Traveling Community Manager (Affordable Housing) Pratum CompaniesTraveling Community Manager (Affordable Housing)Gaithersburg, MD$55,000–$75,000 / yearFull timeThis role is exempt and has an anticipated annual pay range of $55k-75k 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. Strong operational, compliance and regulatory understanding, including deep HUD Project Based Section 8 programs and Low-Income Housing Tax Credit (LIHTC) familiarity and knowledge.
Assistant Community Manager - Tax Credit & HUD Pratum CompaniesAssistant Community Manager - Tax Credit & HUDReston, VA$25–$29 / hourFull timeWe are seeking an experienced and results-driven Assistant Community Manager to oversee leasing operations at our affordable housing community governed by Low-Income Housing Tax Credit (LIHTC) and HUD Section 8 regulations. This role is non-exempt with a pay rate of $25-29 an 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.
Assistant Community Manager (Affordable Housing) Pratum CompaniesAssistant Community Manager (Affordable Housing)Falls Church, VAFull timeThis role is non-exempt and has an anticipated pay rate of $28.38 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. This position requires the ability to read and write English fluently, the ability to accurately perform intermediate mathematical functions and the ability to understand and perform all on-site resident management software functions.
Bilingual Community Manager - Tax Credit (Spanish/English) Pratum CompaniesBilingual Community Manager - Tax Credit (Spanish/English)Brentwood, MD$65,000–$70,000 / yearFull timeThis role is exempt and has an anticipated annualized base salary range of $65,000-$70,000 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. Collects rents and other monies due from residents; posts collections to resident account cards, prepares and makes bank deposits, prepares financial reports and reviews same to assure accuracy and completeness prior to submission.
Sr. Regulatory Manager, Regulatory Intelligence & Policy Thermo Fisher Scientific IncSr. Regulatory Manager, Regulatory Intelligence & PolicyWashington, DC$130,000–$194,950 / yearThe role partners with Business Q&RA, Government Relations, other Corporate functions and external information providers to enhance regulatory awareness, support enterprise alignment and provide regulatory intelligence that enables business-led implementation across Corporate Regulatory Affairs' remit. Working under the direction of the Senior Director, Corporate Regulatory Affairs, the role monitors the external regulatory environment, analyses regulatory and policy developments, and translates intelligence into actionable business insights to support informed decision-making.
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 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.
Regulatory Affairs Manager AstraZeneca PlcRegulatory Affairs ManagerGaithersburg, MD$109,244.80–$163,867.20 / yearSupport operational and compliance activities for assigned deliverables, including generating work requests and submission content plans, submission tracking, TMF, and document management utilizing the support and input of GRO, MCs, CROs and/or alliance partners where relevant. The RAM provides regulatory expertise and guidance on procedural and documentation requirements to GRET, GRST and cross-functional teams working flexibly within and across regions to ensure the delivery of business objectives.
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, Human Factors, Regulatory Affairs IQVIAManager, Human Factors, Regulatory AffairsWashington, District of ColumbiaDevelop and maintain usability engineering documentation, including use-related risk analyses, task analyses, user profiles, use specifications, and human factors engineering reports. Collaborate with cross-functional internal teams and manage external vendors to deliver complicated human factors study projects and regulatory submission projects.
Manager, Human Factors, Regulatory Affairs IQVIA Holdings IncManager, Human Factors, Regulatory AffairsWashington, DC$84,900–$212,200 / yearDevelop and maintain usability engineering documentation, including use-related risk analyses, task analyses, user profiles, use specifications, and human factors engineering reports. Collaborate with cross-functionalinternalteamsandmanageexternal vendorsto deliver complicatedhuman factors studyprojectsand regulatory submission projects.
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. WHS Regulatory Response Manager, Governance and External Affairs Amazon.com IncSr. WHS Regulatory Response Manager, Governance and External AffairsArlington, VARisk Manager in WHS Regulatory Response and Activity begins with reviewing overnight regulatory case management notifications of serious injury reports requiring 8-hour or 24-hour agency notification, previous day new inspection activity at sites across North America, and incoming correspondence from OSHA area offices or state plan agencies. The role demands the ability to leverage serious injury data and regulatory interaction trends to inform proactive risk mitigation strategies, brief VP+ leaders on emerging risks, translate complex enforcement actions into actionable guidance for site-level teams, and coach risk managers in building regulatory response capabilities.
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.
Program Manager, Regulatory Program Management Office Google LLCProgram Manager, Regulatory Program Management OfficeWashington D.C., DCAs 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.
Clinical Regulatory Writer, Associate Director / Manager AstraZeneca PlcClinical Regulatory Writer, Associate Director / ManagerGaithersburg, MD$133,042.40–$199,563.60 / yearOur team provides expert communications leadership to drug projects, authoring strategically important clinical-regulatory documents that align with project strategies and regulatory requirements. Essential Skills/Experience: Education/Experience required: Associate Director level: BS Life Sciences degree or simiilar, 7+ yrs medical writing experience in pharmaceutical industry or CRO.
NewSr Manager of Regulatory Compliance Constellation Energy Generation, LLC.Sr Manager of Regulatory ComplianceWashington, Washington, DCFull timeThis role also leads internal reviews and prepares responses to requests for information and inquiries from federal and state regulators, Independent System Operators/Regional Transmission Organizations (ISOs/RTOs), internal and external market monitors, and other regulatory and quasi-regulatory entities. Oversee internal investigations, reviews, and responses to compliance matters involving energy trading and ISO/RTO market participation, including regulatory inquiries and investigations from Independent Market Monitors, FERC, and other federal and state regulatory agencies.
