Associate Director, State Government Affairs - Remote Agios PharmaceuticalsAssociate Director, State Government Affairs - RemoteSan Francisco, CARemote$153,541–$230,312 / yearThe current base salary range for this position is expected to be between $153,541 and $230,312 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators. Our team’s proven track record of executional excellence, combined with our depth of expertise and dedication, enables us to develop innovative medicines that reflect the priorities of rare disease communities.
Regulatory Affairs Specialist - Vascular (on-site) Abbott LaboratoriesRegulatory Affairs Specialist - Vascular (on-site)Santa Clara, CA$81,500–$141,300 / yearOur extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents. The ideal candidate will possess strong analytical and project management skills, a working knowledge of medical device regulations, and the ability to interpret complex regulatory requirements and apply them to product development and lifecycle management activities.
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 ProSomnus IncSenior Regulatory Affairs SpecialistPleasanton, CADevelop and implement global regulatory strategies for medical device products (Class I-II as applicable) Prepare, compile, and support FDA regulatory submissions, including 510(k)s, De Novo submissions, Technical Documentation (EU MDR), CE Mark submissions, supplements, and amendments, and international registrations. This role is responsible for developing and executing global regulatory strategies, prepares and manages submissions and registrations, conducts regulatory gap assessments, and supports international market expansion efforts.
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.
Regulatory Affairs Specialist 4 ICONMA, LLCRegulatory Affairs Specialist 4Sunnyvale, CA$53.65–$58.65 / hourRequirements: Minimum 8 years of regulatory affairs experience working in a medical device company (can be in combination with a regulatory affairs master degree; e.g., Masters in Regulatory Science). Regulatory working knowledge of product lifecycle management, design controls, risk management, verification and validation, and product labeling requirement.
Principal Regulatory Affairs Specialist - APAC - Diabetes Care (on-site) Abbott LaboratoriesPrincipal Regulatory Affairs Specialist - APAC - Diabetes Care (on-site)Alameda, CA$100,000–$200,000 / yearCoordinate with cross functional teams including but not limited to: global Regulatory Affairs (e.g., APAC, CALA, EMEAP and US), Commercial, Marketing / PLC, Supply Planning, Customer Service, Quality, R&D, Operations, etc. to ensure all internal and external requirements are met prior to product release. This Principal Regulatory Affairs Specialist position is responsible for leading strategic planning as well as developing and deploying innovative solutions to ensure timely regulatory registration and release of products for distribution into specific geographies in the growing Asia Pacific (APAC) market.
Senior Regulatory Affairs Specialist Volt Information Sciences IncSenior Regulatory Affairs SpecialistSanta Clara, CA$55–$59 / hourBuild your future with VoltVolt is immediately hiring for Senior Regulatory Affairs Specialist in Santa Clara CaliforniaAs a Senior Regulatory Affairs Specialistyou will Develops and implements programs and processes to ensure that company products are safe legal and meet or exceed customer expectations for compliance with nationalregionalglobal regulations. PAY RANGE AND BENEFITSPay Range 55 - 59 per hourPay range offered to a successful candidate will be based on several factors including the candidates education work experience work location specific job duties certifications etc.
Regulatory Affairs Specialist 4 eTeam Inc.Regulatory Affairs Specialist 4Sunnyvale, CA$58–$59 / hourStrong verbal and written communication skills, proven ability to translate technical documentation into effective internal documentation, and regulatory submissions. " Provide regulatory guidance to product teams, develop regulatory plans, and review and approve product design control documentation.
Principal Regulatory Affairs Specialist – APAC - Diabetes Care (on-site) AbbottPrincipal Regulatory Affairs Specialist – APAC - Diabetes Care (on-site)Alameda, CaliforniaCoordinate with cross functional teams including but not limited to: global Regulatory Affairs (e.g., APAC, CALA, EMEAP and US), Commercial, Marketing / PLC, Supply Planning, Customer Service, Quality, R&D, Operations, etc. to ensure all internal and external requirements are met prior to product release. This Principal Regulatory Affairs Specialist position is responsible for leading strategic planning as well as developing and deploying innovative solutions to ensure timely regulatory registration and release of products for distribution into specific geographies in the growing Asia Pacific (APAC) market.
