NewCoding Specialist III - Plastics/Podiatric Surgery MedStar HealthCoding Specialist III - Plastics/Podiatric SurgeryMDRemote$28.76–$48.96Handles complex coding case review including but not limited to surgical coding (Orthopaedics Cardiac Neurosurgery Otolaryngology etc.) extraction, co-surgery scenarios, multi-visceral transplant cases, comorbidity evaluation. In addition to interacting with physicians on coding issues, ensures that physician encounter forms, the GE IDX billing system and processes are up to date and compliant regarding coding issues.
eDiscovery Application Support Specialist NuAxis InnovationseDiscovery Application Support SpecialistWashington DC, DCThis position is responsible for maintaining secure and highly available eDiscovery environments, troubleshooting complex application and infrastructure issues, supporting legal hold and compliance initiatives, and partnering with investigative, legal, cybersecurity, and IT stakeholders to ensure operational excellence and data integrity. The ideal candidate will possess extensive experience administering and supporting Relativity and other litigation support platforms, while providing infrastructure, application, and investigative workflow support across the Electronic Discovery Reference Model (EDRM) lifecycle.
NewPilot Training & Qualification Specialist Air Line Pilots AssociationPilot Training & Qualification SpecialistTysons (McLean), VARemote$97,948–$139,923 / yearEmployees do not have to pay premiums if they enroll in the Aetna High Deductible Health Plan or the Kaiser HMO Plan; days paid vacation and holidays per year plus 2 volunteer days per year; Generous sick and bereavement leave; Competitive parental leave; Company-paid coverage for long term disability, life insurance, and accidental death & dismemberment; Flexible Spending and Health Savings accounts; Retiree health plan and a retiree health account (retiree HRA). The Air Line Pilots Association, International (ALPA), the largest airline pilot union in the world and the largest non-governmental aviation safety organization in the world (representing over 80,000 pilots at 42 U.S. and Canadian airlines) seeks an experiencedPilot Training & Qualification Specialist for our Tysons (McLean), Virginia office.
Sr. Application Specialist Keller North America, Inc.Sr. Application SpecialistHanover, MD$84,000–$107,000 / yearThis role serves as a subject matter expert and liaison between HR, IT, and business stakeholders to ensure HR systems meet organizational needs and support strategic initiatives. By connecting global resources and local experience, Keller develops innovative, practical, and cost-effective solutions to geotechnical challenges.
Sr. Application Specialist 1BritcomSr. Application SpecialistHanover, MD$84,000–$107,000 / yearThis role serves as a subject matter expert and liaison between HR, IT, and business stakeholders to ensure HR systems meet organizational needs and support strategic initiatives. By connecting global resources and local experience, Keller develops innovative, practical, and cost-effective solutions to geotechnical challenges.
NewField Growth & Customer Experience Marketing Specialist AramarkField Growth & Customer Experience Marketing SpecialistJessup, MD$55,000–$67,000They will be responsible for management and implementation of Aramark Refreshments? marketing objectives and activities including local store marketing initiatives, regional marketing programs, client activations, product and equipment marketing, and product management and analysis. Develop social content that promotes regional activities, experiences, innovations, new openings as well as spotlights employees to support the social media team?s overall marketing/communication strategy.
NewNurse Professional Development Specialist ( Cardiovascular ICU ) - Relocation Offered! MedStar HealthNurse Professional Development Specialist ( Cardiovascular ICU ) - Relocation Offered!Baltimore, MD$42.82–$71.16Demonstrates clinical expertise leadership communication skills and knowledge of education theory and principles necessary to develop learning programs and achieve optimal educational outcomes. CPR - Cardiac Pulmonary Resuscitation (includes BLS and NRP) for healthcare providers from either the American Heart Association (AHA) or American Red Cros within 90 Days required.
NewAssociate Corporate Counsel, Amazon Leo (Satellites) Amazon.com Services LLCAssociate Corporate Counsel, Amazon Leo (Satellites)Arlington, VAYour day might include analyzing emerging regulatory frameworks for low Earth orbit networks, collaborating with our technical teams to understand system architecture and identify legal implications, or advising business stakeholders on strategic decisions involving spectrum licensing or international telecommunications agreements. As an Associate Corporate Counsel supporting Amazon Leo, you'll engage with novel legal questions that span satellite technology, regulatory licensing matters, and international operations across Latin America.
Document Control Specialist - 28449 Company ConfidentialDocument Control Specialist - 28449Arlington, VA$54,502–$80,000Full timeOur capabilities in cybersecurity, network architecture, reverse engineering, software and hardware development uniquely enable us to support sensitive missions for the U.S. military and federal agency partners. Our capabilities range from C5ISR, AI and Big Data, cyber operations and synthetic training environments to fleet sustainment, environmental remediation and the largest family of unmanned underwater vehicles in every class.
Compliance Specialist (C&L - Affordable Housing) Pratum CompaniesCompliance Specialist (C&L - Affordable Housing)Gaithersburg, MDRemote$60,000–$70,000 / yearFull timeYour duties will include completing various projects to support the on-site compliance of properties including the leasing, recertifications, auditing and third-party audit support requiring effective communication with our clients, building effective relationships and transmitting information to coworkers and managers using multiple platforms. This role is non-exempt and has an anticipated pay range of $60k-$70k annualized for a new employee depending on a number of relevant factors including individuals’ experience, qualifications, knowledge, skills, abilities, client/property or company budgetary limitations/guidelines, and other job-related company and market considerations.
Traveling Compliance Specialist (C&L - Affordable Housing Programs) Pratum CompaniesTraveling Compliance Specialist (C&L - Affordable Housing Programs)Gaithersburg, MDRemote$25–$30 / hourFull timeThis role is non-exempt and has an anticipated hourly pay range of $25.00-$30.00/hour for a new employee depending on a number of relevant factors including individuals’ experience, qualifications, knowledge, skills, abilities, client/property or company budgetary limitations/guidelines, and other job-related company and market considerations. Must have a minimum three (3) years recertification experience with a preference for professional certification(s) such as Certified Occupancy Specialist (COS), Tax Credit Specialist (TCS), or any of the industry HUD and LIHTC designations required- Section 8 or Public Housing is acceptable.
Traveling Recertification Specialist (C&L - Affordable Housing Compliance) Pratum CompaniesTraveling Recertification Specialist (C&L - Affordable Housing Compliance)Gaithersburg, MDRemote$22–$26 / hourFull timeAlthough the Washington DC Metropolitan area, including Virginia and Maryland are primarily be where support is needed, such that reliable transportation for regional travel is a requirement, - This role will require travel nationwide to support third party management clients, as well as supporting Pratum's portfolio within the Washington DC Metropolitan area, including Virginia and Maryland are primarily be where support is needed, such that reliable transportation for regional travel is a requirement, overnight and multi-day travel to any state for operational coverage is a requirement of the role. This role is non-exempt and has an anticipated hourly pay range of $22-$26/hour (~$45k-54k annually) for a new employee depending on a number of relevant factors including individuals’ experience, qualifications, knowledge, skills, abilities, client/property or company budgetary limitations/guidelines, and other job-related company and market considerations.
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.
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 & 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.
NewRegulatory Affairs Specialist (North America, LATAM, EU) AlimentivRegulatory Affairs Specialist (North America, LATAM, EU)Baltimore, MarylandRepresent the unit at project meetings, assisting with project education/regulatory tool development, at regulatory reviews and audits, with clients ensuring expectations are managed and met, with regulatory, ethics and government representatives and, when appropriate, respond to regulatory queries on behalf of the client. Conduct or assist with regulatory and/or safety reviews, create regulatory-related tools, educational/training materials, and remain current on all aspects of clinical research regulatory requirements and industry best practices, communicating changes to project leaders in a timely manner.
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.
Financial Regulatory Specialist DLA Piper LLP (US)Financial Regulatory SpecialistDC$88,383–$117,111 / yearWhile 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.
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.
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 SpecialistLaurel, MDThis 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.
Regulatory Reporting Specialist, Responsible Minerals and Human Rights Compliance Google LLCRegulatory Reporting Specialist, Responsible Minerals and Human Rights ComplianceWashington D.C., DCAs the Responsible Minerals and Human Rights Compliance Regulatory Reporting Specialist, you will play a critical role in advancing our Responsible Minerals Program strategy, executing key initiatives across Alphabet and Google, and managing conflict minerals, anti-modern slavery, and human rights compliance and regulatory reporting obligations. Partner with product area and functional teams to prioritize requirements, influence strategic roadmaps, and ensure responsible minerals and human rights regulatory requirements are integrated into business operations.
