Medical Device Regulatory Specialist Google LLCMedical Device Regulatory SpecialistDCOur teams are applying our expertise and technology to improve health outcomes globally - with high-quality information and tools to help people manage their health and wellbeing, solutions to transform care delivery, research to catalyze the use of artificial intelligence for the screening and diagnosis of disease, and data and insights to the public health community. We work toward this vision by meeting people in their everyday moments and empowering them to stay healthy and partnering with care teams to provide more accurate and accessible care.
Senior Regulatory Affairs Specialist (Columbia, MD) Smith & Nephew PlcSenior Regulatory Affairs Specialist (Columbia, MD)Columbia, MD$101,500–$152,250 / yearThe Senior Regulatory Affairs Specialist will be responsible for projects by leading regulatory submissions and designing comprehensive regulatory strategies on Human Cells, Tissues, and Cellular and Tissue-Based products (HCT/P) projects as well as define regulatory strategies for new device-led combination products. Act as NPD regulatory lead on new device-biologics combination products and define regulatory strategy for FDA submissions including authoring FDA 510(k) submissions and FDA pre-submissions.
Regulatory Affairs Specialist US Department of Health and Human ServicesRegulatory Affairs SpecialistMontgomery County, MD$121,785–$158,322 / yearIn addition, to qualify for a Regulatory Affairs Specialist GS-0601 position at the GS-13 grade level, you must have: at least one (1) year of qualifying experience equivalent to at least the GS-12 level in the Federal service obtained in either the private or public sector, performing the following types of tasks: (1) Leading protocol navigation activities, including coordinating scientific review, Institutional Review Board (IRB) and/or Investigational New Drug (IND) submissions, addressing stipulations, and facilitating clinical trial protocol development processes; (2) Managing a clinical trials portfolio by liaising with investigators/ study teams, regulatory agencies, and sponsors; tracking reviews of all review bodies; and maintaining accurate essential regulatory documentation; (3) Developing regulatory documents such as protocols, consents, and associated components in accordance with federal regulatory requirements; (4) Providing regulatory expertise by analyzing complex issues, preparing safety, annual, and/or progress reports, and recommending strategies to ensure compliance and expedite review processes. Assist all aspects of the protocol lifecycle including scientific review, initial investigational new drug (IND) documents, institutional review board (IRB) submission of protocols, continuing review applications, protocol amendments, annual reports to other regulatory and safety bodies such as the Radiation Safety Committee (RSC) and the Institutional Biosafety Committee (IBC), and protocol inactivation.
Senior Regulatory Affairs Specialist PhilipsSenior Regulatory Affairs SpecialistDC$99,000–$157,000 / yearThe actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity. • Lead global regulatory intelligence initiatives, contribute to regulatory and product registration strategies, and help implement global regulatory roadmaps based on the competitive landscape and marketing objectives.
Senior Regulatory & Scientific Affairs Specialist (Remote) Nestle SASenior Regulatory & Scientific Affairs Specialist (Remote)Arlington, VARemote$99,500–$130,000 / yearIf you live within 50 miles of our Arlington, VA, headquarters, this will be a hybrid position currently requiring Tuesday-Thursday onsite This will support International Premium Waters Position Summary Apply experience and expertise of regulations & policies to review and apply compliance by design of (a) formulas, ingredients and any relevant processing procedures, (b) all required and optional label information, including claims, and (c) sensitive communications such as advertising, promotional materials, websites, etc. Must demonstrate strong verbal and written communications skills, along with strong influencing and negotiation skills, recognized expertise in functional areas with the ability to communicate regulatory and technical issues in lay terms.
Regulatory Specialist HealthfirstRegulatory SpecialistIN$68,900–$99,620 / yearCompliance is promoted ensuring regulatory updates are evaluated, implemented and by performing monitoring to evaluate compliance with regulatory requirements required by, Centers for Medicare and Medicaid Services (CMS) and State Department of Health (DOH) regulations, and business requirements. Relevant previous work experience and knowledge of Department of Health (DOH) and Local Department of Social Services and Center for Medicare & Medicaid Services (CMS) regulations pertaining to managed care; etc.
