Regulatory Affairs Manager Huisong PharmaceuticalsRegulatory Affairs ManagerSanta Ana, California$38–$48Position Overview Huisong Inc. is seeking an experienced Regulatory Affairs Manager to support regulatory strategy and compliance for dietary supplements, botanical ingredients, herbal extracts, and Traditional Chinese Medicine products. Founded in 1998, Huisong Pharmaceuticals specializes in the research, development, and manufacturing of premium-quality natural ingredients for leading companies in the pharmaceutical, nutraceutical, food and beverage, and personal care industries.
NewBilingual Korean/English Senior Regulatory Affairs Manager - Cosmetics, OTC & Supplements (FDA Compliance Macpower Digital Assets Edge Private LimitedBilingual Korean/English Senior Regulatory Affairs Manager - Cosmetics, OTC & Supplements (FDA ComplianceLos Angeles, CA$90,000–$140,000 / yearGuided by the core values of Beautiful, Healthy, and Refreshing , they innovate beyond traditional cosmetics and household products, delivering creative solutions tailored to evolving consumer needs. As the Senior Regulatory Affairs Manager , you will ensure regulatory compliance for cosmetic, OTC, dietary supplement, and medical device products in North America—from concept to market launch.
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).
Regulatory Affairs Manager Gateway RecruitingRegulatory Affairs ManagerSan Jose, CAThe candidate will combine knowledge of scientific, regulatory, and business issues to enable products, including combination products, that are developed, manufactured or distributed to meet required legislation. 2-5 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related areas.
Regulatory Affairs Manager - APAC - Diabetes Care (on-site) Abbott LaboratoriesRegulatory Affairs Manager - APAC - Diabetes Care (on-site)Alameda, CA$114,000–$228,000 / yearYou will be responsible for managing a small team overseeing the Diabetes Care product portfolio in the APAC region, creating robust global regulatory strategies, working with cross-functional teams as the regulatory SME, provide support for compiling regulatory submissions, and ensuring data is effectively presented for the registration of products in the APAC region. This Regulatory Affairs Manager - APAC position will work closely with in-country regulatory representatives in the Asia Pacific (APAC) region to ensure efficient and compliant business processes and environment.
Regulatory Affairs Manager – APAC - Diabetes Care (on-site) AbbottRegulatory Affairs Manager – APAC - Diabetes Care (on-site)Alameda, CaliforniaYou will be responsible for managing a small team overseeing the Diabetes Care product portfolio in the APAC region, creating robust global regulatory strategies, working with cross-functional teams as the regulatory SME, provide support for compiling regulatory submissions, and ensuring data is effectively presented for the registration of products in the APAC region. This Regulatory Affairs Manager – APAC position will work closely with in-country regulatory representatives in the Asia Pacific (APAC) region to ensure efficient and compliant business processes and environment.
NewRegulatory 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).
Policy & Regulatory Affairs Manager Zoox IncPolicy & Regulatory Affairs ManagerFoster City, CA$137,000–$187,000 / yearThe Policy and Regulatory Affairs at Zoox is a cross-functional organization responsible for advancing Zoox's public policy, regulatory, and political goals, including working with state regulatory agencies, legislators, executive branch, and policymakers. Exceptional project management and organizational skills, with experience successfully supporting the execution of multiple complex, cross-functional projects simultaneously.
Regulatory Affairs Manager - Vascular (on-site) Abbott LaboratoriesRegulatory Affairs Manager - Vascular (on-site)Santa Clara, CA$114,000–$228,000 / yearThe candidate will combine knowledge of scientific, regulatory, and business issues to enable products, including combination products, that are developed, manufactured or distributed to meet required legislation. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents.
Policy & Regulatory Affairs Manager ZooxPolicy & Regulatory Affairs ManagerFoster City, CAThe Policy and Regulatory Affairs at Zoox is a cross-functional organization responsible for advancing Zoox's public policy, regulatory, and political goals, including working with state regulatory agencies, legislators, executive branch, and policymakers. The Policy and Regulatory Affairs Manager will support Zoox’s state policy portfolio, providing important project management, public policy analysis, and help to implement Zoox’s state policy strategy.
