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.
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 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.
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.
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.
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.
NewDocumentation Specialist Vaco LLCDocumentation SpecialistLos Angeles, CA$30–$35Determining compensation for this role (and others) at Vaco by Highspring depends upon a wide array of factors including but not limited to: the individual’s skill sets, experience and training; licensure and certification requirements; office location and other geographic considerations; other business and organizational needs. Vaco by Highspring values a diverse workplace and strongly encourages women, people of color, LGBTQ+ individuals, people with disabilities, members of ethnic minorities, foreign-born residents, and veterans to apply.
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.
NewRegional Director - Anesthesiology - Vituity Practice Management - Emeryville VituityRegional Director - Anesthesiology - Vituity Practice Management - EmeryvilleEmeryville, CACommit 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.
Senior Regulatory Affairs Associate Alcon IncSenior Regulatory Affairs AssociateLake Forest, CAAssociate, Regulatory Affairs Strategy (Professional Path) , reporting to the Senior Manager of Regulatory Affairs (LLSI), is primarily responsible for coordinating regulatory compliance for Alcon's product portfolio, managing local initiatives, and supporting business requests for product and regulatory information. Data requests to R&D for tender applications, one-off requests for country-specific technical information, maintenance of project status master slide deck for regional RA calls, drafting (not signing) explanation letters, and other administrative requirements for HA queries.
Sr. Associate II, Regulatory Affairs Strategy Alcon IncSr. Associate II, Regulatory Affairs StrategyIrvine, CAIn this role, you will develop strong scientific and technical product knowledge and serve as a key resource to country Regulatory Affairs associates by providing regulatory guidance and information. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an email to alcon.recruitment@alcon.com and let us know the nature of your request and your contact information.
Regulatory Affairs Associate Jess BusheyRegulatory Affairs AssociateMountain View, California$75,000–$95,000Coordinate and maintain regulatory documentation, including preparation for local and regional registrations, license renewals, and product submissions. This role is pivotal in ensuring compliance with various global regulations, including FDA 21 CFR 820, EN ISO 13485, and the European Medical Regulation (MDR).
Strategy and Operations Lead, Regulatory Affairs Google LLCStrategy and Operations Lead, Regulatory AffairsCAYou will also partner with teams across Google and Alphabet's Public Policy, Compliance, Legal, Engineering, Finance and product areas to support the handling of some of the most important issues for the company today. In this role, you will work closely with members of Regulatory Affairs and act as the central operations support for the department"s role in the broader regulatory lifecycle.
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.
Manager II, Regulatory Affairs Strategy Alcon IncManager II, Regulatory Affairs StrategyCA$105,000–$175,000 / yearYou will support regulatory strategy execution with a focus on medical device consumables and accessories within the Surgical franchise, partnering cross‑functionally to ensure alignment with evolving regulatory expectations. Our benefits program provides security for life events through life and disability insurance, supports savings for retirement, promotes good health and well-being and supports associates and their families during times of illness.
Associate Labeling Specialist - Regulatory Affairs Applied Medical Resources CorpAssociate Labeling Specialist - Regulatory AffairsRancho Santa Margarita, CA$71,000–$80,000 / yearThe Associate Labeling Specialist works cross-functionally to support labeling projects from design input through final approval, making this an ideal opportunity for professionals with a background in regulatory affairs, quality assurance, or technical writing in the medical device industry. Our unique business model, combined with our dedication to delivering the highest quality products, enables team members to contribute in a larger capacity than is possible in typical positions.
Regulatory Affairs Manager I Alcon IncRegulatory Affairs Manager ILake Forest, CAThe Manager I, Regulatory Affairs Strategy (Professional Path) ), reporting to the Senior Manager of Regulatory Affairs (LLSI), is primarily responsible for coordinating regulatory affairs activities, including product submissions, renewals, and updates, while ensuring compliance and competitive advantage. Collect and analyze regulatory intelligence for China to ensure product compliance and engage in industry associations like Advanced Medical Technology Association (AdvaMed) and Asia Pacific Medical Technology Association (APACMed).
NewSr. Associate II, Regulatory Affairs Strategy Alcon ResearchSr. Associate II, Regulatory Affairs StrategyLake Forest, CaliforniaIn this role, you will develop strong scientific and technical product knowledge and serve as a key resource to country Regulatory Affairs associates by providing regulatory guidance and information. You will support regulatory strategy execution with a focus on Retinamedical devices within the Surgical franchise, partnering cross‑functionally to ensure alignment with evolving regulatory expectations.
Senior Manager, Regulatory Affairs Strategy Alcon IncSenior Manager, Regulatory Affairs StrategyLake Forest, CAManager, Regulatory Affairs Strategy (Professional Path), 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. In this role, a typical day will include: A self-starter, assertive leader who will be accountable for the End-to-End regulatory support for the anterior/posterior ophthalmologic products including, but not limited to, new products, sustaining legacy products, and improvements to the product lines.
