NewRegulatory Affairs Specialist DGN Technologies IncRegulatory Affairs SpecialistSunnyvale, CA$50–$60 / hourContractorp tabindex="0">• Strong 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.
NewSr. Regulatory Affairs - Contract TalentBurst, Inc.Sr. Regulatory Affairs - ContractSunnyvale, CAStrong 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.
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.
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.
Manager, Regulatory Affairs CMC Iovance Biotherapeutics IncManager, Regulatory Affairs CMCSan Carlos, CARemote$140,000–$160,000 / yearp>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. 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.
NewManager, 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.
NewRegulatory 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 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.
Regulatory Affairs Manager - International Compliance Operations – Diabetes Care (on-site) AbbottRegulatory Affairs Manager - International Compliance Operations – Diabetes Care (on-site)Alameda, CaliforniaLearn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Maintains expert working knowledge of laws, regulations and enforcement decisions related to Quality Assurance (QA), manufacturing and Research & Development (R&D) issues that may impact company operations and decision making; communicates such knowledge to all internal stakeholders.
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, 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, Regulatory Affairs Revolution Medicines IncSenior Manager, 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. The Opportunity: The Senior Manager of Regulatory Affairs will provide project teams with regulatory advice, manage and coordinate various Regulatory Affairs activities within and between departments, and obtain and maintain National Health Authority approvals for investigational products.
SENIOR MANAGER, REGULATORY AFFAIRS Sutro Biopharma IncSENIOR MANAGER, REGULATORY AFFAIRSSouth San Francisco, CA$153,000–$175,000 / yearp>Position 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, 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.
Regulatory Affairs Manager Actalent IncRegulatory Affairs ManagerSouth San Francisco, CA$60–$96 / hourSupport regulatory activities related to special regulatory designations, including Orphan Drug Designation (ODD), Fast Track, Breakthrough Therapy Designation (BTD), PRIME, and similar programs. Maintain complete and accurate regulatory archives and trackers, including monthly FDA submission records for all INDs and global health authority communications, and coordinate with partners to ensure archival completeness.
Senior Manager, Regulatory Affairs Hyperfine IncSenior Manager, Regulatory AffairsPalo Alto, CA$162,000–$186,000 / yearp>Hyperfine, 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. The Senior Manager, Regulatory Affairs owns and executes U.S. and international regulatory strategy for the company's Class II MRI devices and Class I accessory devices across the product lifecycle-from development through commercialization and post-market change management.
Manager, Regulatory Affairs & Market Development Bidgely Inc.Manager, Regulatory Affairs & Market DevelopmentLos Altos, CARemote$140,000p style="margin-top:12pt;margin-bottom:12pt;padding-left:24px">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. You will: Serve as a regulatory subject-matter expert for internal teams, providing context and interpretation of regulatory developments across markets.
NewSr Manager, Regulatory Affairs CMC GileadSr Manager, Regulatory Affairs CMCSan Mateo, CA$157,590–$203,940 / yearp>Undergraduate or advanced degree in life sciences or related field with significant CMC, manufacturing, research, development, regulatory or related work experience in the biopharma or related industry with at least 8 years of experience with a BA/BS, or 6 years with an MA/MS/MBA, or 2 years with a PhD or PharmD. Responsible for preparing and submitting complex regulatory documents which require interaction with departments outside of CMC Regulatory Affairs for investigational and commercial products, in line with ICH requirements, regional requirements, and scientific and company policies and procedures.
Senior Manager Regulatory Affairs contract Alumis IncSenior Manager Regulatory Affairs contractSouth San Francisco, CA$165,000–$195,000 / yearp>EDUCATION/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.
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 F. Hoffmann-La Roche LtdRegulatory Affairs ManagerCA$106,000–$197,000 / yearli>You have 3-5 years experience with PhD degree, 5-7 with Masters degree and 6-8 years with Bachelor degree in the field of IVDs/Medical devices/Pharma/Biopharmaceutical with significant experiences in Regulatory Affairs or equivalent. You understand the structure, key roles and responsibilities of external customers/stakeholders and communicate timely and effectively the needs of external customers/stakeholders.