Regulatory Affairs Manager Karwell TechnologiesRegulatory Affairs ManagerIrvine, CAResponsibilities: In this critical role, you will lead regulatory strategies, product submissions, and a team of talented regulatory affairs professionals to drive timely product approvals and ensure ongoing regulatory compliance in key markets such as USA (FDA), EU (MDR), China (NMPA), and more. You will work cross-functionally with Clinical, Global Regulatory Affairs counterparts, and others to support innovation and expand market access for our advanced ultrasound technologies and solutions.
Regulatory Affairs Manager Katalyst Healthcares & Life SciencesRegulatory Affairs ManagerIrvine, CAResponsibilities: In this critical role, you will lead regulatory strategies, product submissions, and a team of talented regulatory affairs professionals to drive timely product approvals and ensure ongoing regulatory compliance in key markets such as USA (FDA), EU (MDR), China (NMPA), and more. You will work cross-functionally with Clinical, Global Regulatory Affairs counterparts, and others to support innovation and expand market access for our advanced ultrasound technologies and solutions.
Senior Manager, Regulatory Affairs - Lingo (on-site) Abbott LaboratoriesSenior Manager, Regulatory Affairs - Lingo (on-site)Alameda, CA$130,700–$261,300 / yearOur portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Working on Lingo, you will help build a next-generation technology that enables individuals to make decisions about how to improve energy, lose weight or enhance athletic performance.
Manager, Regulatory Affairs Jade BiosciencesManager, Regulatory AffairsSan Francisco, CaliforniaRemote$135,000–$150,000 / yearJade’s pipeline also includes JADE201, an afucosylated anti-BAFF-R monoclonal antibody, as well as JADE301, an undisclosed antibody candidate, both currently in preclinical development. Participate in the review of key clinical and nonclinical documents (protocols, IBs, CSRs, DSURs, etc.) to ensure alignment with regulatory obligations and relevant guidelines (ICH, FDA, EMA, ROW).
Regulatory Affairs Manager – Diabetes Care (on-site) AbbottRegulatory Affairs Manager – Diabetes Care (on-site)Alameda, CaliforniaAs 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.
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 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.
Manager II, Regulatory Affairs Tarsus PharmaceuticalsManager II, Regulatory AffairsIrvine, CaliforniaRemoteAssist 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.
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.
NewSenior 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.
Regulatory Affairs Quality/Standards/Training Manager - Remote Roth Staffing CompaniesRegulatory Affairs Quality/Standards/Training Manager - RemoteAlameda, CaliforniaRemote$85–$93.68 / hourCollaborate with Quality Assurance and cross‑functional stakeholders to support health authority inspections across GPS and Regulatory Affairs, ensuring the RA function remains in a continuous state of inspection readiness. · Work with Regulatory Affairs Strategist, CRO and Clinical Operations to ensure the Trial Master File (TMF) and Veeva RIM is kept current and complete for Regulatory Affairs-related documents.
Manager, Product Integrity, Regulatory & Scientific Affairs Noodle & Boo, Inc.Manager, Product Integrity, Regulatory & Scientific AffairsCerritos, CANoodle & Boo is seeking a highly organized, scientifically rigorous, and detail-oriented Manager, Product Integrity, Regulatory & Scientific Affairs to support the day-to-day execution of formula governance, regulatory documentation, product compliance, technical recordkeeping, claims substantiation, COA review, and manufacturing quality consistency across our premium baby, maternity, and family care portfolio. Reporting to the Founder and ultimately the VP Product / Chief Product Officer, this role is cross-functional and operationally important, but remains a manager-level, hands-on role focused on execution, documentation control, quality follow-up, and compliance support.
Senior Regulatory Affairs Specialist - Manager Synaptic Medical LLCSenior Regulatory Affairs Specialist - ManagerCarlsbad, CAKey responsibilities: Lead the regulatory strategy for new product development and market entry, including 510(k), PMA, and CE Mark submissions. What we are looking for: Bachelor's degree in a scientific, engineering, or related field (RAC certification or advanced degree a plus).
