Aviation Regulatory Affairs Manager Rainmaker Technology CorporationAviation Regulatory Affairs ManagerEl Segundo, CaliforniaTrack and analyze FAA rulemaking with material impact on Rainmaker, including Part 108 BVLOS, evolving airworthiness frameworks, and federal contracting prerequisites (American Security Drone Act, FAR 52.240-1, DoD Blue UAS Cleared List). In doing so, they are expected to continuously challenge and improve how Rainmaker designs operating concepts, builds safety cases, and positions itself with the FAA — building durable institutional credibility that compounds across waivers, certifications, and rulemaking cycles.
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 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 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 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, 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.
Senior Manager Regulatory Affairs (Contract) Alumis Inc.Senior Manager Regulatory Affairs (Contract)South San Francisco, CA$165,000–$195,000 / yearBachelor'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.
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 / 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.
Regulatory Affairs Manager - Heart Failure (on-site) Abbott LaboratoriesRegulatory Affairs Manager - Heart Failure (on-site)Pleasanton, CA$114,000–$228,000 / yearAs an individual contributor, the function of a Regulatory Affairs Manager is to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines.
Sr Manager/Assoc Director, CMC Regulatory Affairs ErascaSr Manager/Assoc Director, CMC Regulatory AffairsSouth San Francisco, CAAssess 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. 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/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.
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.
NewManager, Regulatory Affairs Noctrix HealthManager, Regulatory AffairsPleasanton, CA$150,000–$180,000 / yearThe Manager, Regulatory Affairs will work closely with Clinical Affairs, Quality, Engineering, Operations, Marketing, and external regulatory partners to provide regulatory guidance, manage submissions, assess product changes, maintain global registrations, and support post-market regulatory activities. We are seeking an experienced and highly organized Manager, Regulatory Affairs to lead and execute regulatory activities supporting the development, registration, commercialization, and post-market compliance of Noctrix Health's medical devices.
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.
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.
Regulatory Affairs and Compliance Senior Advisor Edison InternationalRegulatory Affairs and Compliance Senior AdvisorRosemead, CA$161,700–$242,600 / yearIn this job, you'll act as the External Regulatory Audit Manager, responsible for managing the Company's response to multiple external regulatory audits simultaneously conducted by the CPUC, Office of Electric Infrastructure Safety (OEIS), FERC, 3rd Party Auditors, NERC and WECC that have financial, operational, and/or regulatory impact on the Company. Experience working in any of the following organizational units: Energy Procurement, Transmission and Distribution, Customer Service Programs, Regulatory Affairs, or Finance.
NewRegulatory Affairs Specialist Scale MediaRegulatory Affairs SpecialistBurbank, CARemoteFull timePrepare and present industry updates at recurring team meetings (e.g., a monthly regulatory round-up), keeping cross-functional partners aware of what's happening and why it matters. Comfort with quality or product documentation basics — reviewing specifications or Certificates of Analysis (COAs) and meeting the documentation timelines that gate product release.
Senior Manager, Regulatory Affairs Natals IncSenior Manager, Regulatory AffairsLos Angeles, CARemote$144,500–$185,000 / yearProactively 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 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.
Sr. Regulatory Affairs Specialist, Medical Devices (Long Beach, CA) Beauty Health Group LimitedSr. Regulatory Affairs Specialist, Medical Devices (Long Beach, CA)Long Beach, CA$107,500–$125,000 / yearAn employee's pay position within the salary range will be based on several factors including, but not limited to, relevant education, qualifications, certifications, experience, skills, seniority, geographic location, performance, travel requirements, revenue-based metrics, any contractual agreements, and business or organizational needs. This includes developing regulatory planning, preparing submissions, ensuring ongoing compliance with applicable regulations such as U.S. FDA and international market regulations, and supporting cross-functional teams to bring innovative solutions to market safely and efficiently.
Strategy and Operations Lead, Regulatory Affairs Google LLCStrategy and Operations Lead, Regulatory AffairsMountain View, CA10 years of experience in management consulting, operations, business strategy, regulatory, legal or corporate advisory, or 8 years of experience with an advanced degree. Advise Regulatory Affairs leadership on critical OKRs, business plans, and operating plans while defining change management strategies to implement new initiatives.