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.
NewSenior Manager, Regulatory Affairs Hyperfine | AI-Powered Portable MRISenior Manager, Regulatory AffairsPalo Alto, CA$162,000–$186,000 / yearp>Hyperfine, Inc. 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 brainimaging system capable of providing imaging at multiple points of care in a healthcare facility. The Senior Manager, Regulatory Affairs owns and executes U.S. and international regulatory strategy for the company's Class II MRI devices and Class I accessory devices across the product lifecycle—from development through commercialization and post-market change management.
NewSenior Manager, Regulatory Operations NurixSenior Manager, Regulatory OperationsBrisbane, CALeveraging Nurix's extensive expertise in E3 ligases together with its proprietary DNA-encoded libraries, Nurix has built DELigase, an integrated discovery platform to identify and advance novel drug candidates targeting E3 ligases, a broad class of enzymes that can modulate proteins within the cell. Nurix's wholly owned pipeline comprises targeted protein degraders of Bruton's tyrosine kinase (BTK), a B-cell signaling protein, and an inhibitor of Casitas B-lineage lymphoma proto-oncogene-B (CBL-B), an E3 ligase that regulates T cell activation.
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.
NewRegulatory Affairs Manager – Diabetes Care (on-site) AbbottRegulatory Affairs Manager – Diabetes Care (on-site)Alameda, Californiali>Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree. Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews.
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.
Senior Manager, Regulatory CMC Vera Therapeutics IncSenior Manager, Regulatory CMCBrisbane, CA$140,000–$214,000 / yearVera Therapeutics' lead product candidate is atacicept, a fusion protein self-administered at home as a subcutaneous once weekly injection that blocks both B-cell Activating Factor (BAFF) and A Proliferation-Inducing Ligand (APRIL), which stimulate B cells to produce autoantibodies contributing to certain autoimmune diseases, including IgA nephropathy (IgAN) and lupus nephritis. Vera Therapeutics' receipt or acceptance of an unsolicited resume submitted by a vendor organization to this website or employee does not constitute an actual or implied contract between Vera Therapeutics and such organization and will be considered unsolicited and Vera Therapeutics will not be responsible for related fees.
Regulatory Manager | SQF Practitioner Taylor Farms PacificRegulatory Manager | SQF PractitionerTracy, CA$100,000–$120,000li>Develop, maintain, and update Product Specifications, Certificates of analysis, Nutritional Information, Production Batch Control Sheets, Product Labels, and Technical Bulletins, while also communicating and reflecting changes across Kiptraq, SharePoint, and other online tools. Collaborate with Purchasing and Supply Chain to approve ingredients, assess food safety risks, and address labeling regulations, while also comprehending the effects of factors like raw material quality, production processes, product quality and shelf life.
Manager, Regulatory Response Google LLCManager, Regulatory ResponseCAAs a Manager on the Regulatory Response Team, you will work closely with members of Global Affairs and act as a team lead for a team of project managers that partner with counsel, to coordinate how Google responds to inquiries and investigations by government and regulatory agencies worldwide. As a Program Manager at Google, you'll lead complex, multi-disciplinary projects from start to finish - working with stakeholders to plan requirements, manage project schedules, identify risks, and communicate clearly with cross-functional partners across the company.
Manager, Regulatory and Market Affairs Pattern Energy Group LPManager, Regulatory and Market AffairsSan Francisco, California$103,000–$138,000 / yearp style="margin:0px">A 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.
Project Manager - Regulatory and Licensing Stanford Health CareProject Manager - Regulatory and LicensingPALO ALTO, CA$66.52–$88.14 / hourAs a Project Manager - Regulatory & Licensing, you'll manage the licensing and regulatory coordination for healthcare projects, partnering closely with internal medical planning and regulatory affairs teams, external design teams, and authorities having jurisdiction. The Design and Construction Project Manager is responsible for managing the day-to-day efforts related to programming, planning, design, construction, and activation of small projects for the Stanford Health Care (SHC) under the general supervision of the Director.
Regulatory Affairs Manager - International Compliance Operations - Diabetes Care (on-site) Abbott LaboratoriesRegulatory Affairs Manager - International Compliance Operations - Diabetes Care (on-site)Alameda, CAp>If 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: HApWOKJEzq0IQxi15tNrlpXMJkFtE7qhBCo6PVler_t91rUjMytuOw.
Manager, ADS Safety Case, Regulatory Rivian Automotive IncManager, ADS Safety Case, RegulatoryPalo Alto, CA$186,000–$232,500 / yearRivian may use your Candidate Personal Data for the purposes of (i) tracking interactions with our recruiting system; (ii) carrying out, analyzing and improving our application and recruitment process, including assessing you and your application and conducting employment, background and reference checks; (iii) establishing an employment relationship or entering into an employment contract with you; (iv) complying with our legal, regulatory and corporate governance obligations; (v) recordkeeping; (vi) ensuring network and information security and preventing fraud; and (vii) as otherwise required or permitted by applicable law. Rivian may share your Candidate Personal Data with (i) internal personnel who have a need to know such information in order to perform their duties, including individuals on our People Team, Finance, Legal, and the team(s) with the position(s) for which you are applying; (ii) Rivian affiliates; and (iii) Rivian's service providers, including providers of background checks, staffing services, and cloud services.
Manager, Regulatory and Market Affairs Pattern Energy Group IncManager, Regulatory and Market AffairsSan Francisco, CA$103,000–$138,000 / yearp>A 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.
Regulatory Systems Manager Ardelyx IncRegulatory Systems ManagerNewark, CA$117,000–$143,000 / yearThis role will ensure regulatory information and documentation are maintained accurately and efficiently across systems that support regulatory submissions, health authority interactions, and product lifecycle management. The Regulatory Systems Manager will play a key role in improving processes, ensuring data integrity, supporting system implementations, configuration, or upgrades, and enabling efficient regulatory submissions and compliance.
NewSenior Manager, ADS Safety Case & Global Regulatory Strategy RivianSenior Manager, ADS Safety Case & Global Regulatory StrategyPalo Alto, California$173,000–$216,300 / yearul style="margin-top: 0; margin-bottom: 0;">Enabling Deployment: By developing credible, evidence-based safety cases supporting governmental approvals, you directly enable the commercialization and deployment of Rivian’s L3/4 autonomous systems on public roads.. Regulatory Trust: As a primary technical expert for regulators, you build the transparency and trust necessary for Rivian to navigate complex, evolving global approval processes..
Legal Engineering Manager, In-House (Litigation/Regulatory) Counsel AI CorpLegal Engineering Manager, In-House (Litigation/Regulatory)San Francisco, CA$315,000–$385,000 / yearIn addition to managing and developing the team, you will work directly with strategic customers, help shape Harvey's go-to-market approach, and partner cross-functionally with Product, Marketing, Enablement, and Engineering to improve how Harvey serves the legal industry. Qualified lawyer with 7+ PQE, including significant experience practicing litigation, regulatory, investigations, compliance, white-collar defense, enforcement, employment litigation, financial regulatory matters, government investigations, or other contentious legal work, including experience working in-house.
NewSenior Manager, ADS Safety Case & Global Regulatory Strategy Rivian Automotive IncSenior Manager, ADS Safety Case & Global Regulatory StrategyPalo Alto, CA$173,000–$216,300 / yearRivian may use your Candidate Personal Data for the purposes of (i) tracking interactions with our recruiting system; (ii) carrying out, analyzing and improving our application and recruitment process, including assessing you and your application and conducting employment, background and reference checks; (iii) establishing an employment relationship or entering into an employment contract with you; (iv) complying with our legal, regulatory and corporate governance obligations; (v) recordkeeping; (vi) ensuring network and information security and preventing fraud; and (vii) as otherwise required or permitted by applicable law. Rivian may share your Candidate Personal Data with (i) internal personnel who have a need to know such information in order to perform their duties, including individuals on our People Team, Finance, Legal, and the team(s) with the position(s) for which you are applying; (ii) Rivian affiliates; and (iii) Rivian's service providers, including providers of background checks, staffing services, and cloud services.
