NewTravel Nurse RN - Case Manager - $3,312 per week in Baltimore, MD TravelNurseSourceTravel Nurse RN - Case Manager - $3,312 per week in Baltimore, MDBaltimore, MD$3,312Job Title: Temp Manager Profession: Consultant-Clinical (non-bedside) Specialty: Case Management Duration: 12 Weeks Shift: Day 8 Hours per Shift: 8:30 AM - 5:00 PM Experience: Minimum 1 year of leadership experience License: RN licensure Certifications: ACM or CCM, CPR Must-Have: Deep understanding of Case Management and regulatory requirements Description: The Temp Manager will oversee the daily operations of the Case Management Department. The Temp Manager will be responsible for 18 full-time inpatient case managers and 5 prn weekend case managers.
Automotive Parts Manager Highline Passport Auto GroupAutomotive Parts Manager Highlinemarlow heights, MDFull timeWe are seeking an experienced Highline/Luxury Automotive Parts Manager to lead our parts department and support our service, sales, and wholesale operations. Qualifications 3–5+ years of automotive parts MANAGER experience; highline brand experience strongly preferred.
Manager, Regulatory Affairs - Advertising and Promotion Supernus Pharmaceuticals IncManager, Regulatory Affairs - Advertising and PromotionRockville, MD$100,000–$140,000 / yearSupernus 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.
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).
Scientific Program Manager (Regulatory Affairs) (51824) Gap Solutions, Inc.Scientific Program Manager (Regulatory Affairs) (51824)Bethesda, MDThese documents include, but are not limited to, clinical study protocols, informed consent documents, to ensure test plans encompass all required test elements, data parameters, test objectives, chemistry manufacturing and control (CMC) documents, and nonclinical study report summaries. Manage complex systems for data management and document control; supporting the dissemination of information on vaccine, monoclonal antibody, and other VRC clinical trials and collaborations using VRC products; and responds to related inquiries by sites, sponsors, FDA, and international regulatory agencies.
Manager, Regulatory Affairs - Advertising and Promotion Supernus PharmaceuticalsManager, Regulatory Affairs - Advertising and PromotionRockville, MarylandSupernus 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.
Senior Manager, Regulatory Affairs Getinge ABSenior Manager, Regulatory AffairsWashington D.C., DCRemoteThe Senior Manager, Regulatory Affairs, provides regulatory strategy and execution leadership for U.S., EU, and Rest of World (ROW) market access and compliance to enable safe, compliant market access for a broad Surgical Workflows Infection Control Consumable (SWICC) products portfolio, including a wide range of infection control consumables, while also supporting capital equipment such as sterilizers, washer-disinfectors, ultrasonic equipment, surgical lights, and operating tables. Serve as Regulatory Affairs authority in cross-functional product development teams, ensuring regulatory requirements are embedded in design controls, technical documentation, risk management (ISO 14971), labeling, and verification/validation planning, with accountability for U.S. (FDA), EU MDR, and applicable ROW regulatory decision-making.
Associate Manager - International Legislative and Regulatory Affairs Spotify Technology SAAssociate Manager - International Legislative and Regulatory AffairsWashington D.C., DC$107,448–$153,498 / yearThe Government Affairs team monitors, analyzes, and advocates on the legislative and regulatory issues that shape Spotify's business across the 180+ markets where our service is available. In this role, you'll help our global team understand these developments and contribute to thoughtful, coordinated policy strategies that support Spotify's business and users worldwide.
Associate Director/Senior Manager Regulatory Affairs Precigen IncAssociate Director/Senior Manager Regulatory AffairsGermantown, MDParticipation in project team and sub team discussions regarding preclinical, clinical and CMC aspects of drug development, providing regulatory guidance, communicating regulatory goals and timelines, and helping to ensure compliance to the requirements from U.S. and foreign regulatory agencies. The Associate Director/Senior Manager will interact with all aspects of Precigen's quality, CMC, preclinical, and clinical drug development programs, policies, and procedures ensuring compliance is maintained with all regulatory commitments/requirements.