Regulatory Affairs Specialist 3 - Multiport da Vinci Intuitive Surgical IncRegulatory Affairs Specialist 3 - Multiport da VinciSunnyvale, CACertain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government's licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan ("TCP") (note: typically adds 2 weeks to the hiring process). U.S. Export Controls Disclaimer: In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employees who are nationals from countries currently on embargo or sanctions status.
Regulatory Affairs Specialist III Thermo Fisher Scientific IncRegulatory Affairs Specialist IIIFremont, CA$90,900–$121,200 / yearWe provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy.
Senior Regulatory Affairs Specialist - Lingo (on-site) Abbott LaboratoriesSenior Regulatory Affairs Specialist - Lingo (on-site)Alameda, CA$90,000–$180,000 / yearIn this role, you will provide regulatory input on design and development activities to cross-functional teams, including software development and systems engineering members, and ensure availability of documentation to support submission activities to meet program objectives and timelines. Represent Regulatory Affairs on cross functional project teams and provide strategic input and technical guidance on product lifecycle planning and regulatory requirements for Class II software medical devices.
Senior Regulatory Affairs Specialist HyperfineSenior Regulatory Affairs SpecialistPalo Alto, CA$145,000–$167,000 / yearHyperfine, Inc. (Nasdaq: HYPR) is the groundbreaking health technology company that has redefined brain imaging with the Swoop ® system—the first FDA-cleared, portable, ultra-low-field, magnetic resonance brain imaging system capable of providing imaging at multiple points of care in a healthcare facility. Assess and advise regulatory strategies to optimize business expectations related to domestic and international commercial product availability and regulations: Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions.
Regulatory Affairs Specialist 4 IconmaRegulatory Affairs Specialist 4Sunnyvale, CA$53.65–$58.65 / hourRequirements:Minimum 8 years of regulatory affairs experience working in a medical device company (can be in combination with a regulatory affairs master degree; e.g., Masters in Regulatory Science). Regulatory working knowledge of product lifecycle management, design controls, risk management, verification and validation, and product labeling requirement.
Senior Regulatory Affairs Specialist – Lingo (on-site) AbbottSenior Regulatory Affairs Specialist – Lingo (on-site)Alameda, CaliforniaIn this role, you will provide regulatory input on design and development activities to cross-functional teams, including software development and systems engineering members, and ensure availability of documentation to support submission activities to meet program objectives and timelines. Represent Regulatory Affairs on cross functional project teams and provide strategic input and technical guidance on product lifecycle planning and regulatory requirements for Class II software medical devices.
Regulatory Affairs Specialist (NMPA) Intuitive Surgical IncRegulatory Affairs Specialist (NMPA)Sunnyvale, CACertain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government's licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan ("TCP") (note: typically adds 2 weeks to the hiring process). U.S. Export Controls Disclaimer: In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employees who are nationals from countries currently on embargo or sanctions status.
Principal Regulatory Affairs Specialist - Diabetes Care (on-site) Abbott LaboratoriesPrincipal Regulatory Affairs Specialist - Diabetes Care (on-site)Alameda, CA$100,000–$200,000 / 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. The individual may monitor and influence changing regulations and guidance, interface with outside regulatory agencies and trade associations, develop innovative regulatory submission strategy, and provide executive management with regulatory metrics/information.
Principal Regulatory Affairs Specialist - Diabetes Care (on-site) AbbottPrincipal Regulatory Affairs Specialist - Diabetes Care (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. The individual may monitor and influence changing regulations and guidance, interface with outside regulatory agencies and trade associations, develop innovative regulatory submission strategy, and provide executive management with regulatory metrics/information.
Principle Regulatory Affairs Specialist - Diabetes Care (on-site) Abbott LaboratoriesPrinciple Regulatory Affairs Specialist - Diabetes Care (on-site)Alameda, CA$100,000–$200,000 / 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. The individual may monitor and influence changing regulations and guidance, interface with outside regulatory agencies and trade associations, develop innovative regulatory submission strategy, and provide executive management with regulatory metrics/information.