Regulatory Affairs Specialist - WHIRC The Henry M Jackson Foundation for the Advancement of Military Medicine IncRegulatory Affairs Specialist - WHIRCAnnandale, VAHJF is seeking a Regulatory Affairs Specialist-WHIRC to be responsible for assisting in the compliance of HJF research programs with applicable local, state and federal regulations for human subjects' research, animal use research, recombinant DNA, and Health Insurance Portability and Accountability Act (HIPAA). We serve military, medical, academic and government clients by administering, managing, and supporting preeminent scientific programs that benefit members of the armed forces and civilians alike.
Regulatory Specialist Ecological Restoration Resource Environmental Solutions LLCRegulatory Specialist Ecological RestorationAnnandale, VAWorking with our team consisting of project managers, ecologists, design, GIS, and construction managers, you will be drafting and compiling technical documents and reports for submittal to agency representatives. At RES, we're looking for purpose-driven individuals who are passionate about restoration and sustainability, and who want their work to make a lasting environmental impact.
Financial Regulatory Specialist DLA Piper LLP (US)Financial Regulatory SpecialistDC$88,383–$117,111 / yearp>While the specific job requirements of a DLA Piper position may vary depending upon scope of the job and area of specialty, there are certain universal requirements that are expected of all DLA Piper employees, which include but are not limited to: Effectively communicate, verbally and in writing, with clients, lawyers, business professionals, and third parties. This role combines financial services and regulation awareness, strong written communication skills, and cross-partner coordination to ensure regulatory developments and insights are clearly communicated and consistently delivered.
Regulatory Compliance Specialist Rain (United States)Regulatory Compliance SpecialistWashington, DCThe Regulatory Compliance team is responsible for ensuring that Rains products, operations, and customer-facing practices meet the requirements of applicable laws, regulations, and card network rules. The Regulatory Compliance Specialist will report directly to the Manager of Regulatory Compliance and will serve as a key contributor on card network rules compliance, consumer protection requirements, and complaint support.
NRO - P4511 - Municipal Separate Storm Sewer System (MS4) Regulatory Specialist Commonwealth of VirginiaNRO - P4511 - Municipal Separate Storm Sewer System (MS4) Regulatory SpecialistWoodbridge, VA$68,000–$92,000 / yearProficiency with Word, Excel, GIS, PowerPoint, and compliance tracking systems is essential, Ability to communicate technical and regulatory information clearly to diverse audiences, including regulated permittees. The position guides permittees in developing and maintaining compliant stormwater programs, interprets regulatory requirements, and supports statewide consistency in MS4 program administration.
Regulatory Specialist Stantec IncRegulatory SpecialistMDThis position will be part of Stantec's Environmental Services team that provides the full range of expertise needed to address a variety of projects, including but not limited to supporting to public utilities, new electric transmission and rebuild projects, project access road planning and design, substation and battery storage facility design, solar due diligence and environmental permitting. Preparing technical reports for and managing coordination with the Maryland Department of the Environment (MDE), MD Department of Natural Resources (MD DNR), US Army Corps of Engineers (USACE), US Fish and Wildlife Service (USFWS), Environmental Protection Agency (EPA), and other federal, state, and local agencies.
Associate Director, Regulatory Affairs US Lead, Regulatory Science & Execution AstraZeneca PlcAssociate Director, Regulatory Affairs US Lead, Regulatory Science & ExecutionGaithersburg, MD$135,624.80–$203,437.20 / yearThe Associate Regulatory Affairs Director, US Lead, Regulatory Science & Execution will be accountable for the development, implementation and maintenance of regulatory strategies for assigned project(s)/product(s) and regulatory jurisdiction(s), with the intention of achieving successful registration and lifecycle management of unique and technologically complex products serving patients with rare diseases and unmet medical needs. Providing strategic and tactical advice on regulatory issues for pipeline products; actively collaborates with management, Global Regulatory Lead, and cross functional colleagues within Alexion (i.e., commercial, research, clinical development, medical affairs, business development, legal, manufacturing, quality, portfolio management, financial, human resources, etc.).
