Project Manager, Regulatory Affairs Enigma SearchProject Manager, Regulatory AffairsCaliforniaWorking closely with Regulatory Affairs, Medical Writing, and Regulatory Operations teams, you will help implement practical project management processes that drive the timely execution of key regulatory milestones and support ongoing clinical development efforts. Proven experience developing and managing project plans, timelines, trackers, dashboards, meeting materials, and status communications across cross-functional teams; proficiency with project management tools is preferred.
Senior Manager, Regulatory Affairs Labeling Mirum Pharmaceuticals IncSenior Manager, Regulatory Affairs LabelingFoster City, CA$175,000–$195,000 / yearThe Senior Manager (SM), Regulatory Affairs Labeling will play a key role in providing regulatory expertise and guidance to internal stakeholders for successful development and implementation of global regulatory labeling strategy and documentation for marketed products. Create and update labeling content for assigned programs of marketed product(s) and development products in US and international regions including: CCDS, prescribing information, medication guides, patient information/leaflet/IFU, package label artwork.
Senior Manager, CMC Regulatory Affairs (Biologics) Travere Therapeutics IncSenior Manager, CMC Regulatory Affairs (Biologics)San Diego, CARemote$132,000–$172,000 / yearThe Senior Manager serves as the primary CMC Regulatory Affairs representative on cross-functional teams and partners closely with Technical Operations, Process Development, Pharmaceutical Development, Manufacturing, Quality, Analytical Development, Supply Chain, Regulatory Operations, and Project Management to ensure alignment of CMC development plans with global regulatory requirements and business objectives. This role leads the development and execution of global CMC regulatory strategies to support clinical development, marketing applications, and lifecycle management activities for biologic products, with a strong focus on late-stage development, Phase 3 programs, and rare disease therapeutics.
Manager, Regulatory Affairs Iovance Biotherapeutics IncManager, Regulatory AffairsSan Carlos, CARemote$140,000–$160,000 / yearMental: Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines. Organizational and planning skills; ability to influence and negotiate professionally at various levels within the project team and with external partners while maintaining positive working relationships.
Manager Regulatory Affairs Device-Combination Products AbbVie IncManager Regulatory Affairs Device-Combination ProductsIrvine, CARepresents Device Regulatory Affairs on teams such as the product development, Global Regulatory Product Teams and Operations brand teams, for assigned projects; negotiates with and influences team members with support of management to maximize chances for first pass approval of regulatory submissions. The amount and availability of any bonus, commission,incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless anduntil paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.
Manager, Regulatory and Market Affairs Pattern Energy Group LPManager, Regulatory and Market AffairsSan Francisco, California$103,000–$138,000 / yearA key function of this role will be to identify, research, analyze, and synthesize the cross section of regulatory and wholesale market rules impacting Pattern’s existing and planned assets in WECC, MISO, ERCOT, SPP, PJM and other priority markets as needed. Importantly, the role will support the coordination with expert consultants and internal SMEs to clearly and regularly identify and lead Pattern’s engagement in regulatory and market design changes, develop Pattern’s positions and execute on strategies to achieve desired objectives.
Manager, Regulatory Affairs Strategy Travere Therapeutics IncManager, Regulatory Affairs StrategySan Diego, CARemote$116,000–$151,000 / yearPosition Summary: The Manager, Regulatory Affairs provides regulatory leadership and execution support for late-stage development programs and contributes to the implementation of global regulatory strategies from development through registration and lifecycle management activities. We stick by our values centered on patients, courage, community, and collaboration to pursue our vision of becoming a leading biopharmaceutical company dedicated to the delivery of innovation and hope to patients in the global rare disease community.
Manager, Regulatory and Market Affairs Pattern Energy Group IncManager, Regulatory and Market AffairsSan Francisco, CA$103,000–$138,000 / yearA key function of this role will be to identify, research, analyze, and synthesize the cross section of regulatory and wholesale market rules impacting Pattern's existing and planned assets in WECC, MISO, ERCOT, SPP, PJM and other priority markets as needed. Importantly, the role will support the coordination with expert consultants and internal SMEs to clearly and regularly identify and lead Pattern's engagement in regulatory and market design changes, develop Pattern's positions and execute on strategies to achieve desired objectives.