Manager (Tax And Regulatory Compliance) National Education AssociationManager (Tax And Regulatory Compliance)Washington, DC$143,443–$203,775 / yearCandidates must have five to seven years of progressively responsible management experience in nonprofit or union accounting with extensive knowledge of Department of Labor LM-2 reporting, IRS Forms 990 and 990-T, partnership tax filings, District of Columbia tax requirements, sales and use tax, unclaimed property, ERISA Form 5500 reporting, GAAP (FASB ASC 958), and financial management. In addition to providing technical expertise, this leader supervises assigned staff, manages workflow priorities, develops training and guidance for stakeholders, supports financial system enhancements, prepares executive-level reporting and presentations, and partners with leadership to improve business processes and compliance across the organization.
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.
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.
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.
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.
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 Reporting Manager Deloitte Touche Tohmatsu LtdRegulatory Reporting ManagerMcLean, VA$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.
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.
Applied AI Manager Regulatory Covington & Burling LLPApplied AI Manager RegulatoryWashington, DC$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.
Business Development Manager (Regulatory or Transactional) Michael Page InternationalBusiness Development Manager (Regulatory or Transactional)Washington, District of Columbia$150,000–$200,000 / yearFull timeIdentifies 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 DescriptionImplements proactive, organized marketing and business development initiatives for select transactional practices, including client targeting programs and pursuit teams for target markets.
Litigation Marketing Senior Manager - Regulatory Cooley LLPLitigation Marketing Senior Manager - RegulatoryWashington DC, DC$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.
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.
Principal Product Compliance Manager - Money Transmission & Regulatory Compliance Intuit IncPrincipal Product Compliance Manager - Money Transmission & Regulatory ComplianceWashington D.C., DC$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.
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.
Strategy and Operations Lead, Regulatory Affairs Google LLCStrategy and Operations Lead, Regulatory AffairsWashington D.C., DC10 years of experience in management consulting, operations, business strategy, regulatory, legal or corporate advisory, or 8 years of experience with an advanced degree. Advise Regulatory Affairs leadership on critical OKRs, business plans, and operating plans while defining change management strategies to implement new initiatives.
["Regulatory Affairs Specialist | Public Comment Review Support","Regulatory Affairs Specialist | Public Comment Review Support"] ProSidian Consulting["Regulatory Affairs Specialist | Public Comment Review Support","Regulatory Affairs Specialist | Public Comment Review Support"]WashingtonProvide services and support as a Energy Technical Consulting (Regulatory Affairs Specialist) in the Energy, Science, and Technology Research Industry Sector focussing on Business Process Solutions for clients such as Department of Energy (DOE | OP) | DOE Office of Policy (OP) Generally Located In CONUS - Washington DC and across the Mid Atlantic Region (Of Country/World). Provide Public Comment Review, Data Analysis, Modeling, Evaluation, Mapping, Forecasting And Report Development, Data Tracking Tools, Workforce Policy Analysis And Convening, as well as Energy Market Economic And Regulatory Analysis Technical Consulting Services and support for The Department of Energy (DOE) Office of Policy (OP).
NewSr Manager of Regulatory Compliance Constellation Energy CorpSr Manager of Regulatory ComplianceWashington, DCBeginning May 7, 2025, candidates will need one of the following as identification in accordance of the Real ID ACT: Real ID, Passport, Visa, TWIC Card, to gain unescorted access. Cookies are used on this site to assist in continually improving the candidate experience and all the interaction data we store of our visitors is anonymous.
Senior Director, Regulatory Affairs (Ad Promo) Bausch Health Companies IncSenior Director, Regulatory Affairs (Ad Promo)Washington, DC$215,000–$296,000 / yearRepresents regulatory affairs in cross functional prescription product promotional review teams as required, participate in development committees for processes and procedures relating to ad promo. Job Location: Washington, District of Columbia, USA | Boston, Massachusetts, USA | Bridgewater, New Jersey, USA | NewYorkCity, New York, USA | Philadelphia, Pennsylvania, USA.
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.
Director, Government & Regulatory Affairs (Hybrid - Washington D.C.,) Broadridge Financial Solutions IncDirector, Government & Regulatory Affairs (Hybrid - Washington D.C.,)Washington, 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.
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.
Vice President, Global Head Of Regulatory Affairs Qiagen N.VVice President, Global Head Of Regulatory AffairsGermantown, MD$250,000–$300,000 / yearThe successful candidate will serve as the company's senior regulatory expert, partnering with executive leadership, regulatory agencies (FDA and global authorities), and cross-functional teams to ensure products achieve and maintain regulatory approval while supporting business growth and market access. Create 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.
General Attorney (Regulatory Affairs) U.S. Department of Homeland SecurityGeneral Attorney (Regulatory Affairs)Washington, DC$85,447–$197,200 / yearIf you are a current or former political Schedule A, Schedule C, Non-career SES or Presidential Appointee employee: Submit a copy of your applicable SF-50, along with a statement that provides the following information about your most recent political appointment: Position title, type of appointment (Schedule A, Schedule C, Non-career SES, or Presidential Appointee), agency and beginning and ending dates of appointment. RAU attorneys serve as regulatory counsel and play a significant role in the development and promulgation of regulatory actions relating to a variety of law enforcement authorities and functions, including immigration arrest, detention, and processing as well as oversight of the Student and Exchange Visitor Program.
Executive Director, Regulatory Affairs Precigen IncExecutive Director, Regulatory AffairsGermantown, MDThis 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.