Financial Crime Risk Specialist - Regulatory Response & Audit Oversight The Toronto-Dominion BankFinancial Crime Risk Specialist - Regulatory Response & Audit OversightVienna, VA$91,000–$145,600 / yearTotal Rewards at TD includes base salary and variable compensation/incentive awards (e.g., eligibility for cash and/or equity incentive awards, generally through participation in an incentive plan) and several other key plans such as health and well-being benefits, savings and retirement programs, paid time off (including Vacation PTO, Flex PTO, and Holiday PTO), banking benefits and discounts, career development, and reward and recognition. Employee/Team Accountabilities: Participates fully as a member of the team, supports a positive work environment that promotes service to the business, quality, innovation and teamwork and ensure timely communication of issues / points of interest.
Sr. Regulatory Compliance Specialist, Amazon Leo Security Assurance Amazon.com IncSr. Regulatory Compliance Specialist, Amazon Leo Security AssuranceArlington, VABuild and maintain a global regulatory compliance program covering NIS2, DORA, the Security of Critical Infrastructure Act 2018 (SOCI), the EU Cyber Resilience Act (CRA), and other applicable regulations - including identifying requirements, assessing gaps, developing remediation strategies, and driving remediation activities to completion. In this role, you will work collaboratively with various business and security teams across Amazon to identify compliance needs, assess the maturity of processes and controls, design, build, and execute high-impact security or compliance programs and liaise with external auditors and regulators.
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.
Regulatory Compliance Specialist 3 Oracle CorpRegulatory Compliance Specialist 3Arlington, VA$70,600–$141,200 / yearOracle maintains broad salary ranges for its roles in order to account for variations in knowledge, skills, experience, market conditions and locations, as well as reflect Oracle''s differing products, industries and lines of business. You will collaborate with cross-functional teams-both internal stakeholders and client partners-so familiarity with risk management frameworks, program management best practices and business process re-engineering is essential.
NewRecent Graduate - Regulatory Specialist U.S. Department of LaborRecent Graduate - Regulatory SpecialistWashington, DC$70,623–$111,087 / yearApplicants meeting the eligibility and minimum qualification requirements will be evaluated against the competencies described below and will be placed into one of the following quality categories, based on responses to the vacancy questionnaire: Category A - Meets the basic qualification requirements for the vacancy and has successful experience in the same or similar job that has demonstrated superior proficiency in applying the critical competencies required by this position to work of increased levels of difficulty and complexity. Was released or discharged from active duty within the previous two years, where the applicant is a veteran who, due to a military service obligation, was precluded from applying for a recent graduate position during any portion of the two-year eligibility period following completion of his/her degree or certificate requirements, provided that not more than six years have transpired since the applicant completed the requirements for a degree or certification.
NewRegulatory Specialist U.S. Department of LaborRegulatory SpecialistWashington, DC$70,623–$133,142 / yearSpecial/Non-Competitive Appointing Authority Documents - Applicants who are eligible for consideration, and wish to be considered, under one of the following non-competitive hiring authorities must submit appropriate documentation (click on the links below to see the documentation requirements): (a) Military Spouses (MISP) (b) Other. Responsible for reviewing and analyzing comments received on proposed occupational health and safety regulations and determining, in conjunction with technical program personnel, management, and the Office of the Solicitor, whether the issues raised in written comments have sufficient merit to warrant changes in the proposed regulation.
NewSenior Specialist, Business Development (Regulatory) SkaddenSenior Specialist, Business Development (Regulatory)WashingtonSupports the Regulatory BD leadership team with the identification of new targets and the execution of various activities that enable partners to build new relationships through the coordination of target management, meetings and events, pitches, and proposals, and thought leadership promotion. Facilitates seamless coordination of business development initiatives by developing and executing on business development goals and liaising with essential teams, including Marketing, Communications, Firm Recognition, Proposals, Content, Events, Experience, and Strategic Intelligence.
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.).
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.
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.
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 OnePrincipal Associate, Chief of Staff - Regulatory AffairsMcLean, VirginiaGEA 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.
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.
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.
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.
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.
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 of Regulatory Affairs,Tactical and Implementation Immunocore Holdings PlcDirector of Regulatory Affairs,Tactical and ImplementationGaithersburg, MD$157,500–$262,500 / yearExperience & 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.
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 .
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.