Supervisor, Regulatory Affairs Inland Empire Health PlanSupervisor, Regulatory AffairsRancho Cucamonga, California$104,041.60–$137,841.60 / yearFull timeIn partnership with the Regulatory Affairs Manager, the Supervisor plays a critical role in maintaining organizational compliance with complex requirements issued by the Centers for Medicare and Medicaid Services (CMS), Department Health Care Services (DHCS), Department of Managed Health Care (DMHC), and Covered California, as these apply to the team’s assigned line of business. Deep understanding of Federal and State regulatory frameworks governing Medi-Cal (Medicaid), Medicare, and related statutory and regulatory authorities, including Title 19 (USC) / Title 29 (USC and CFR), Title 22 (CCR), Title 28 (CCR), Title 42 (USC and CFR), California Welfare and Institutions Code (WIC), and the California Health and Safety Code.
Sr. Manager, Regulatory Affairs Vaxcyte IncSr. Manager, Regulatory AffairsSan Carlos, CA$183,000–$194,000 / yearEssential Functions: Represent Regulatory Affairs in various internal cross-functional project teams, improvement initiatives and providing regulatory positions on various CMC related topics. Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked.
Manager, Regulatory Affairs Arrowhead Pharmaceuticals IncManager, Regulatory AffairsPasadena, CA$145,000–$160,000 / 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.
Senior Manager/Associate Director, Regulatory Affairs (Strategy, Hematology Oncology) Nurix Therapeutics, Inc.Senior Manager/Associate Director, Regulatory Affairs (Strategy, Hematology Oncology)Brisbane, CA$187,800–$208,638 / yearWorks 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. Job Summary: In this role, you 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.
Regulatory Affairs Manager - Diabetes Care (on-site) Abbott LaboratoriesRegulatory Affairs Manager - Diabetes Care (on-site)Milpitas, CA$114,000–$228,000 / yearAs a member of the U.S. Regulatory Affairs management team, the successful candidate will lead and develop talent, shape regulatory strategy, and partner across functions to bring innovative products to market, whilst driving regulatory excellence for the manufacture, change management, and ongoing supply of the Libre portfolio. Drive and provide strategic guidance on FDA pathways, submissions, and interactions, including pre-submissions, 510(k), PMA, and post-market activities.
Sr. Manager, Regulatory Affairs VaxcyteSr. Manager, Regulatory AffairsSan Carlos, California$183,000–$194,000 / yearReports to: Executive Director, Regulatory CMC Location: US - Remote Work Arrangement (may be adjusted based on business needs, job responsibilities, or changes to company policy): Remote Compensation: The compensation package will be competitive and includes comprehensive benefits and an equity component. Essential Functions: Represent Regulatory Affairs in various internal cross-functional project teams, improvement initiatives and providing regulatory positions on various CMC related topics.
Senior Manager, Regulatory Intelligence & Corporate Regulatory Affairs Edwards Lifesciences CorpSenior Manager, Regulatory Intelligence & Corporate Regulatory AffairsIrvine, CA$145,000–$205,000 / yearIdentify systemic risks, process gaps, and opportunities for improvement; develop innovative solutions; and independently lead multiple complex, enterprise-level regulatory initiatives and process-improvement programs across business units, regions, and functional areas, with accountability for scope, strategy, risk, timelines, deliverables, and sustainable outcomes. This role provides strategic regulatory leadership on worldwide regulatory changes, translates complex requirements into actionable business strategies, and independently leads high-impact, cross-functional initiatives that support global compliance and timely patient access to life-saving products and therapies.
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 Manager/Associate Director, Regulatory Affairs Strategy, Hematology Oncology Nurix Therapeutics IncSenior Manager/Associate Director, Regulatory Affairs Strategy, Hematology OncologyBrisbane, CA$187,800–$208,638 / yearWorks 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. Job Summary: In this role, you 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.
Senior Manager, Regulatory Affairs and Compliance Traditional MedicinalsSenior Manager, Regulatory Affairs and ComplianceRohnert Park, CA$155,900–$204,645 / yearThe role serves as the functional leader for Regulatory Affairs and Compliance at the Company, with responsibility for establishing regulatory strategy, providing authoritative regulatory guidance, and building and operating the systems, governance, and capabilities necessary to support the Company’s growth. The ideal candidate is equally comfortable interpreting regulatory requirements, coordinating cross-functional compliance activities, supporting audit/inspection readiness, and building scalable processes that reduce reliance on fragmented/manual coordination.
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. 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.