Associate Director, Regulatory Affairs US Lead, Regulatory Science & Execution Alexion Pharmaceuticals IncAssociate Director, Regulatory Affairs US Lead, Regulatory Science & ExecutionGaithersburg, MD$135,624.80–$203,437.20 / yearThe Associate Regulatory Affairs Director, US Lead, Regulatory Science & Execution will be accountable for the development, implementation and maintenance of regulatory strategies for assigned project(s)/product(s) and regulatory jurisdiction(s), with the intention of achieving successful registration and lifecycle management of unique and technologically complex products serving patients with rare diseases and unmet medical needs. Providing strategic and tactical advice on regulatory issues for pipeline products; actively collaborates with management, Global Regulatory Lead, and cross functional colleagues within Alexion (i.e., commercial, research, clinical development, medical affairs, business development, legal, manufacturing, quality, portfolio management, financial, human resources, etc.).
Strategy and Operations Lead, Regulatory Affairs Google LLCStrategy and Operations Lead, Regulatory AffairsDCYou 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.
Senior Director Regulatory Affairs Liaison- General Medicine Merck & Co IncSenior Director Regulatory Affairs Liaison- General MedicineRockville, MD$190,800–$300,300 / yearRequired Skills: Corporate Commercial, Cross-Cultural Awareness, Drug Development, Exercises Judgment, Global Health, Global Market, Healthcare Innovation, Interpersonal Relationships, In Vitro Diagnostics (IVD), Multiple Therapeutic Areas, Oral Communications, Orphan Drugs, Pharmaceutical Regulatory Affairs, Process Improvements, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Communications, Regulatory Compliance, Regulatory Issues, Regulatory Management, Regulatory Strategy Development, Written Communication. As the Global Regulatory Lead (GRL), the Senior Principal Scientist functions as the regulatory single, accountable, global point of contact on the project team and interacts with the global regulatory agencies and/or subsidiaries with regard to global regulatory strategy/registration requirements for one or more company investigational and marketed drugs/biologics in early- and/or late-stage development.
NewDirector, Regulatory Affairs CTIADirector, Regulatory AffairsWashingtonJob title: Director, Regulatory AffairsDepartment: Regulatory Affairs Reports to: Senior Vice President, Regulatory AffairsSalary Range: $150,000 - $205,000 Summary:The Director, Regulatory Affairs works to advance the Regulatory Affairs Department’s mission of promoting the wireless industry’s positions on Federal regulatory policy issues on behalf of, and in coordination with, CTIA’s members. The Director works as part of the Regulatory Affairs team to monitor regulatory activity, coordinate calls and meetings, develop advocacy documents such as comments and letters, help the team prepare for panels and hearings, develop presentations, and provide other assistance as needed.
NewDirector, Regulatory Affairs Liaison, Vaccines & Infectious Diseases Merck & Co IncDirector, Regulatory Affairs Liaison, Vaccines & Infectious DiseasesRockville, MD$210,400–$331,100 / yearRequired Skills: Biological Sciences, Biostatistics, Clinical Judgment, Clinical Trial Planning, Clinical Trials, Communication, Cross-Functional Collaboration, Detail-Oriented, Infectious Disease, Leadership, Medical Writing, Pharmaceutical Regulatory Affairs, Pharmacovigilance, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Intelligence, Regulatory Issues, Regulatory Strategy Development, Regulatory Writing. Primary activities include, but are not limited to: Functions with a high degree of independence and provides regulatory oversight for assigned products, functioning as the single, accountable, global regulatory point of contact on those projects within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS.
Manager, Safety Regulatory Affairs and Certification Mitsubishi Motors North America, Inc.Manager, Safety Regulatory Affairs and CertificationDCRemoteWhile most day-to-day interactions will be conducted virtually, this position requires a proactive communicator who can effectively engage in a hybrid environment, balance independent remote work and occasional on-site presence with internal and external stakeholders to support team alignment and relationship-building. Job Summary: Lead the RAC-Safety team to ensure that all safety regulatory, certification and compliance matters affecting current and future vehicle content/design/development/performance are fully supported, and that items of importance to Mitsubishi Motors are reported on in a timely manner.
Principal Associate, Chief of Staff - Regulatory Affairs Capital One Financial CorpPrincipal Associate, Chief of Staff - Regulatory AffairsMcLean, VA$131,300–$149,800 / yearGEA teams include Regulatory Affairs, Risk, Innovation, Strategy and Enablement (RISE), Community Impact and Investment (CII), Community Finance, CRA Strategy and Program Management, Global Policy Affairs Group (GPAG), and Global Enterprise Communications (GEC). This associate will provide support to the Regulatory Affairs tower within GEA by executing, collaborating on and leading (as appropriate) substantive and significant projects and ongoing activities related to project delivery, team enablement and providing associates with a rewarding experience.
Regulatory Affairs Strategy Director AstraZeneca PlcRegulatory Affairs Strategy DirectorGaithersburg, MD$186,232.80–$279,349.20 / yearCompetitive 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. The more experienced you are, the more accountability you will have for strategic leadership including responsibility for development and implementation of the global regulatory strategy for a product/group of products of increasing complexity.
Vice President, Global Head of Regulatory Affairs Qiagen NVVice President, Global Head of Regulatory AffairsGermantown, MDCreate practical solutions to complex regulatory challenges by setting policies and procedures, aligning cross-functional teams, and maintaining strong working relationships with government and non-government organizations that affect market access and distribution. Strategic experience and ability, having demonstrated success related to the development and implementation of pre-clinical and clinical strategies for clinical IVD products, implementation of regulatory systems, and assuring compliance to all applicable regulations.
Director, Government & Regulatory Affairs (Hybrid - Washington D.C.,) BroadridgeDirector, Government & Regulatory Affairs (Hybrid - Washington D.C.,)District of ColumbiaReporting to the Head of Government Affairs, this individual will play a critical role in advancing Broadridge's policy priorities by building and maintaining relationships with key federal officials, monitoring legislative and regulatory developments, and positioning Broadridge as a trusted resource among policymakers and industry stakeholders. The ideal candidate brings deep knowledge of the financial services regulatory landscape, a strong network on Capitol Hill and within federal agencies, and the ability to translate complex regulatory issues into clear, compelling narratives for a variety of audiences.
Associate Regulatory Counsel, Privacy Google LLCAssociate Regulatory Counsel, PrivacyDCAs an Associate Regulatory Counsel in Privacy, you will join a Global team that provides subject matter expertise and engages with regulators and others to consider the role of privacy law in the changing economy, development of new technology, and passage of new laws and regulations. Preferred qualifications: 5 years of experience with legal, regulatory or corporate compliance in the field of privacy and data protection, including strategically addressing, minimizing and avoiding regulatory risk.
Manager, Regulatory Response Google LLCManager, Regulatory ResponseDCAs 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.
Senior Director, Head of US Regulatory Affairs Policy & Intelligence Teva Pharmaceutical Industries LtdSenior Director, Head of US Regulatory Affairs Policy & IntelligenceWashington, WA$248,000–$310,000 / yearAdditional benefits include, but are not limited to, Employee Assistance Program, Employee Stock Purchase Plan, Tuition Assistance, Flexible Spending Accounts, Health Savings Account, Life Style Spending Account, Volunteer Time Off, Paid Parental Leave, if eligible , Family Building Benefits, Virtual Physical Therapy, Accident, Critical Illness and Hospital Indemnity Insurances, Identity Theft Protection, Legal Plan, Voluntary Life Insurance and Long Term Disability and more. This role combines senior‑level regulatory policy leadership, regulatory intelligence, and external advocacy, with accountability for shaping US regulatory outcomes, enabling development and portfolio strategy, and strengthening Teva's influence and credibility with FDA and key stakeholders.
Manager, Regulatory Affairs - Advertising and Promotion Supernus Pharmaceuticals IncManager, Regulatory Affairs - Advertising and PromotionRockville, MD$100,000–$140,000 / yearp>Supernus Pharmaceuticals is an award-winning biopharmaceutical company with more than 30 years of experience in developing and commercializing products that treat central nervous system (CNS) diseases. The worker is required to have close visual acuity to perform an activity such as preparing and analyzing data and figures; transcribing; viewing a computer screen, iPad, or other electronic device; and extensive reading.
Director, Government & Regulatory Affairs (Hybrid - Washington D.C.,) Broadridge Financial Solutions IncDirector, Government & Regulatory Affairs (Hybrid - Washington D.C.,)DC$180,000–$190,000 / yearReporting to the Head of Government Affairs, this individual will play a critical role in advancing Broadridge's policy priorities by building and maintaining relationships with key federal officials, monitoring legislative and regulatory developments, and positioning Broadridge as a trusted resource among policymakers and industry stakeholders. The ideal candidate brings deep knowledge of the financial services regulatory landscape, a strong network on Capitol Hill and within federal agencies, and the ability to translate complex regulatory issues into clear, compelling narratives for a variety of audiences.