Regulatory Affairs & Compliance Analyst, Policies & Procedures CalOptimaRegulatory Affairs & Compliance Analyst, Policies & ProceduresOrange, CA$68,015–$108,824 / yearWe are hoping you will join us as a Regulatory Affairs & Compliance Analyst, Policies & Procedures and help shape the future of healthcare where you'll be an integral part of our OOC - Policies & Procedures team, helping to strive for excellence while we serve our member health with dignity, respecting the value and needs of each of our members through collaboration with our providers, community partners and local stakeholders. Bachelor's degree in health services administration, public health, public policy or related field PLUS 3 years of experience in the health care industry in a public or regulatory affairs role, including experience in policies and procedures development, required; an equivalent combination of education and experience sufficient to successfully perform the essential duties of the position such as those listed above may also be qualifying.
Principle Regulatory Affairs Strategy Associate Artech LLCPrinciple Regulatory Affairs Strategy AssociateLake Forest, CA$72–$75 / 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. Expectations / Responsibilities: A self-starter, assertive leader who will be accountable for the End-to-End regulatory support for the anterior/posterior ophthalmologic products including, but not limited to, new products, sustaining legacy products, and improvements to the product lines.
Director, Regulatory Affairs Strategy Alcon IncDirector, Regulatory Affairs StrategyLake Forest, CAAs a Director, Regulatory Affairs Strategy (Management Path) supporting Alcons Quality & Regulatory Affairs organization, this onsite role based at our Lake Forest, California main campus is responsible for developing and executing regulatory strategies to obtain and maintain product approvals across Alcons franchise portfolios. Primary responsibilities include providing strategic regulatory leadership across the product lifecycle, preparing and overseeing high-quality regulatory submissions, and serving as the primary liaison with global health authorities to support timely product approvals.
Regulatory Affairs Specialist II Envista Holdings CorpRegulatory Affairs Specialist IIBrea, CA$85,800–$104,800 / yearThis individual is responsible for obtaining global regulatory registrations/approvals based on company objectives, attending product development meetings, regional alignment; as well as collaborating with cross-functional departments to ensure country-specific requirements are met and integrated throughout the design control and post-product launch activities. An Agency must obtain advance written approval from Envista's internal Talent Acquisition or Human Resources team to submit resumes, and then only in conjunction with a valid fully-executed contract approved by the Global Talent Acquisition leader and in response to a specific job opening.
Associate Labeling Specialist – Regulatory Affairs Applied MedicalAssociate Labeling Specialist – Regulatory AffairsRancho Santa Margarita, California$71,000–$80,000 / yearThe Associate Labeling Specialist works cross-functionally to support labeling projects from design input through final approval, making this an ideal opportunity for professionals with a background in regulatory affairs, quality assurance, or technical writing in the medical device industry. Our unique business model, combined with our dedication to delivering the highest quality products, enables team members to contribute in a larger capacity than is possible in typical positions.
Manager II, Regulatory Affairs the Tarsanet Internal Career CenterManager II, Regulatory AffairsIrvine, CaliforniaAssist in performing and managing the initial part of the workflow (Initial QC, routing, scheduling meetings, etc.) in the Veeva system for material review and approval of the materials submitted from the assigned business units. Serve as the Regulatory point of contact for the regulatory promotional perspective and rationale at regulatory project team meetings, labeling meetings, brand team meetings, as needed.
Regulatory Affairs Manager I Alcon ResearchRegulatory Affairs Manager ILake Forest, CaliforniaThe Manager I, Regulatory Affairs Strategy (Professional Path) ), reporting to the Senior Manager of Regulatory Affairs (LLSI), is primarily responsible for coordinating regulatory affairs activities, including product submissions, renewals, and updates, while ensuring compliance and competitive advantage. Collect and analyze regulatory intelligence for China to ensure product compliance and engage in industry associations like Advanced Medical Technology Association (AdvaMed) and Asia Pacific Medical Technology Association (APACMed).
Senior Manager, Regulatory Affairs Strategy Alcon ResearchSenior Manager, Regulatory Affairs StrategyLake Forest, CaliforniaManager, Regulatory Affairs Strategy (Professional Path), 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. A self-starter, assertive leader who will be accountable for the End-to-End regulatory support for the anterior/posterior ophthalmologic products including, but not limited to, new products, sustaining legacy products, and improvements to the product lines.
Principle Regulatory Affairs Strategy Associate Aequor Technologies LLCPrinciple Regulatory Affairs Strategy AssociateLake Forest, CAThe 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. Expectations / Responsibilities: A self-starter, assertive leader who will be accountable for the End-to-End regulatory support for the anterior/posterior ophthalmologic products including, but not limited to, new products, sustaining legacy products, and improvements to the product lines.
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?
NewRegulatory Affairs Associate (Principal) - Medical Devices Apple IncRegulatory Affairs Associate (Principal) - Medical DevicesCupertino, CAThis role will involve assessment of regulatory impact for new and modified Class I, II and III products, including identification of assumptions/risks/mitigations to develop and execute clear regulatory plans in the US and globally. You will represent the RA/QA team on a diverse array of regulatory initiative teams and new product development, with the goal of obtaining approvals for new technologies.
Regulatory Affairs Sr Manager, Regulatory Promotion & Material Compliance AmgenRegulatory Affairs Sr Manager, Regulatory Promotion & Material ComplianceThousand Oaks, CaliforniaIn 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.