Policy & Regulatory Affairs Manager Emerald AIPolicy & Regulatory Affairs ManagerWashington, District of ColumbiaThis role requires a high degree of ownership and judgment - you’ll be expected to operate independently, prioritize effectively in a fast-moving environment, and influence decisions across the organization. You’ll work closely with legal, product, operations, and leadership teams, as well as external stakeholders including regulators, policymakers, and industry groups.
Policy & 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.
Manager, Regulatory Counsel, Incidents Google LLCManager, Regulatory Counsel, IncidentsWashington D.C., DCYou will lead a high-performing team of tech-forward Program Manager (PgMs) and advise on how we leverage AI to scale our matter management and execution safely, ensuring that our shift toward automated, human-in-the-loop regulatory workflows is legally sound and defensible. Note: By applying to this position you will have an opportunity to share your preferred working location from the following: Mountain View, CA, USA; New York, NY, USA; San Francisco, CA, USA; Washington D.C., DC, USA.
Sr. Technical Program Manager, Regulatory, Amazon Leo Amazon.com IncSr. Technical Program Manager, Regulatory, Amazon LeoArlington, VAThe Regulatory Team obtains licenses for Amazon Leo services and earth stations in each country we will serve, advocates for rules and policies that benefit our customers, coordinates spectrum-use with satellite and terrestrial operators, files our constellation parameters with the International Telecommunication Union (ITU), and develops the data and analyses to support these activities. To enable Amazon Leo to achieve its mission, the Regulatory Team obtains licenses and approvals for space, services, ground-based infrastructure-such as the gateway stations that connect the Leo constellation to the internet and the user terminals that support customers-as well as the spectrum required to serve customers in each country where Leo will operate.
Senior Manager, Medical/Regulatory Writer Immunocore Holdings PlcSenior Manager, Medical/Regulatory WriterGaithersburg, MDVacancy NameSenior Manager, Medical/Regulatory Writer Vacancy NoVN831 Employment TypeFull Time Location of roleGaithersburg, MD, Radnor, PA, Remote, US DepartmentRegulatory Affairs Key ResponsibilitiesThe Senior Manager, Medical/Regulatory Writer will be accountable for leading and overseeing the medical and scientific regulatory writing for assigned programs to support submissions from first-in-human studies through product registration. Authoring or supervising the preparation of other regulatory documents required for Health Authority submissions, including but not limited to: Clinical Summaries (Clinical Overview, ISS/ISE, PK/PD summary, Advisory Committee Briefing document), Investigator Brochure(s), DSURs, other regulatory documents including briefing documents for health authorities, responses to Health Authority questions, etc.
Sr Manager Regulatory Submissions Philip Morris International U.S.Sr Manager Regulatory SubmissionsWashington, DCFull timeThe role entails leading the planning, authorship, and editorial quality of high‑stakes regulatory documents to support U.S. tobacco/nicotine product submissions and lifecycle obligations, ensuring clear, accurate, and compliant communication with the FDA and other external stakeholders. Since 2008, PMI has invested $12.5 billion globally to develop, scientifically substantiate and commercialize innovative smoke-free products for adults who would otherwise continue to smoke with the goal of transitioning legal-age consumers who smoke to better alternatives.
Manager, US Regulatory Submissions Philip Morris International U.S.Manager, US Regulatory SubmissionsWashington, DCFull timeThe role entails helping drive the planning, authorship, and editorial quality of high‑stakes regulatory documents to support U.S. tobacco/nicotine product submissions and lifecycle obligations, ensuring clear, accurate, and compliant communication with the FDA and other external stakeholders. Since 2008, PMI has invested $12.5 billion globally to develop, scientifically substantiate and commercialize innovative smoke-free products for adults who would otherwise continue to smoke with the goal of transitioning legal-age consumers who smoke to better alternatives.