Regulatory Affairs Director AstraZeneca PlcRegulatory Affairs DirectorGaithersburg, MD$178,534–$267,801 / yearCompetitive 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. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles) or to receive a retirement contribution (hourly roles).
Executive Director, Regulatory Affairs Strategy - Cell and Gene Therapy AstraZeneca PlcExecutive Director, Regulatory Affairs Strategy - Cell and Gene TherapyGaithersburg, MD$276,127–$414,190 / yearMilestone Delivery and Dossier Excellence: Be accountable for delivery of all project-related regulatory milestones, including probability of regulatory success assessments, mitigation planning, approval strategy, lifecycle planning; lead preparation of regulatory strategy documents and target product labeling; ensure strong strategic planning and construction of the global dossier and core prescribing information; oversee maintenance and compliance for marketed brands where applicable. Accountabilities: Global Regulatory Strategy Leadership: Own the end-to-end global regulatory strategy for a cell and gene therapy product or franchise of exceptional complexity and strategic importance, from current stage through BLA submission, approval, and lifecycle management; may serve in a dual role as Franchise GRL and regional Regulatory Affairs Director.
Sr. Director/Director of Regulatory Affairs, Chemical & Environment KellenSr. Director/Director of Regulatory Affairs, Chemical & EnvironmentWashingtonInterested candidates should have a strong understanding of the chemical & environmental policy space regarding technical and regulatory processes as this individual will play a crucial role in representing client priorities and ensuring that client policies and positions are effectively communicated to government officials and other relevant stakeholders. The position is responsible for coordinating and delivering a wide range of member-driven initiatives across advocacy, technical programs, and industry engagement including the development of industry positions and proposals, participation in hearings, and engagement with regulators, stakeholders, and industry coalitions. .
Sr. Regulatory Affairs Analyst - Medical Devices Tunnell Government ServicesSr. Regulatory Affairs Analyst - Medical DevicesWashington, DCMinimum 15 years of device development; Government or industry experience in regulatory and/or quality affairs for diagnostic devices, particularly seeking expertise with imaging devices, software as a medical device, in vitro diagnostic devices, wearable technologies, digital health, and home use diagnostics. Duties of the position: This position will serve as regulatory affairs subject matter expert for multiple BARDA programs and projects involving development and manufacturing of in vitro diagnostic and device medical countermeasures specific to influenza, emerging infectious disease, CBRN threats (e.g.
Director Promotional Regulatory Affairs AstraZeneca PlcDirector Promotional Regulatory AffairsGaithersburg, MDDesirable Skills/Experience: • Advanced degree in life sciences, pharmacy, law, or a related discipline • 10 or more years of experience in US promotional regulatory affairs within biopharma, including direct OPDP/APLB interactions and resolution of advisory or enforcement matters • Experience leading or co-chairing MLR processes and operating within digital review systems such as AZAP or comparable platforms • Launch-to-lifecycle leadership across HCP and consumer promotions, managed markets materials, and omnichannel/digital campaigns • Proven ability to design and deliver effective regulatory training for commercial and medical stakeholders • Demonstrated influence at senior levels to shape departmental practices and operational plans • People leadership experience with a track record of coaching and building high-performing teams. Essential Skills/Experience: • Bachelor's degree in science • 3+ years' experience in promotional regulatory affairs, FDA (OPDP/APLB), or other equivalent experience in advertising and promotion review • 5+ years total experience in pharmaceutical/biotech industry, FDA, or equivalent experience • Strong knowledge of FDA promotional regulations and ability to apply such knowledge in review of diverse promotional materials and audiences • Knowledge of the drug development and labeling processes.
Program Manager, Regulatory Program Management Office Google LLCProgram Manager, Regulatory Program Management OfficeDCAs 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 OfficeDCAs 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.
Director of Regulatory Affairs,Tactical and Implementation Immunocore Holdings PlcDirector of Regulatory Affairs,Tactical and ImplementationGaithersburg, MD$157,500–$262,500 / yearp>Experience & knowledge Essential: • Solid track record in drug development and leadership within a dynamic project team • Emerging understanding of global regulatory requirements to be able to formulate tactical regulatory strategies • Ability to prepare and submit regulatory documentation to ensure regulatory compliance globally • Emerging ability to propose scientific regulatory strategies that are reviewed with line management for concurrence and approval • Excellent knowledge of US regulatory requirements and experience with submissions gained within drug development. The individual will also be assigned projects and regulatory activities by providing expertise to Immunocores development programs to include regulatory implementation of regulatory strategies, IND developments, submission, maintenance, tracking BLAs, BLA planning, submission, maintenance, tracking agency liaison for specific tactical assignments and regulatory intelligence for tactical process-related changes in requirements.
CMC REGULATORY AFFAIRS CONSULTANT (SENIOR-LEVEL) SciLucent LLCCMC REGULATORY AFFAIRS CONSULTANT (SENIOR-LEVEL)Herndon, VARemote$115,000–$215,000 / yearOur scientific/regulatory consulting team is expanding, and we are seeking a mid-level experienced scientific professional with a strong CMC Regulatory Affairs background to join our team of experienced professional consultants. We offer a congenial, supportive, and flexible work environment, the opportunity to work with knowledgeable consultants, and the ability to develop a tremendous amount of knowledge and expertise across many stages and areas of healthcare product development.
CLINICAL DEVELOPMENT & REGULATORY AFFAIRS ASSOCIATE (ENTRY LEVEL) SciLucent LLCCLINICAL DEVELOPMENT & REGULATORY AFFAIRS ASSOCIATE (ENTRY LEVEL)Herndon, VARemote$50,000–$80,000 / yearThe ideal candidate will have the following: • Bachelor's degree, in a relevant scientific discipline (e.g., biology, chemistry, biochemistry, clinical research, etc.) or equivalent relevant scientific/regulatory/quality experience, is required. We offer a congenial, supportive, and flexible work environment, the opportunity to work with knowledgeable consultants, and the ability to develop a tremendous amount of knowledge and expertise across many stages and areas of healthcare product development.
Vice President, Regulatory Affairs *PC 884 Miltenyi Biotec GmbHVice President, Regulatory Affairs *PC 884Gaithersburg, MD$295,600–$347,764 / yearp>Your Role: The role will be responsible to lead the regulatory strategy for US Biomedicine efforts in alignment with global efforts.?The role will oversee industry-specific practices, ensure all government and company regulations are being met, assessing regulatory risks and interfacing with regulatory authorities to ensure the company meets all set requirements and guidance's. Lead team members that provide regulatory affairs content and requirements for regulatory submissions and review this content for conformance with established requirement.?Manage and develop staff, if required, including staff professional development and project oversight accountability.?.
Senior Manager Regulatory Affairs US Advertising and Promotion - Immunology AbbVie IncSenior Manager Regulatory Affairs US Advertising and Promotion - ImmunologyDCApplicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.
Senior Director, Regulatory Affairs Strategy - Cell and Gene Therapy AstraZeneca PlcSenior Director, Regulatory Affairs Strategy - Cell and Gene TherapyGaithersburg, MD$218,058–$327,087 / yearAccountabilities: Global Regulatory Leadership: Own the end-to-end global regulatory strategy for a high-complexity cell and gene therapy program, from current stage through BLA submission, ensuring an efficient route to approval with competitive labeling aligned to product attributes and patient, market and business needs. Cross-Functional Product Leadership: Represent Regulatory Affairs on Global Product Teams, shaping development and commercialization plans, contributing to governance presentations and aligning regulatory objectives with clinical, CMC, safety and commercial strategies.
Regulatory Affairs Manager Katalyst Healthcares & Life SciencesRegulatory Affairs ManagerBaltimore, MDProvide leadership to Subject Matter Experts (SMEs) in multidisciplinary teams and manage day to-day operations of project tasks/activities to ensure deliverables are met in a timely manner within budget. Experience with multiple electronic software/platforms (such as Vantagepoint, Starting Point templates (or similar regulatory templates), Smartsheet, MS Office suite or other project management programs).
Associate Director Regulatory Affairs, Oncology GSK plcAssociate Director Regulatory Affairs, OncologyRockville, MD$138,750–$231,250 / yearThis role will ensure the development of appropriate global and/or regional regulatory strategy(s) and their execution for assigned asset(s) consistent with Medicines Development Strategy /Integrated Asset plan to ensure the development program meets the needs of the key markets identified and the Medicines Profile. Site Name: USA - Pennsylvania - Upper Providence, Durham Blackwell Street, USA - Maryland - Rockville, USA - Massachusetts - Waltham Posted Date: Jun 9 2026 Associate Director Regulatory Affairs, Oncology At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade.
NewSenior Regulatory Affairs Scientist VenescoSenior Regulatory Affairs ScientistFalls Church, VAJoin a dynamic regulatory team as a Senior Regulatory Affairs Scientist, where you will lead submission strategies and regulatory interactions for innovative medical products. QualificationsAdvanced degree in regulatory science, biology, or related field .
Senior Manager, Regulatory Affairs MEMASenior Manager, Regulatory AffairsWashingtonIn collaboration with the Vice President, Regulatory Affairs, the Senior Manager advances MEMA’s policy priorities, strengthens relationships with regulators and industry stakeholders, and helps ensure members are informed, engaged, and well positioned to navigate a fast-paced and evolving regulatory environment. The Senior Manager, Regulatory Affairs is an integral member of MEMA’s Government Affairs team and supports the association’s advocacy efforts by leading engagement on federal, state, and international regulatory issues affecting the motor vehicle supplier industry.
Executive Director, Regulatory Affairs JPMorgan Chase & CoExecutive Director, Regulatory AffairsDCOur history spans over 200 years and today we are a leader in investment banking, consumer and small business banking, commercial banking, financial transaction processing and asset management. JPMorgan Chase, one of the oldest financial institutions, offers innovative financial solutions to millions of consumers, small businesses and many of the world's most prominent corporate, institutional and government clients under the J.P.
Director, Regulatory Affairs - Neurology MedTech IQVIADirector, Regulatory Affairs - Neurology MedTechWashington, District of ColumbiaThe primary roles and responsibilities include managing the development of regulatory submissions, development of overall regulatory strategy, communicating with regulatory bodies and clients, and leading or expanding new therapy ideas, as applicable. Develop and execute regulatory services for client companies, including however not limited to: Regulatory Submissions (e.g., 510(k), IDE, PMA, IND, BLA, & IND, Technical Documentation, STED, CERs).
NewPolicy & Regulatory Affairs Manager Children's Hospital AssociationPolicy & Regulatory Affairs ManagerWashingtonThis position will manage significant health policy analysis for Children’s Hospital Association’s (CHA) advocacy work, including planning, organizing and providing policy analysis to influence the federal Administration on priority issues, and policy support for legislative advocacy, including the outlining of policy options and solutions to benefit children and children’s hospitals. Develop proactive advocacy strategies to advance CHA regulatory priorities in assigned issues; monitor, analyze, and respond to regulatory guidance and other administrative activities relevant to children’s hospitals and children’s health.
Executive Director, Regulatory Affairs Precigen IncExecutive Director, Regulatory AffairsGermantown, MDp>This role is responsible for defining regulatory strategy, planning and the preparation of US and eventually global regulatory submissions to achieve timely approvals of biologic licensing and marketing authorization applications and post-approval lifecycle changes for Precigen CAR-T and AdenoVerse immunotherapy Products. We are seeking a global Executive Director, Regulatory Affairs (level determined by candidate experience) reporting into the SVP Regulatory Affairs who is responsible for oversight of IND/IMPD, BLA and ex-US activities for the CAR-T and immunotherapy products.
Sr. Corporate Counsel - Federal Regulatory Affairs (Transactions and Competition) T-Mobile US IncSr. Corporate Counsel - Federal Regulatory Affairs (Transactions and Competition)washington, DC$144,100–$260,000 / yearWith the assistance of outside counsel, you'll be responsible for advocating for T-Mobile's transactions, including articulating the public interest benefits, managing filings, coordinating with internal and outside antitrust counsel, and, more broadly, advocating for competition policy that reflects the dynamic nature of the company's services. This position centers on effective advocacy: understanding T-Mobile's technology and services, combining data with deep knowledge of the law to create persuasive arguments, and clearly presenting the company's viewpoint while leveraging your knowledge of and relationships with key decision makers.