Senior Manager, Regulatory Affairs TMTT Edwards LifesciencesSenior Manager, Regulatory Affairs TMTTIrvine, CA$145,000–$205,000 / yearWorking in partnership with external government and regulatory authorities, and alongside diverse internal stakeholders, your close attention to detail and technical mastery will help ensure our products reach clinicians and improve patients’ lives. Includes representing the regulatory function on manufacturing and product development teams to provide input on regulatory requirements, including providing alternatives for meeting regulatory requirements and resolving complex conflicts between those requirements and development issues.
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.
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.
Senior Manager, Regulatory Affairs - Lingo (on-site) AbbottSenior Manager, Regulatory Affairs - Lingo (on-site)Alameda, CaliforniaOur portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Working on Lingo, you will help build a next-generation technology that enables individuals to make decisions about how to improve energy, lose weight or enhance athletic performance.
Senior Manager, Commercial Regulatory Affairs Revolution MedicinesSenior Manager, Commercial 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. As part of the Regulatory Affairs function, the Senior Manager will work under supervision to provide strategic regulatory advice on advertising/promotion and medical materials to the US organization for assigned products in accordance with business goals and objectives, FDA regulations/guidances, pharma guidelines, and company policy.
Senior Manager, Commercial Regulatory Affairs Revolution Medicines IncSenior Manager, Commercial Regulatory AffairsRedwood City, CA$164,000–$205,000 / 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. As part of the Regulatory Affairs function, the Senior Manager will work under supervision to provide strategic regulatory advice on advertising/promotion and medical materials to the US organization for assigned products in accordance with business goals and objectives, FDA regulations/guidances, pharma guidelines, and company policy.
Senior Manager, Regulatory Affairs RitualSenior Manager, Regulatory AffairsLos Angeles, CaliforniaRemoteProactively manage team capacity, anticipating bandwidth constraints, redistributing workload, and communicating trade-offs before they become obstacles for cross-functional partners. You'll report directly to the Director of Legal & Strategy, lead the regulatory team, and serve as a critical cross-functional partner to Legal, R&D, Innovation, Marketing, Quality, and Operations.
(Senior) Manager, Regulatory Affairs Braveheart Bio(Senior) Manager, Regulatory AffairsSan Francisco, CaliforniaOur lead product candidate, BHB-1893, is a next-generation oral small-molecule cardiac myosin inhibitor (CMI) being developed for the treatment of obstructive HCM (oHCM) and non-obstructive HCM (nHCM). Reporting into the Vice President of Regulatory Affairs, this individual will manage the CRO(s) responsible for preparing CTAs, as well as coordinate preparation of cross‑functional deliverables and manage health authority queries and responses.
Regulatory Affairs Manager ORIC Pharmaceuticals IncRegulatory Affairs ManagerSan Diego, CA$145,000–$165,000 / yearORIC's clinical stage product candidates include (1) ORIC-944, an allosteric inhibitor of the polycomb repressive complex 2 (PRC2) via the EED subunit, being developed for prostate cancer, and (2) ORIC-114, a brain penetrant inhibitor that selectively targets EGFR exon 20, HER2 exon 20 and EGFR atypical mutations, being developed across multiple genetically defined cancers. Excellent writing and editorial skills, with the ability to develop high-quality clinical-regulatory documents (eg, investigator brochures, briefing documents, IND amendments, Fast Track/ODD designation requests).
Regulatory Affairs, Sr Manager – Obesity and Related Conditions AmgenRegulatory Affairs, Sr Manager – Obesity and Related ConditionsThousand 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.
Project 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.
SENIOR MANAGER, REGULATORY AFFAIRS Sutro Biopharma IncSENIOR MANAGER, REGULATORY AFFAIRSSouth San Francisco, CA$153,000–$175,000 / yearPosition Overview: Sutro has a unique capability that enables new molecular entities to be designed using a hybrid of synthetic and recombinant technologies to create best in class therapeutics in the oncology and auto-immune disease space. Sutro is advancing a robust early-stage pipeline of novel exatecan and dual-payload antibody drug conjugates (ADCs), coupled with high-value collaborations and industry partnerships, which validate its continuous product innovation.
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.