Senior CMC Regulatory Strategy Manager GSK plcSenior CMC Regulatory Strategy ManagerRockville, MD$144,375–$240,625 / yearGSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients' needs and have the highest probability of success. Directs and communicates complex regulatory issues independently across the company and with external agencies and third parties as necessary, to influence project and policy issues that are aligned with business needs ensuring optimum position for the company.
Manager, State Regulatory & Production Policy (South) Netflix IncManager, State Regulatory & Production Policy (South)Washington, DC$240,000–$370,000 / yearThis role is dedicated to U.S. State Regulatory and Production Policy, focusing on the Southern Region (Texas to the DC-Maryland-Virginia area) within the UCAN Global Affairs team, and reports to the Head of U.S. State Regulatory Policy based in Los Angeles. As part of this team, the successful candidate will lead Netflix's legislative and regulatory efforts across the Southern region, working with policymakers, industry groups, and third-party advocates to promote sound regulatory practices.
Regulatory and Litigation Senior Counsel and Manager, Content and Society Google LLCRegulatory and Litigation Senior Counsel and Manager, Content and SocietyWashington D.C., DCPartner closely with team leads in Privacy, Consumer Protection and User Safety, Global Legislative Oversight, Law Enforcement and Security, Competition, Investigations and Incidents, EMEA and APAC Investigations and Enforcement teams, Advisory and Engagement, and the Regulatory Response teams to drive efficient, and effective regulatory defense for the Company. Defend content audits, assess the need for, and file, affirmative issues to laws pertaining to content issues that we believe to be legally defective or bad for users, and manage global coordination of content regulatory matters that span regions.
NewSenior Business Development Manager - Cyber & Data Privacy Regulatory OrrickSenior Business Development Manager - Cyber & Data Privacy RegulatoryWashington, DC$147,000–$220,000 / yearThe objective: As a Senior Business Development Manager for our Strategic Advisory & Government Enforcement (Sage) business unit, you will serve as a strategic thought partner to practice leaders and partners, shaping go-to-market strategy, identifying whitespace opportunities, and translating market intelligence into actionable growth plans. The Senior Business Development Manager will provide marketing and business development expertise for our Cyber, Privacy & Data Innovation team and other practice groups in the Sage business unit, which cover International Trade, Financial Services & Fintech Advisory, White Collar, Public Policy, and Technology Transactions.
Senior Manager, Regulatory Practices - Enterprise Services Risk Capital One Financial CorpSenior Manager, Regulatory Practices - Enterprise Services RiskMcLean, VA$200,700–$229,100 / yearYou will provide proactive and on-going regulatory intelligence to our Enterprise Services divisions to ensure they remain well-managed, including autonomous coordination and drafting of internal communications and briefs for regulator meetings, attending meetings with regulators, drafting meeting notes, updating regulators on recent developments, updating reporting and ensuring completion of any follow up actions after the meetings. You will partner across Enterprise Services (ES) to develop and support successful, forward-thinking Regulatory engagements and reporting in a manner that supports innovation, protects our customers, shareholders, and associates, and considers themes, opportunity patterns and scale across the function and enterprise.
Sr Manager, Regulatory Advisory Compliance T. Rowe PriceSr Manager, Regulatory Advisory ComplianceOwings Mills, MarylandSuccess in this role requires deep expertise in compliance and registration disciplines, exceptional communication skills, demonstrated experience with handling multiple tasks at the same time, strong attention to detail, self-motivation, and the ability to influence management and key external stakeholders on broad-ranging initiatives. As a premier global asset management organization with more than 85 years of experience, we provide investment solutions and a broad range of equity, fixed income, and multi-asset capabilities to individuals, advisors, institutions, and retirement plan sponsors.
Regulatory Reporting Manager Deloitte Touche Tohmatsu LtdRegulatory Reporting ManagerVA$82,600–$162,800 / yearManage end to end regulatory reporting activities covering 40 Act and non-40 Act funds in the investment management space (e.g., Form PF, TIC, CPO-PQR, Form 16, Form 13, N-PX, BEA reports), ensuring compliance with applicable regulatory requirements across various regulators such as SEC, CFTC, BEA, NFA, Treasury. We "embed continuous advantage" through domain, industry, technology and transformation skills to perform client business functions that manage risk and deliver value-added outcomes, all while driving predictable long-term revenue, profitability, and growth.