Senior Regulatory Affairs Specialist (Onsite/Remote) EBR Systems IncSenior Regulatory Affairs Specialist (Onsite/Remote)Sunnyvale, CARemote$115,500–$156,400 / yearReviews and approves document change orders, advertising and promotional material, technical documents, test protocols and reports, risk management documents, labeling documents, and other documents as a key member of assigned project teams and ongoing sustaining support. In conjunction with project teams and international partners, evaluates possible pathways to marketing authorization and recommends pathway that appropriately weighs the probability of success with potential risks to the business.
Senior Regulatory Affairs Specialist LancesoftSenior Regulatory Affairs SpecialistSanta Clara, CA$43.80Proactively manages the changing regulatory environment for company products, prevents barriers to trade, eliminates duplication of effort and identifies and mitigates areas of risk. Prepares document packages for regulatory submissions for new and mature products to ensure alignment and compliance with local and regional registration requirements and company policies as required.
Staff Regulatory Affairs Specialist - Pleasanton, CA Calyxo IncStaff Regulatory Affairs Specialist - Pleasanton, CAPleasanton, CA$160,000–$175,000 / yearIn This Role, You Will: 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. As 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 commercializationbalancing speed with compliance as we bring category-defining medical devices to market.
Senior Regulatory Affairs Specialist - Vascular (on-site) Abbott LaboratoriesSenior Regulatory Affairs Specialist - Vascular (on-site)Santa Clara, CAIf you provide content to customers through CloudFront, you can find steps to troubleshoot and help prevent this error by reviewing the CloudFront documentation. Generated by cloudfront CloudFront Request ID: TwCqpv6BvTS-vlIXPJgAp7ukNfx9zn63Emu1GvSBFUGz6uk2CLaUZw.
Sr. Regulatory Affairs Specialist , Medical Devices Operational Compliance Center (MD-OCC) Amazon.com IncSr. Regulatory Affairs Specialist , Medical Devices Operational Compliance Center (MD-OCC)Sunnyvale, CAActs as a 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. The Quality & Lean, Medical Devices Operational Compliance Center (MD-OCC), consists of business process analysts, quality system experts, program managers, supply chain experts, regulatory experts, clinical affairs, and internal auditors.
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.
Staff Regulatory Affairs Specialist - Pleasanton, CA CalyxoStaff Regulatory Affairs Specialist - 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.
Senior Program Director, Commercial Regulatory Affairs IT EngagementsSenior Program Director, Commercial Regulatory AffairsSouth San Francisco, CA$100Role: Senior Clinical Program Director, Commercial Regulatory Affairs (Contract role) Location: San Francisco, CA Position Summary Commercial Regulatory Affairs (CORA) is part that interprets the needs of worldwide health authorities and provides regulatory intelligence necessary to generate and present information that meets the needs of health authorities, patients, purchasers and prescribers for Client's global Pharma Division, which includes all therapeutic areas and all phases of product development from early development to post marketing. Must demonstrate in-depth knowledge of the bio/pharma industry (compliance, legal, clinical affairs, regulatory and product marketing) as well as in-depth knowledge of the legal and regulatory environment, as it relates to healthcare compliance in the bio/pharma industry (includes anti-kickback statutes, government fraud & abuse, off-label promotion, PhRMA Code, etc.) .
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.
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.
Senior Regulatory Affairs CMC Associate Iovance Biotherapeutics IncSenior Regulatory Affairs CMC AssociateSan Carlos, CARemote$140,000–$160,000 / yearWorks with submission authors and reviewers to ensure that source document planning is complete and that high-quality documents are approved on-schedule in terms of scientific content, organization, clarity, accuracy, format, consistency and adherence to regulatory guidelines, styles and processes. Mental: 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.
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.
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 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.
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 Program Director, Commercial Regulatory Affairs SGA Inc.Senior Program Director, Commercial Regulatory AffairsSouth San Francisco, CAResponsibilities : Commercial Regulatory Affairs (CORA) is part that interprets the needs of worldwide health authorities and provides regulatory intelligence necessary to generate and present information that meets the needs of health authorities, patients, purchasers and prescribers for the firm's global Pharma Division, which includes all therapeutic areas and all phases of product development from early development to post marketing. Must demonstrate in-depth knowledge of the bio/pharma industry (compliance, legal, clinical affairs, regulatory and product marketing) as well as in-depth knowledge of the legal and regulatory environment, as it relates to healthcare compliance in the bio/pharma industry (includes anti-kickback statutes, government fraud & abuse, off-label promotion, PhRMA Code, etc.).
