therapeutics (Nasdaq: CTNM) is a clinical-stage biopharmaceutical company pioneering novel, oral small molecule therapies for NI&I indications with significant unmet need.
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).
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.
Associate Director, Regulatory Affairs Project Planning & Coordination Acadia Pharmaceuticals IncAssociate Director, Regulatory Affairs Project Planning & CoordinationSan Diego, 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.
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.
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 Labeling Arrowhead Pharmaceuticals IncDirector, Regulatory Affairs LabelingSan Diego, CA$210,000–$230,000 / yearManage development, review, approval, and version control of labeling documents, including Target Product Labeling, Core Labeling (e.g., Company Core Data Sheet [CCDS]), and Regional Labeling (e.g., USPI, EU SmPC), in a timely manner according to internal SOPs and external regulatory requirements. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates.