Specialist Regulatory Compliance Environmental American Tower CorpSpecialist Regulatory Compliance EnvironmentalWoburn, MAThis team ensures the appropriate level of environmental review is completed to address the FCC's National Environmental Policy Act's ("NEPA") compliance requirements and the Comprehensive Environmental Response Compensation and Liability Act's ("CERCLA") due diligence considerations for wireless facility development and redevelopment. Contribute to monthly team meetings focused on project review trends, environmental services trends, cross-functional training needs, and customer service best practices.
NewSenior LOB Risk Specialist - Regulatory Reporting and Internal Controls PNC BankSenior LOB Risk Specialist - Regulatory Reporting and Internal ControlsPittsburgh, PennsylvaniaServe as the primary LOB contact to support and advise management in their effort to manage risk and controls effectively as they relate to FGO in-scope programs by understanding their LOB and bringing in FGO Reporting Risk subject matter expertise and process excellence. In addition, PNC generally provides the following paid time off, depending on your eligibility: maternity and/or parental leave; up to 11 paid holidays each year; 9 occasional absence days each year, unless otherwise required by law; between 15 to 25 vacation days each year, depending on career level; and years of service.
Senior Regulatory Technical Specialist Hanford Tank Waste OperationsSenior Regulatory Technical SpecialistRichland, WAThe C&IM organization is in search of a Senior-level Regulatory Technical Specialist (Specialist) to support the strategic planning, performance, and reporting of technical evaluations associated with facility closure, interim measures, and correction actions for soil contamination, tank waste residuals, and contaminated equipment in tank farm areas. Must demonstrate the following minimum experience on the listed activities: * 12-years' experience: planning, implementing, managing, and overseeing environmental characterization projects to support Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) and Resource, Conservation, and Recovery Act (RCRA).
NewRegional Director of Clinical and Regulatory Support Community Hospital CorporationRegional Director of Clinical and Regulatory SupportPlano, TXFull timeUnder the supervision of the VP of Clinical Services for Post-Acute Services, the Regional Director of Clinical and Regulatory support: Supports clinical and quality initiatives for owned, managed, and consulting facilities by providing support to field CNO’s and DQMs; Serves as the infection control specialist for post-acute services and is responsible for developing, implementing and coordinating a consistent approach to infection prevention and control; Supports Regulatory compliance and provides regulatory support for owned, managed and consulting facilities; Serves as a lead for mock surveys; Serves in interim CNO and DQM roles as requested by the VP Clinical Services; and. Community Hospital Corporation (CHC), recently recognized as a 2026 Dallas Morning News Top Workplace and named to Becker’s list of 165 Top Places to Work in Healthcare, is seeking a Regional Director of Clinical and Regulatory Support for our Post-Acute hospitals.
Payroll Specialist Kforce Inc.Payroll SpecialistFenton, MO$50,000–$70,000Summary: This is an excellent opportunity to join a stable organization with a collaborative team environment where you'll play a key role in processing payroll, ensuring compliance, and supporting accounting operations. By clicking “Apply Today” you agree to receive calls, AI-generated calls, text messages or emails from Kforce and its affiliates, and service providers.
NewLoan Servicing Specialist I Peoples Security Bank & Trust CompanyLoan Servicing Specialist IMoosic, PAWhile performing the essential job functions of this position, the employee is regularly required to sit, stand, talk, hear, walk, use hands and fingers, handle or feel objects, and reach with hands and arms. Peoples Security Bank & Trust Company is seeking a Loan Servicing Specialist to support the full lifecycle of our commercial, consumer, and real estate loan portfolios.
NewPer Diem / PRN Nurse RN - Clinical Document Improvement Specialist - $37-56 per hour United Health ServicesPer Diem / PRN Nurse RN - Clinical Document Improvement Specialist - $37-56 per hourBinghamton, NY$37–$56 / hourThe Clinical Documentation Improvement (CDI) Specialist-RN is a registered nurse responsible for performing concurrent and retrospective reviews of inpatient medical records to ensure complete, accurate, and compliant clinical documentation. This role works closely with providers, coders, and quality teams to clarify documentation and support accurate data capture for clinical, financial, and regulatory reporting.
Specialist Quality Assurance, Regulatory Affairs And Work Environment Management DBA: Zeiss GroupSpecialist Quality Assurance, Regulatory Affairs And Work Environment ManagementStockholm, METhe role Specialist Quality Assurance, Regulatory Affairs and Work Environment Management of will involve: Maintain, develop, and evaluate the ZEISS Nordics Quality Management System across all Nordic sites. In the Nordics, ZEISS has direct sales and service representation in all four countries and employs a network of Account Managers, Product and Applications Specialists and a strong Field Service team.
Regulatory Affairs Specialist Patterson Companies IncRegulatory Affairs SpecialistSt Paul, MN$77,200–$100,333.33 / yearStrong verbal and written communications with ability to effectively communicate at specialist and line management levels in the organization; strong customer service-oriented skills. Ability to work effectively within a team and as an individual contributor in a fast-paced changing environment -- multi-tasks, prioritizes and meet deadlines in timely manner.
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.
Intrnatl Regulatory Specialist Globus MedicalIntrnatl Regulatory SpecialistAudubon, PennsylvaniaThis individual must be enthusiastic, positive, even-tempered and effective in building working relationships with cross-functional teams and international staff while following ISO, CE, FDA and international/local regulations. Partners with Product Development, Quality Assurance, and management to prepare and review international Regulatory submissions, including CE technical files, and other international filings, to obtain marketing clearance.
Regulatory & Compliance Specialist CorDxRegulatory & Compliance SpecialistSan Diego, CA$90,000–$95,000 / yearWith over 2,100 employees across the world, serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious disease such as COVID-19, pregnancy, drugs of abuse, biomarkers, and more. CorDx is at the cutting edge of technology, artificial intelligence, and data science with the goal of delivering diagnostic solutions to some of the most critical questions in healthcare.
Sr. Specialist, Regulatory Ferrara Candy Company IncSr. Specialist, RegulatoryChicago, IL$80,325–$112,455 / yearThis role is responsible for supporting complex and innovative projects through ingredient approval, formulation review, label copy development and maintenance, claim substantiation, and artwork review, helping ensure products are compliant, market-ready, and positioned for successful launch and ongoing support. The Senior Regulatory Specialist will make a meaningful impact on Ferraras product innovation and brand stewardship by providing expert regulatory guidance across a diverse portfolio of U.S. Iconic, Seasonal, and Jelly Belly confectionery and dietary supplement products.
Regulatory Compliance Specialist - Transplant Center Houston Methodist HospitalRegulatory Compliance Specialist - Transplant CenterHouston, TXAt Houston Methodist, the Regulatory Compliance Specialist position is responsible for coordinating and performing study specific regulatory processes such as local IRB submissions in compliance with Good Clinical Practices (GCP) and all local, state, and federal laws, regulations, guidance, policy and procedure developed by Houston Methodist Research Institute Institutional Review Board (IRB), Food and Drug Administration (FDA) Code of Federal Regulations (CFR), and the International Conference on Harmonization (ICH). Houston Methodist Research Institute supports research programs and infrastructure that enable faculty across the system to bring new scientific discoveries to patients as rapidly as possible through the full cycle of a cure from conceptual bench research, to prototyping and development, to clinical trials and FDA approval.
NewRegulatory Operations Specialist Caldera Medical IncRegulatory Operations SpecialistWestlake Village, CARequired Knowledge, Skills and Abilities: 1-3 years in regulatory operations, regulatory affairs, document control, quality, or a related medical device function - or a strong adjacent data/administrative role with regulatory exposure. Maintain the master registration matrix and renewal tracker (license/registration data, classifications, license holder, expiry dates, certificate links), updating weekly from RA Specialists, contractors, and ARs.
NewDirector Of Regulatory Affairs - Remote UnitedHealth Group Inc.Director Of Regulatory Affairs - RemoteEden Prairie, MNRemote$134,600–$230,800 / yearWorking closely with their team, legal and compliance colleagues, and business stakeholders, the Director of Regulatory Affairs will lead or support a wide range of regulatory activities, including regulatory assessments for new product/therapies and changes to existing products and the development and the execution of regulatory plans/strategies as required. The Director of Regulatory Affairs will be a member of the Legal Team responsible for providing the enterprise with strategic counsel and support on regulatory and quality matters related to medical devices, including software and algorithms, and other digital health technologies.
Director, Regulatory Affairs (US Filing Lead) Revolution Medicines, Inc.Director, Regulatory Affairs (US Filing Lead)Redwood City, CA$211,000–$264,000 / 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. Required Skills, Experience and Education: Degree in life sciences, pharmacy, medicine, or related fields with a minimum of 12 years in the pharmaceutical/biotech industry or relevant work experience and a minimum of 8 years in Regulatory Affairs including a regulatory strategy role.
Director, Regulatory Affairs - US Filing Lead Revolution Medicines, Inc.Director, Regulatory Affairs - US Filing LeadRedwood City, CA$211,000–$264,000 / 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. Required Skills, Experience and Education: Degree in life sciences, pharmacy, medicine, or related fields with a minimum of 12 years in the pharmaceutical/biotech industry or relevant work experience and a minimum of 8 years in Regulatory Affairs including a regulatory strategy role.
NewAssociate Director, Regulatory Affairs Nuvation Bio, Inc.Associate Director, Regulatory AffairsRemote - Any State US, NYRemote$190,000–$200,000 / yearWe are looking for an experienced hands-on Regulatory Affairs professional to contribute to the development strategy and lead in the planning, preparation, submission and maintenance of regulatory submissions for Nuvation products. Our full-time regular positions also include an annual performance-based bonus and long-term incentive units (equity) provided as part of our compensation package, in addition to a full range of medical, financial, and/or other benefits, depending on the level and position offered.
Principal Regulatory Affairs Consultant Syner-GPrincipal Regulatory Affairs ConsultantFramingham, MAAs a Senior General Strategy Consultant, you will play a pivotal role in guiding clients through the complex landscape of regulatory affairs, ensuring compliance and facilitating the successful development and approval of pharmaceutical products. Syner-G was recently honored with BioSpace's prestigious "Best Places to Work" 2026 award, for the third consecutive year, along with many other award-winning programs to make a career here truly life-enhancing.
Claims Legal Specialist - Conditional Demands Sentry InsuranceClaims Legal Specialist - Conditional DemandsGoldsboro, NC$31.25–$37.50Experience in handling conditional demands, preferably including bodily injury claims, on behalf of an insurer as an attorney, technical specialist, claims manager or similar role sufficient in one more of the following states to develop a high degree of technical expertise: CA, FL, TX, GA, or SC. Act as a subject matter expert, provide technical advice, direction, and guidance to other claims associates as need arises including instruction and authority on all complex conditional settlement demands received by enterprise.
Associate Director, Regulatory Affairs CMC CRISPR TherapeuticsAssociate Director, Regulatory Affairs CMCSouth Boston, MassachusettsThe Company has evolved from a pioneering research-stage organization into an industry leader, marking a historic milestone with the approval of CASGEVY® (exagamglogene autotemcel [exa-cel]), the world’s first CRISPR-based therapy, approved for eligible patients with sickle cell disease and transfusion-dependent beta thalassemia. You will work in close collaboration with CMC and global development teams, and with relevant external parties including contract manufacturing organizations, expert consultants, development partners, and global health authorities.
Quality & Regulatory Affairs MindlanceQuality & Regulatory AffairsGlenview, ILRemoteThis position requires the ability to handle complexity, work independently, and manage multiple projects under tight timelines with a strong drive for results and the ability to bring projects to completion. " Investigates customer/consumer complaints using root cause analysis and works with department managers to determine what corrective and preventive actions are necessary.
Regulatory Affairs Lead Oncology Associate Director Astellas Pharma IncRegulatory Affairs Lead Oncology Associate DirectorNorthbrook, ILResponsibilities and Accountabilities: Actively seeks out knowledge of overall corporate strategy and other general factors that affect the regulatory positions taken within the company, and with the FDA and global health authorities, and incorporates this knowledge in interactions with others. Works closely with other individuals/groups within Regulatory Affairs to influence others to ensure departmental consistency and identifies options for risk discussions.