NewPublic Affairs Specialist - City Manager's Office (Communications & Legislative Affairs Office) City of FremontPublic Affairs Specialist - City Manager's Office (Communications & Legislative Affairs Office)Fremont, CA$91,256.65–$110,923.06 / yearAbility to: Prepare and present clear, concise, and accurate oral and written reports, statements, speeches, talking points, and presentations; plan, organize, and implement duties and responsibilities defined by desired outcomes and objectives; develop and implement projects and processes designed to enhance community relations at the block, neighborhood and city-wide level; develop and maintain effective working relationships with individuals from a variety of ethnic and socio-economic backgrounds; observe a variety of problems, identify core issues, and participate in the development of plans to address core issues; work cooperatively with other City departments and other agencies to leverage the use of community resources; plan, organize, and conduct large and small public meetings; develop and maintain cooperative relationships with neighborhood and community groups and City staff; facilitate problem solving among different parties with varying interests; respond to and effectively prioritize multiple requests for service; work irregular duty hours, nights, evenings, weekends and some holidays as required. Knowledge of: Principles, practices, and methods of various forms of mass media including but not limited to Internet, social media, print, television and radio, electronic communications and community engagement programs; problem solving techniques, working with graphic design software and digital media tools, writing, editing and techniques of team building, conflict resolution techniques, processes used in collaborative decision making, consensus building, and meeting facilitation; communication principles and practices; crime prevention principles and practices; emergency management training programs; fire safety, emergency preparedness and community organizations and agencies.
Regulatory Affairs Associate Jess BusheyRegulatory Affairs AssociateMountain View, California$80,000Ultimate Staffing Services is actively seeking a dedicated and detail-oriented Regulatory Affairs Associate to join a reputable medical device manufacturer. Coordinate, prepare, compile, and maintain regulatory documentation for local and regional registration, license renewal, and product submissions.
Regulatory 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.
Legal Affairs Specialist Alameda Health SystemLegal Affairs SpecialistOakland, CA$31.20–$51.97 / hourFinal compensation will be determined based on several factors, including but not limited to a candidate’s experience, education, skills, licenses and certifications, departmental equity, applicable collective bargaining agreements, and the operational needs of the organization. 4. Coordinates completion of insurance applications, facilitates communications with outside insurers for submission of data, and other necessary activities relating to the insurance programs of the health system as directed by the General Counsel.
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?
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).
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.
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.
Senior Regulatory Affairs Director - Oncology Cell & Gene Therapy AstraZeneca PlcSenior Regulatory Affairs Director - Oncology Cell & Gene TherapySouth San Francisco, CA$218,058.40–$327,087.60 / yearWorking with colleagues across locations, therapy areas and external partners, this role offers the chance to influence strategy end-to-end, from early development through rapid global approvals, while learning from leading experts, sharing best practices and using data, technology and modern approaches to reduce barriers for patients worldwide. Competitive salary and benefits package on offer: Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week.
Associate Director, Regulatory Affairs Project Planning & Coordination Acadia Pharmaceuticals IncAssociate Director, Regulatory Affairs Project Planning & CoordinationSan Francisco, 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.
Associate Director, Regulatory Affairs Iovance Biotherapeutics IncAssociate Director, Regulatory AffairsSan Carlos, CARemote$170,000–$200,000 / yearCollaborates closely with functional leaders to 1) create the optimal development path for Iovance product candidates, 2) negotiate optimal development paths within cross-functional teams and with health authorities, 3) execute clinical-regulatory development plans on-time and while managing all identified risks. Mental: Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to manage work-related stress; ability to manage multiple priorities simultaneously; and ability to meet deadlines.
NewAssociate Director, Regulatory Affairs Cytokinetics IncAssociate Director, Regulatory AffairsSouth San Francisco, CA$200,700–$234,150 / yearCytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction. Reporting to the Executive Director, Regulatory Affairs, the Associate Director, Regulatory Affairs, is responsible for hands-on regulatory activities across development stages, ensuring high-quality submissions and effective interactions with health authorities.