Regulatory Compliance Manager, Operational Improvement RangeRegulatory Compliance Manager, Operational ImprovementMcLean, VirginiaAs Regulatory Compliance Manager, Operational Improvement , you’ll be responsible for building and maintaining the operational compliance cadence that supports Range’s growth, evolving regulatory requirements, and broker-dealer supervision needs. Execute and continuously improve supervision and surveillance processes, including trade and account reviews, Reg BI and Form CRS governance support, OBAs, gifts and entertainment monitoring, and insider trading surveillance.
Regulatory Compliance Manager, GTM Enablement RangeRegulatory Compliance Manager, GTM EnablementMcLean, VirginiaServe as the subject matter expert for advertising and client communications compliance, translating regulatory rules into clear guidance, templates, and training for partner teams. Support Range’s expansion into video and long-form content—such as market insights, webinars, and video advertising — by providing timely, clear, and scalable compliance reviews.
Senior Manager, Cyber Audit and Regulatory Engagements Capital One Financial CorpSenior Manager, Cyber Audit and Regulatory EngagementsMcLean, VA$200,700–$229,100 / yearCandidates hired to work in other locations will be subject to the pay range associated with that location, and the actual annualized salary amount offered to any candidate at the time of hire will be reflected solely in the candidate's offer letter. As a Senior Manager of Cyber Audits and Exams at Capital One, you will work closely across the Cybersecurity organization to coordinate and execute on audit, regulatory and executive engagements.
Manager, Cyber Audit and Regulatory Engagements Capital One Financial CorpManager, Cyber Audit and Regulatory EngagementsMcLean, VA$164,800–$188,100 / yearCandidates hired to work in other locations will be subject to the pay range associated with that location, and the actual annualized salary amount offered to any candidate at the time of hire will be reflected solely in the candidate's offer letter. As a Manager of Cyber Audits and Exams at Capital One, you will work closely across the Cybersecurity organization to coordinate and execute on audit, regulatory and executive engagements.
Applied AI Manager Regulatory Covington & Burling LLPApplied AI Manager RegulatoryDC$153,000–$228,000 / yearView Covington job applicant privacy notice here httpswww.cov.comenjob-applicant-privacy -notice access pursuant to US Export Control laws candidate must be either a a United States citizen or national b a person lawfully admitted for permanent residence of the United States i.e. Green Card" holder or c an INS-approved refugee or asylum holder who has applied for naturalization within six months of the date the individual first became eligible and if not yet naturalized is still actively pursuing naturalization if 2 years have passed since the date of application to be granted access pur suant to US Export Control laws. regulatory research horizon scanning advisory memos agency filings compliance support sufficient to translate attorney requirements into AI solutions familiarity Duties and Responsibilities Design build and maintain AI-enabled workflows and automation for regulatory analysis filings monitoring and advisory work including regulatory horizon scanning regulatory research advisory memo drafting support agency filing and submission workflows and compliance monitoring.
Senior Regulatory Strategist and Safety Manager Airbus SESenior Regulatory Strategist and Safety ManagerHerndon, VAJob Description: Airbus requires regulatory and safety expertise in order to establish the competence & authority enabling it to ensure Airbus processes comply with regulatory and safety requirements of the Aviation Authorities (including NAA's) in order to support our Operators. This role will also apply the intelligence cycle (planning & direction, collection, analysis, dissemination) to recognize threats and opportunities, anticipate trends or developments that might have a direct impact on the company.
Litigation Marketing Senior Manager - Regulatory Cooley LLPLitigation Marketing Senior Manager - RegulatoryReston, VA$170,000–$240,000 / yearSpecific duties and responsibilities include, but are not limited to, the following: Position responsibilities: Strategic planning and leadership: In conjunction with the Associate Director or Director of Marketing (Business/Litigation), department and practice group leaders, develop and execute marketing and business development plans for assigned practice group(s)/industries/verticals, and individual partners within those groups. In this leadership role, the Senior Practice Group Marketing Manager will interact with practice group leaders and partners in devising marketing and client development programs in a manner consistent with the firm's overall strategy.
NewManager, Business Development (Regulatory) Skadden Arps Slate Meagher and Flom LLPManager, Business Development (Regulatory)Washington, DC$170,000–$185,000 / yearWorks closely with the Senior Manager of Business Development (Tax), the Director of Business Development (Regulatory), practice leaders, relevant attorneys and various members of the Business Development & Marketing (BDM) Department to strengthen existing client relationships and secure new client engagements in alignment with overall practice business development goals. This role leads key business development initiatives and strategies, including driving new business development, existing client growth, inbound and outbound cross-selling, and delivering high-level proposals, RFPs, and other business development and marketing materials.
Manager, Government Relations and Regulatory Strategy London Stock Exchange Group PlcManager, Government Relations and Regulatory StrategyWashington, DC$110,400–$184,000 / yearWe partner with business divisions and functions as well as with our colleagues in the Corporate Affairs & Marketing Division to position LSEG as a trusted resource and thought leader with key decision-makers on policy issues impacting the future of our industry. Although this role is focused on US engagement, as part of the global government relations team, you will work with a diverse, global and distributed team, that works across geographies, business areas, and functions to drive campaigns that support key priorities for LSEG globally.
Manager, Business Development (Regulatory) SkaddenManager, Business Development (Regulatory)WashingtonWorks closely with the Senior Manager of Business Development (Tax), the Director of Business Development (Regulatory), practice leaders, relevant attorneys and various members of the Business Development & Marketing (BDM) Department to strengthen existing client relationships and secure new client engagements in alignment with overall practice business development goals. This role leads key business development initiatives and strategies, including driving new business development, existing client growth, inbound and outbound cross-selling, and delivering high-level proposals, RFPs, and other business development and marketing materials.
Procurement Regulatory Compliance Manager Johns Hopkins Applied Physics LaboratoryProcurement Regulatory Compliance ManagerLaurel, MarylandFull timeAs part of the Procurement Compliance Section support both internally and externally conducted audits including reviewing procurement purchase order and subcontract documentation, responding to auditor questions, and addressing any post-audit actions. As a Procurement Compliance Manager your primary responsibility will be to proactively assess the impact of changing regulations in the Federal Acquisition Regulation and Defense Federal Acquisition Regulation relating to Procurement, new Executive Orders, and other related government audit trends.
NewBusiness Development Manager (Regulatory or Transactional) Michael Page InternationalBusiness Development Manager (Regulatory or Transactional)Washington, DC$150,000–$200,000 / yearIdentifies and supports cross-practice and cross-region opportunities, collaborating with attorneys and marketing to align strategies, measure target progress, and leverage those opportunities to drive overall business development plans. Job Description Implements proactive, organized marketing and business development initiatives for select transactional practices, including client targeting programs and pursuit teams for target markets.
Principal Product Compliance Manager - Money Transmission & Regulatory Compliance Intuit IncPrincipal Product Compliance Manager - Money Transmission & Regulatory ComplianceDC$207,500–$281,000 / yearThis person will operate as a senior compliance expert and collaborative cross-functional partner, exercising broad influence across product, engineering, legal, and business functions, while serving as a key participant in regulatory examinations and driving proactive exam readiness. Broad working knowledge of adjacent regulatory domains - including AML/BSA, OFAC/sanctions compliance, financial reporting obligations, and bank partnership risk - sufficient to navigate, advise, and identify cross-domain risk without dependency on dedicated program owners.