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.
Principal Regulatory Affairs Specialist Procept BioroboticsPrincipal Regulatory Affairs SpecialistSan Jose, CAIt continues with our one-of-a-kind management program designed to build the best managers in the industry, where our people managers across functions come together to exchange ideas and grow, as both managers and learners, in an environment that challenges, supports and broadens. What Your Day-To-Day Will Involve: Regulatory representation and leadership to cross-functional products teams, development of regulatory strategies and support PROCEPT's products, marketing applications and post-market activities.
Regulatory Affairs Specialist EnvistaRegulatory Affairs SpecialistBrea, 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.
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.
Senior Regulatory Affairs Specialist Procept BioroboticsSenior Regulatory Affairs SpecialistSan Jose, CAIt continues with our one-of-a-kind management program designed to build the best managers in the industry, where our people managers across functions come together to exchange ideas and grow, as both managers and learners, in an environment that challenges, supports and broadens. Act as a lead regulatory representative on product development teams, communicate regulatory requirements and impact of regulations to project teams, and provides input related to FDA and international product registrations and licensing requirements.
Sr. Regulatory Affairs Specialist, Medical Devices (Long Beach, CA) BeautyHealthSr. Regulatory Affairs Specialist, Medical Devices (Long Beach, CA)Long Beach, CaliforniaAn employee’s pay position within the salary range will be based on several factors including, but not limited to, relevant education, qualifications, certifications, experience, skills, seniority, geographic location, performance, travel requirements, revenue-based metrics, any contractual agreements, and business or organizational needs. This includes developing regulatory planning, preparing submissions, ensuring ongoing compliance with applicable regulations such as U.S. FDA and international market regulations, and supporting cross-functional teams to bring innovative solutions to market safely and efficiently.
Director, Regulatory Affairs Advertising & Promotion Acadia Pharmaceuticals IncDirector, Regulatory Affairs Advertising & PromotionSan Diego, CA$193,400–$241,800 / yearThe position partners closely with cross-functional teams to support the timely approval and distribution of promotional and disease state materials, serves as the primary liaison with the FDA''s Office of Prescription Drug Promotion (OPDP) for advertising and promotional submissions, and contributes to labeling strategies for regulatory submissions across Acadia''s product portfolio. We are developing the next wave of therapeutic advancements with a robust and diverse pipeline that includes mid- to late-stage programs in Alzheimer's disease psychosis and Lewy body dementia psychosis, along with earlier-stage programs that address other underserved patient needs.
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.
Implant Direct Regulatory Affairs Specialist (Thousand Oaks, CA) Envista Holdings CorpImplant Direct Regulatory Affairs Specialist (Thousand Oaks, CA)Thousand Oaks, CA$85,800–$104,800 / yearEnvista will consider unsolicited referrals and/or resumes submitted by vendors such as search firms, staffing agencies, professional recruiters, fee-based referral services and recruiting agencies (Agency) to have been referred by the Agency free of charge and Envista will not pay a fee for any placement resulting from the receipt such unsolicited resumes. 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.
Implant Direct Regulatory Affairs Specialist (Thousand Oaks, CA) EnvistaImplant Direct Regulatory Affairs Specialist (Thousand Oaks, CA)Thousand Oaks, CA$85,800–$104,800 / yearEnvista will consider unsolicited referrals and/or resumes submitted by vendors such as search firms, staffing agencies, professional recruiters, fee-based referral services and recruiting agencies (Agency) to have been referred by the Agency free of charge and Envista will not pay a fee for any placement resulting from the receipt such unsolicited resumes. 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.
Principal Regulatory Affairs Specialist Procept Biorobotics CorpPrincipal Regulatory Affairs SpecialistSan Jose, CA$220,670–$259,610 / yearIt continues with our one-of-a-kind management program designed to build the best managers in the industry, where our people managers across functions come together to exchange ideas and grow, as both managers and learners, in an environment that challenges, supports and broadens. What Your Day-To-Day Will Involve: Regulatory representation and leadership to cross-functional products teams, development of regulatory strategies and support PROCEPT's products, marketing applications and post-market activities.