Manager Patient Safety Regulatory Affairs Boca Raton, Corp Quality & Accred Ops, FT, 8:30A-5P Baptist Health South Florida IncManager Patient Safety Regulatory Affairs Boca Raton, Corp Quality & Accred Ops, FT, 8:30A-5PCoral Gables, FL$112,081.46–$149,068.34 / yearBaptist Health is the region''s largest not-for-profit healthcare organization, with 12 hospitals, over 29,000 employees, 4,500 physicians and 200 outpatient centers, urgent care facilities and physician practices across Miami-Dade, Monroe, Broward and Palm Beach counties. Our approach is rooted in a "grow our own" philosophy, designed to help our team members build meaningful, long-term careers with us, supported by benefits that make a real difference, including: Career growth and development opportunities, with clear pathways and ongoing support.
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.
Regulatory Affairs Manager Macpower Digital Assets Edge Private LimitedRegulatory Affairs ManagerNew York, NY$43–$55 / hourSummary: The Regulatory Affairs Manager ensures regulatory compliance of The Avon/LG H&H US cosmetic, OTC, dietary supplement, and device products from brief through launch in North America. Specifically, the Manager will assemble and review all product-related information including formulas, specifications, and quality/regulatory compliance documentation, and for approving claims, labeling, and advertising.
Regulatory Affairs Director VitalConnect IncRegulatory Affairs DirectorCA$150,000–$175,000 / yearWrite, analyze, and edit technical documents to support country-specific regulatory submissions and compile submissions in a format consistent with applicable guidance documents, including device submissions in USA, Europe and other countries. Assure that appropriate maintenance of registrations occurs including renewals, device listings, site registrations, supplements for changes and annual reports.
Regulatory Affairs Coordinator (RN) WMCG Augusta Georgia WellstarRegulatory Affairs Coordinator (RN) WMCG Augusta Georgiaresponsible for the coordination of self-tracers, and for conducting process tracers including developing tracers, collecting, analyzing, and reporting tracer findings. Develops and delivers education regarding internally and externally driven trends in healthcare licensure, accreditation, and regulatory compliance.
Director, CMC Regulatory Affairs Recursion PharmaceuticalsDirector, CMC Regulatory AffairsNew York, NYRemote$228,250–$280,720 / yearPowered by proprietary multimodal data, purpose-built AI models, and bilingual teams fluent in both science and AI, the Recursion OS is designed to translate complex science into medicines that matter - faster, better, and at scale - for patients who are waiting. Recursion is advancing a portfolio of differentiated investigational medicines across its wholly owned and partnered pipeline in oncology, rare disease, neuroscience, immunology, and other therapeutic areas with significant unmet need.
Senior Manager, Regulatory Affairs Sutro Biopharma, Inc.Senior Manager, Regulatory AffairsSouth San Francisco, CA$153,000–$175,000 / yearPosition Overview: Sutro has a unique capability that enables new molecular entities to be designed using a hybrid of synthetic and recombinant technologies to create best in class therapeutics in the oncology and auto-immune disease space. Sutro is advancing a robust early-stage pipeline of novel exatecan and dual-payload antibody drug conjugates (ADCs), coupled with high-value collaborations and industry partnerships, which validate its continuous product innovation.
Director, Regulatory Affairs Centrus Energy CorpDirector, Regulatory AffairsOak Ridge, TNYou''ll ensure compliance with DOE, NRC, and applicable federal, state, and local requirements; develop and implement regulation based training programs; guide continuous improvement initiatives; represent Centrus with internal and external stakeholders; and build, mentor, and lead high-performing teams that support safe, reliable, and efficient operations. Knowledge of regulatory compliance programs such as; radiological safety programs; environmental and waste programs; root cause and corrective action programs, environmental and waste programs; industrial hygiene programs, industrial safety programs, and continuous improvement methodologies.
Regulatory Affairs Labeling Operations AI Innovation Co-op Boehringer IngelheimRegulatory Affairs Labeling Operations AI Innovation Co-opRidgefield, CT$20–$33 / hourIn the Regulatory Affairs Labeling Ops AI Innovation Co-Op role, your work will help modernize labeling operations through artificial intelligence, automation, and digital solutions—directly impacting how we deliver compliant, patient-centered labeling and regulatory content. This role is focused on utilizing artificial intelligence, automation tools, and digital solutions to modernize labeling operations workflows, drive greater accuracy, seamless system integration, and enhanced operational efficiency.
Regulatory Affairs Senior Manager LancesoftRegulatory Affairs Senior ManagerWarren, NJJob Purpose: The purpose of this role is to execute OTC regulatory activities for new product registrations and life-cycle Maintenance for the portfolio of products defined by the US Business Units. Provides advice on US-specific activities and ways of working and processes; Proactively identify potential risks and manage impact of regulatory changes within defined scope of.
Regulatory Affairs Labeling Operations AI Innovation Co-op Boehringer Ingelheim International GmbHRegulatory Affairs Labeling Operations AI Innovation Co-opRidgefield, CT$20–$33 / hourIn the Regulatory Affairs Labeling Ops AI Innovation Co-Op role, your work will help modernize labeling operations through artificial intelligence, automation, and digital solutions-directly impacting how we deliver compliant, patient-centered labeling and regulatory content. This role is focused on utilizing artificial intelligence, automation tools, and digital solutions to modernize labeling operations workflows, drive greater accuracy, seamless system integration, and enhanced operational efficiency.
Senior Director, Regulatory Affairs (Oncology) Exelixis IncSenior Director, Regulatory Affairs (Oncology)Alameda, CA$248,000–$352,500 / yearEDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS: Education/Experience: Bachelor's degree in related discipline and a minimum of fifteen years of related experience; or, Master's degree in related discipline and a minimum of thirteen years of related experience; or, PhD degree in related discipline and a minimum of twelve years of related experience; or, Equivalent combination of education and experience. Lead, author and evaluate documents submitted to regulatory health authorities to ensure they are complete, organized, of high quality, contain appropriate messaging and compliant with applicable regional regulations.
Manager, Regulatory Affairs Monte Rosa Therapeutics IncManager, Regulatory AffairsBoston, MAResearches and analyzes regulatory information and determines acceptability of data, procedures, and other product-related documentation presented in support of product registration. Under supervision, compiles regulatory submissions, license renewal and annual registrations to the US Food and Drug Administration (FDA) and other regulatory agencies.
NewQuality & Regulatory Affairs LanceSoft IncQuality & Regulatory AffairsGlenview, ILRemote$18–$20.59 / hourThis position requires the ability to handle complexity, work independently, and manage multiple projects under tight timelines with a strong drive for results and the ability to bring projects to completion. " Investigates customer/consumer complaints using root cause analysis and works with department managers to determine what corrective and preventive actions are necessary.
NewRegulatory 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.
Manager, Compliance and Regulatory Affairs SuvidaManager, Compliance and Regulatory AffairsTucson, ArizonaCoordinate system projects by partnering with accountable business owners and proactively lead efforts to mitigate risks associated with business activities, confirm risk measurement/s and business monitoring and align with internal and regulatory requirements. This includes creating a compliance strategy that ensures business accountability for oversight over the day-to-day monitoring of the business areas as well as supporting business partners in implementing that strategy.
Director, Regulatory & Administrative Affairs - Institute for Transformative Clinical Trials Mount Sinai Health SystemDirector, Regulatory & Administrative Affairs - Institute for Transformative Clinical TrialsNew York, NY$95,450–$143,175 / yearThe Director of Regulatory & Administrative Affairs for the Mount Sinai Institute for Transformative Clinical Trials provides strategic leadership and operational oversight for regulatory, safety, and administrative activities supporting a portfolio of sponsor-led, investigator-initiated, federally funded, and industry-sponsored clinical research studies. Mount Sinai advances health for all people, everywhere, by taking on the most complex health care challenges of our time - discovering and applying new scientific learning and knowledge; developing safer, more effective treatments; educating the next generation of medical leaders and innovators; and supporting local communities by delivering high-quality care to all who need it.
EHS Specialist - B44 MedlineEHS Specialist - B44Manteca, CA$73,000–$110,000 / yearPosition requires exposure to the environmental/atmospheric conditions: Indoor conditions, cold/hot temperature changes, wet, noise, vibration, fumes, odors, dust and mechanical / electrical / chemical hazards. Under general supervision, responsible for leading the implementation of Employee Health and Safety programs, policies, management systems and strategies in support of all facilities in assigned region.
Appeals and Grievance Regulatory Specialist Presbyterian Healthcare ServicesAppeals and Grievance Regulatory SpecialistReverend Hugh Cooper Administrative Center, NYUnder limited supervision, responds to and resolves complex issues related to daily operations, and overall management of the processes to meet regulatory and contractual requirements for oversight bodies of all product lines and to develop and create internal and external reports related to appeals and grievance data for member and providers of all product lines. Composes responses to RFPs for the health plan and other vendors, as well as commercial, PIC and Medicaid contracts as required and requested, based on data collected by appeals and grievance and complaint data processed in the department.
Director of Individual Insurance Compliance & Regulatory Affairs Alera GroupDirector of Individual Insurance Compliance & Regulatory AffairsChicago, IllinoisThe ideal candidate brings deep expertise in Medicare and individual insurance compliance, strong regulatory knowledge, and experience building scalable compliance frameworks within complex, multi-site insurance or healthcare environments. This role will lead the development, implementation, and oversight of scalable compliance programs supporting Medicare Advantage, Medigap, Part D, ACA, and ancillary insurance products across a national distribution platform.
Manager, Regulatory Affairs Strategy - Oncology Regeneron Pharmaceuticals IncManager, Regulatory Affairs Strategy - OncologyTarrytown, NY$128,600–$210,000 / yearDiscover your role: Coordinate the preparation, submission, management and maintenance of global regulatory submissions related to clinical and nonclinical aspects of product development, including, but not limited to, the following: INDs/CTAs, amendments and information requests, Orphan drug applications, Annual Reports and Investigator's Brochure. The Manager, Regulatory Affairs will report to the Global Regulatory Liaison (GRL) and provides support to the GRL in all aspects of regulatory affairs related to the development of novel therapeutics including quality, preclinical and clinical areas of drug development and the policies/procedures required to ensure compliance with regulations.
Regulatory Affairs Coordinator - VESPER The Henry M Jackson Foundation for the Advancement of Military Medicine IncRegulatory Affairs Coordinator - VESPERWashington, DCThe Regulatory Affairs Coordinator will support the center's human subjects research portfolio focused on environmental exposures and health outcomes, by preparing, submitting, and managing regulatory documentation; ensuring compliance with institutional, federal, and sponsor requirements; and assisting with study budget and supply management. This role is responsible for Institution Review Board (IRB) submissions, informed consent oversight, regulatory documentation management, supply tracking, ongoing study compliance, supply inventory, and study budget oversight.
Director Regulatory Affairs Data Standards and Governance AbbVie IncDirector Regulatory Affairs Data Standards and GovernanceNorth Chicago, ILSupport the Product Data Office initiative to establish enterprise-level data governance, improve data quality and interoperability to resolve key business challenges including Regulatory and Supply Chain data integration and Change Control processes. Builds and uses AbbVie's Data Catalogue to drive clear definitions for critical data elements, supporting data lineage verification and mapping properties across systems for interoperability of Regulatory data across the product lifecycle.
Director, Regulatory Affairs US Filing Lead Revolution Medicines IncDirector, Regulatory Affairs US Filing LeadRedwood City, CA$211,000–$264,000 / 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. Required Skills, Experience and Education: Degree in life sciences, pharmacy, medicine, or related fields with a minimum of 12 years in the pharmaceutical/biotech industry or relevant work experience and a minimum of 8 years in Regulatory Affairs including a regulatory strategy role.
Director, Regulatory Affairs - US Filing Lead Revolution Medicines IncDirector, Regulatory Affairs - US Filing LeadRedwood City, CA$211,000–$264,000 / 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. Required Skills, Experience and Education: Degree in life sciences, pharmacy, medicine, or related fields with a minimum of 12 years in the pharmaceutical/biotech industry or relevant work experience and a minimum of 8 years in Regulatory Affairs including a regulatory strategy role.
Director, Regulatory Affairs (US Filing Lead) Revolution MedicinesDirector, Regulatory Affairs (US Filing Lead)Redwood City, California$211,000–$264,000 / 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. Degree in life sciences, pharmacy, medicine, or related fields with a minimum of 12 years in the pharmaceutical/biotech industry or relevant work experience and a minimum of 8 years in Regulatory Affairs including a regulatory strategy role.