Program Manager, Regulatory Program Management Office Google LLCProgram Manager, Regulatory Program Management OfficeCAAs a Program Manager in the Regulatory PMO, you will work closely with members of Regulatory Affairs and act as the central project manager in partnership with counsel, to coordinate how Google responds to inquiries and investigations by government and regulatory agencies worldwide. As a Program Manager at Google, you'll lead complex, multi-disciplinary projects from start to finish - working with stakeholders to plan requirements, manage project schedules, identify risks, and communicate clearly with cross-functional partners across the company.
Senior Program Manager, Regulatory Program Management Office Google LLCSenior Program Manager, Regulatory Program Management OfficeCAp>As a Program Manager in the Regulatory PMO, you will work closely with members of Regulatory Affairs and act as the central project manager in partnership with counsel, to coordinate how Google responds to inquiries and investigations by government and regulatory agencies worldwide. As a Program Manager at Google, you'll lead complex, multi-disciplinary projects from start to finish - working with stakeholders to plan requirements, manage project schedules, identify risks, and communicate clearly with cross-functional partners across the company.
Regulatory Senior Manager - EPR The Clorox CoRegulatory Senior Manager - EPROakland, CA$128,000–$252,200 / yearThe position resides within the Strategic Regulatory group in the Legal & External Affairs function and serves as the enterprise lead for interpretation and assessment of EPR regulatory requirements that impact Clorox's products and packaging. 8+ years of relevant experience in regulatory affairs, product stewardship, compliance, or a related technical/regulatory function within consumer products, manufacturing, or another regulated industry.
Regulatory Affairs Manager - Diabetes Care (on-site) Abbott LaboratoriesRegulatory Affairs Manager - Diabetes Care (on-site)Alameda, CA$114,000–$228,000 / yearp>As a member of the U.S. Regulatory Affairs management team, the successful candidate will lead and develop talent, shape regulatory strategy, and partner across functions to bring innovative products to market, whilst driving regulatory excellence for the manufacture, change management, and ongoing supply of the Libre portfolio. Drive and provide strategic guidance on FDA pathways, submissions, and interactions, including pre-submissions, 510(k), PMA, and post-market activities.
Sr. Manager/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.
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.
Vice President, Regulatory and Head of Regulatory Affairs Sagimet Biosciences IncVice President, Regulatory and Head of Regulatory AffairsSan Mateo, CA$340,000–$370,000 / yearThis role will serve as the primary liaison with global regulatory authorities and involve close collaboration with Sagimets cross-functional teams and external partners, to ensure the successful advancement of our clinical programs. Oversee the companys external regulatory advisors, consultants and vendors to ensure that relevant regulatory advice is provided with respect to the companys development programs.
NewSenior Program Director, Commercial Regulatory Affairs Nesco Resource, LLCSenior Program Director, Commercial Regulatory AffairsSouth San Francisco, CA$73.32–$179 / hourThis position leads Program Review Committees (PRCs), develops regulatory strategies, partners with cross-functional business leaders, and serves as the primary regulatory decision-maker supporting pharmaceutical advertising, promotion, product launches, and FDA communications. This role supports the U.S. Commercial Regulatory Affairs organization and works across therapeutic areas and product portfolios to ensure promotional materials and regulatory submissions comply with FDA regulations, healthcare compliance requirements, and company policies.
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.
Regulatory Affairs Coordinator Public Health Foundation Enterprises, InRegulatory Affairs CoordinatorRichmond, CAFull timeKnowledge of current Good ClinicalPractices (cGCP), current Good Manufacturing Practices (cGMP), Good Documentation Practices and a strong understanding of FDA regulations and guidelines. Participate in review of BabyBIG documentation to support highest possible quality of all records produced by manufacturing contractors or contracting research organizations .