Senior Regulatory Affairs Specialist Procept Biorobotics CorpSenior Regulatory Affairs SpecialistSan Jose, CA$148,550–$174,770 / yearIt continues with our one-of-a-kind management program designed to build the best managers in the industry, where our people managers across functions come together to exchange ideas and grow, as both managers and learners, in an environment that challenges, supports and broadens. Act as a lead regulatory representative on product development teams, communicate regulatory requirements and impact of regulations to project teams, and provides input related to FDA and international product registrations and licensing requirements.
Staff Regulatory Affairs Specialist Procept Biorobotics CorpStaff Regulatory Affairs SpecialistCAWhat Your Day-To-Day Will Involve: Act as a lead regulatory representative on core product development teams, communicates regulatory requirements and impact of regulations to project teams, and provides input related to FDA and international product registrations and licensing requirements. It continues with our one-of-a-kind management program designed to build the best managers in the industry, where our people managers across functions come together to exchange ideas and grow, as both managers and learners, in an environment that challenges, supports and broadens.
Director, CMC Regulatory Affairs Vir Biotechnology, Inc.Director, 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).
Regulatory Affairs and Compliance Senior Advisor Southern California EdisonRegulatory Affairs and Compliance Senior AdvisorRosemead, CA$161,700–$242,600 / yearIn this job, you'll act as the External Regulatory Audit Manager, responsible for managing the Company's response to multiple external regulatory audits simultaneously conducted by the CPUC, Office of Electric Infrastructure Safety (OEIS), FERC, 3 rd Party Auditors, NERC and WECC that have financial, operational, and/or regulatory impact on the Company. + Experience working in any of the following organizational units: Energy Procurement, Transmission and Distribution, Customer Service Programs, Regulatory Affairs, or Finance.
NewPrincipal Regulatory Affairs Specialist PROCEPT BioRobotics CorporationPrincipal Regulatory Affairs SpecialistSan Jose, CaliforniaIt continues with our one-of-a-kind management program designed to build the best managers in the industry, where our people managers across functions come together to exchange ideas and grow, as both managers and learners, in an environment that challenges, supports and broadens. Responsible for project timelines and management of regulatory submissions including preparing IDE, 510K and international submissions for new products, new indications, and significant product changes, to ensure compliance with the FDA and international regulations and guidelines.
NewVice President, Quality & Regulatory Affairs Nihon Kohden America, LLCVice President, Quality & Regulatory AffairsIrvine, CA$215,000–$300,000 / yearThe Vice President serves as the primary liaison with regulatory authorities and certification bodies and partners closely with Nihon Kohden Corporation (NKC) to identify and implement the most efficient, compliant, and customer-focused approaches to regulatory, quality, and post-market activities. Serving as the Company's Management Representative, this position ensures the effectiveness and continuous improvement of the Quality Management System (QMS) while supporting the Company's sales, marketing, service, clinical support, and product lifecycle management activities.
Regulatory Affairs Specialist Quidelortho CorpRegulatory Affairs SpecialistSan Diego, CAQuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. Regulatory Operations provides infrastructure to the broader department through the creation and continuous improvement of regulatory processes, implementation and maintenance of regulatory software systems, and management of centralized regulatory services and support functions.
Staff Regulatory Affairs Specialist PROCEPT BioRobotics CorporationStaff Regulatory Affairs SpecialistCaliforniaIt continues with our one-of-a-kind management program designed to build the best managers in the industry, where our people managers across functions come together to exchange ideas and grow, as both managers and learners, in an environment that challenges, supports and broadens. Act as a lead regulatory representative on core product development teams, communicates regulatory requirements and impact of regulations to project teams, and provides input related to FDA and international product registrations and licensing requirements.
Senior Regulatory Affairs Specialist PROCEPT BioRobotics CorporationSenior Regulatory Affairs SpecialistSan Jose, CaliforniaIt continues with our one-of-a-kind management program designed to build the best managers in the industry, where our people managers across functions come together to exchange ideas and grow, as both managers and learners, in an environment that challenges, supports and broadens. Act as a lead regulatory representative on product development teams, communicate regulatory requirements and impact of regulations to project teams, and provides input related to FDA and international product registrations and licensing requirements.
Senior 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.
Senior 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 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.
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.