Senior Manager, Government & Regulatory Affairs GEICO GENERAL INSURANCE COMPANYSenior Manager, Government & Regulatory AffairsSacramento, CA$158,875–$248,050 / yearWhat You'll Do: Policymaker Engagement: Build and maintain a strong network of key policymakers, including state legislators, heads of relevant executive agencies and their staff, industry members, policymakers (NAIC and NCOIL), and trade associations to efficiently and effectively advocate GEICO's positions in assigned states. Strategic Monitoring & Reporting: Proactively identify evolving regulatory and legislative trends and effectively communicate relevant insights and potential risks to the Government & Regulatory Affairs team, business units, and senior management to support informed, enterprise-wide strategic decision-making.
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 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.
Manager, Global Regulatory Affairs Project Management Revolution Medicines IncManager, Global Regulatory Affairs Project ManagementRedwood City, CA$143,000–$178,000 / yearThe Opportunity: The Manager, Global Regulatory Affairs Project Management is an integral part of the global Regulatory Affairs organization and is responsible for translating complex global regulatory strategies into actionable execution plans, in partnership with and reporting to a Director, Global Regulatory Affairs Project Management. 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.
Manager, Global Regulatory Affairs Project Management Revolution MedicinesManager, Global Regulatory Affairs Project ManagementRedwood City, CaliforniaThe Manager, Global Regulatory Affairs Project Management is an integral part of the global Regulatory Affairs organization and is responsible for translating complex global regulatory strategies into actionable execution plans, in partnership with and reporting to a Director, Global Regulatory Affairs Project Management. 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.
Manager, Regulatory Affairs & Market Development Bidgely Inc.Manager, Regulatory Affairs & Market DevelopmentLos Altos, CARemote$140,000You will operate as a core member of Bidgely’s Regulatory Affairs function, working closely with internal partners across Sales, Go-to-Market, Product, and Engineering to ensure regulatory strategy actively supports customer adoption and market expansion. You will: Monitor and analyze state-level regulatory proceedings, legislation, and utility plans related to grid modernization, data analytics, demand-side management, energy efficiency, and customer experience.
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.
Senior Manager Regulatory Affairs contract Alumis IncSenior Manager Regulatory Affairs contractSouth San Francisco, CA$165,000–$195,000 / yearEDUCATION/EXPERIENCE/SKILLS: Bachelor's or advanced degree in scientific discipline, with a minimum of 5 years of experience working in drug development in the biopharmaceutical industry and at least 3 years of experience in Regulatory Affairs; immunology or rare disease/ orphan drug development experience desirable. We are seeking an exceptionally motivated individual to provide leadership and support to global regulatory activities to achieve Alumis' strategic vision in obtaining worldwide approvals to market our products.
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.
Regulatory Affairs Program Manager- Pleasanton, CA CalyxoRegulatory Affairs Program Manager- Pleasanton, CAPleasanton, CA$160,000–$175,000 / yearAs a senior member of the Calyxo Regulatory Team, you will work closely with Research & Development, Operations, Quality, Clinical and Medical Affairs, Marketing, and Legal to ensure regulatory alignment from concept through commercialization—balancing speed with compliance as we bring category-defining medical devices to market. Lead the strategy, preparation, submission, and negotiation of complex U.S. and international regulatory filings (including 510(k)s, Q-Subs/Pre-Submissions, Special 510(k)s, and Letters to File), ensuring timely approvals and serving as the technical lead on the most challenging submissions.
Sr Manager/Assoc Director, CMC Regulatory Affairs Erasca IncSr Manager/Assoc Director, CMC Regulatory AffairsSan Diego, CA$175,000–$205,000 / yearAssess proposed CMC changes (e.g., manufacturing processes, analytical methods, specifications, manufacturing sites, container closure systems, stability programs, and suppliers) and support development of appropriate global regulatory filing strategies. Position Responsibilities: Deliver CMC regulatory support through QC review of submission components, including CMC documents, labeling, application forms, supporting GMP documentation, cover letters and verification of submission links, ensuring completeness, consistency, and compliance with regulatory requirements.
Sr. Manager, Regulatory Affairs VaxcyteSr. Manager, Regulatory AffairsSan Carlos, California$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.