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.
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.
Utility Regulatory Affairs Senior Advisor Edison InternationalUtility Regulatory Affairs Senior AdvisorRosemead, CAIn this job, you'll be developing and advocating the Company's positions associated with wholesale generation and energy storage interconnections to SCE's distribution system, including managing the development of revisions to SCE's wholesale distribution access tariff. Become a Utility Regulatory Affairs Senior Advisor at Southern California Edison (SCE) and help meet our goals of interconnecting clean energy resources to SCE's grid.
Manager II, Regulatory Affairs Tarsus Pharmaceuticals IncManager II, Regulatory AffairsIrvine, CARemote$120,000–$168,000 / yearLet's talk about some of the key responsibilities of the role: Assist in performing and managing the initial part of the workflow (Initial QC, routing, scheduling meetings, etc.) in the Veeva system for material review and approval of the materials submitted from the assigned business units. A Few Other Details Worth Mentioning: The position can be either Remote or based in our beautiful Irvine office, complete with onsite gym, pool, snacks, drinks, and occasional catered meals.
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.
Director, Regulatory Affairs Strategy Alcon ResearchDirector, Regulatory Affairs StrategyLake Forest, CaliforniaAs a Director, Regulatory Affairs Strategy (Management Path) supporting Alcon’s Quality & Regulatory Affairs organization, this onsite role based at our Lake Forest, California main campus is responsible for developing and executing regulatory strategies to obtain and maintain product approvals across Alcon’s franchise portfolios. Primary responsibilities include providing strategic regulatory leadership across the product lifecycle, preparing and overseeing high‑quality regulatory submissions, and serving as the primary liaison with global health authorities to support timely product approvals.
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, 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 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.
Manager, Regulatory Affairs iRhythm Holdings IncManager, Regulatory AffairsSan Francisco, CARemote$127,000–$165,000 / yearLead FDA submissions (510(k) or pre-submissions) with the team, including wearable devices, as well as artificial intelligence (AI) Software as a Medical Device (SaMD) products. There have been instances where individuals not associated with iRhythm have impersonated iRhythm employees pretending to be involved in the iRhythm recruiting process, or created postings for positions that do not exist.
Executive Director, Regulatory Affairs Arrowhead Pharmaceuticals IncExecutive Director, Regulatory AffairsSan Diego, CA$280,000–$320,000 / yearArrowhead 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. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes.
Manager, Regulatory Affairs iRhythmManager, Regulatory AffairsSan Francisco, CaliforniaRemoteLead FDA submissions (510(k) or pre-submissions) with the team, including wearable devices, as well as artificial intelligence (AI) Software as a Medical Device (SaMD) products. There have been instances where individuals not associated with iRhythm have impersonated iRhythm employees pretending to be involved in the iRhythm recruiting process, or created postings for positions that do not exist.
Regulatory Affairs Specialist II Envista DentistryRegulatory Affairs Specialist IIBrea, CaliforniaThis individual is responsible for obtaining global regulatory registrations/approvals based on company objectives, attending product development meetings, regional alignment; as well as collaborating with cross-functional departments to ensure country-specific requirements are met and integrated throughout the design control and post-product launch activities. An Agency must obtain advance written approval from Envista's internal Talent Acquisition or Human Resources team to submit resumes, and then only in conjunction with a valid fully-executed contract approved by the Global Talent Acquisition leader and in response to a specific job opening.
Regulatory Affairs Coordinator University of California, IrvineRegulatory Affairs CoordinatorOrange, CaliforniaFull timeProven organizational skills and attention to detail; ability to multi-task, prioritize a complex and dynamic workload, meet rigid deadlines despite interruptions, frequent workload changes and competing demands, and achieve high productivity/quality within short time frames; skill in working independently, taking initiative and following through on assignments and ability to work as part of a team. *Misconduct Disclosure Requirement: As a condition of employment, the final candidate who accepts a conditional offer of employment will be required to disclose if they have been subject to any final administrative or judicial decisions within the last seven years determining that they committed any misconduct; received notice of any allegations or are currently the subject of any administrative or disciplinary proceedings involving misconduct; have left a position after receiving notice of allegations or while under investigation in an administrative or disciplinary proceeding involving misconduct; or have filed an appeal of a finding of misconduct with a previous employer.
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.
Executive Director, Regulatory Affairs Arrowhead PharmaceuticalsExecutive Director, Regulatory AffairsLos Angeles, CA$280,000–$320,000 / yearArrowhead 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. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes.
Sr. Specialist, Regulatory Affairs Metagenics LLCSr. Specialist, Regulatory AffairsAliso Viejo, CAIndustry Surveillance: Monitors competitive claims, FDA's and FTC''s actions, litigation, news releases and other sources, as they relate to the current science of Metagenics-related products and challenges to relevant product claims, to ensure that Metagenics limits its exposure for product claims both domestically and internationally. The wage range for this role takes into account the wide range of factors that are considered in making compensation decisions including but not limited to skill sets; experience and training; licensure and certifications; and other business and organizational needs.
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.