Regulatory Compliance Manager US Antiboycott Citigroup IncRegulatory Compliance Manager US AntiboycottDC$167,920–$251,880 / yearServes as a product compliance risk officer within Services Independent Compliance Risk Management (ICRM) organization with primary focus on US Antiboycott compliance and responsible for establishing internal strategies, policies, procedures, processes, and programs to prevent violations of law, rule, or regulation and design and deliver a risk management framework that maintains risk levels within the firm's risk appetite and protect the franchise. Appropriately assess risk when business decisions are made, demonstrating particular consideration for the firm's reputation and safeguarding Citigroup, its clients and assets, by driving compliance with applicable laws, rules and regulations, adhering to Policy, applying sound ethical judgment regarding personal behavior, conduct and business practices, and escalating, managing and reporting control issues with transparency.
NewBusiness Development Manager (Regulatory or Transactional) Michael PageBusiness Development Manager (Regulatory or Transactional)Washington, DC$150,000–$200,000 / yearIdentifies and supports cross-practice and cross-region opportunities, collaborating with attorneys and marketing to align strategies, measure target progress, and leverage those opportunities to drive overall business development plans. Implements proactive, organized marketing and business development initiatives for select transactional practices, including client targeting programs and pursuit teams for target markets.
Food Safety Program Manager - Regulatory Support Chewy IncFood Safety Program Manager - Regulatory SupportJessup, MDWhat You'll Need: BS in Chemistry, Biology, Food Safety, Food Science, Environmental; Engineering; or related technical field is; required; Advanced MS in Chemistry, Biology, Food Safety, Food Science, Environmental; Engineering; or related technical field is preferred; Minimum of 2+ years in Food Safety and Quality Control in a distribution, warehousing, and/or manufacturing setting. The Regional Food Safety Specialist will; be responsible for; partnering with the Site Operations team, Continuous Improvement, Learning, Quality, and Facility teams to manage the deliverables; required; at the FC network.
Director, 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.
NewPrincipal 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.
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.
NewSenior Regulatory Affairs Director AstraZeneca PlcSenior Regulatory Affairs DirectorGaithersburg, MD$218,058.40–$327,087.60 / yearOptional: May be accountable for leadership of regulatory operational activities from planning to submission of regulatory applications and HA interactions, providing regulatory expertise and advice on procedural and documentation requirements to product teams and execution submission delivery plans across all regions. Lead the planning and construction of the global dossier and core prescribing information, conduct regulatory risk planning and mitigation, and lead the Global Regulatory Sub-team (GRST) with key contributing members from a regional perspective, emerging markets, RA CMC as well as delivery & enablement.
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.
Vice President, MedTech Cardiovascular Regulatory Affairs IQVIAVice President, MedTech Cardiovascular Regulatory AffairsWashington, District of ColumbiaThe Vice President, MedTech Cardiovascular Regulatory Affairs will be a critical team member and Company leader supporting regulatory strategy and submissions for the firm’s clientele, and managing and leading their domain specific department, as required. 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) Regulatory Strategy, Analysis & Development.
Regulatory Scientific Reviewer (Regulatory Specialist) US Department of Health and Human ServicesRegulatory Scientific Reviewer (Regulatory Specialist)Rockville, MD$102,415–$138,182 / yearThe Food and Drug Administration is the regulatory, scientific, public health, and consumer protection agency responsible for ensuring that all human and animal drugs, and medical devices are safe and effective, that cosmetics, foods, food additives, drugs and medicated feeds for food producing animals, and radiation emitting devices are safe, and that all such products marketed in the United States are adequately, truthfully and informatively labeled and safely and properly stored, transported, manufactured packaged and regulated. Basic Qualification Requirements: A bachelors or graduate/higher level degree in quality assurance or a related degree in one or a combination of the following: consumer laws, biological sciences, food science, chemistry, pharmacy, physical sciences, food technology, nutrition, medical science, engineering, epidemiology, veterinary medical science, legal investigations, law enforcement, or related scientific fields that provided knowledge directly related to consumer product reviewer work.
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.
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).
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).
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.