NewProject Manager (Commercial Landscaping) JobotProject Manager (Commercial Landscaping)Ashton, MD$130,000–$190,000 / yearInformation collected and processed as part of your Jobot candidate profile, and any job applications, resumes, or other information you choose to submit is subject to Jobot's Privacy Policy, as well as the Jobot California Worker Privacy Notice and Jobot Notice Regarding Automated Employment Decision Tools which are available at jobot.com/legal. The successful candidate will be responsible for managing and growing the company's financials, overseeing operations, and reporting directly to the president.
NewPermits Manager for Region, DC Design Engineering Amazon Data Services, Inc.Permits Manager for Region, DC Design EngineeringHerndon, VAYou’ll join a diverse team of software, hardware, and network engineers, supply chain specialists, security experts, operations managers, and other vital roles. We pioneered cloud computing and never stopped innovating — that’s why customers from the most successful startups to Global 500 companies trust our robust suite of products and services to power their businesses.
NewTax Manager (mostly Remote) JobotTax Manager (mostly Remote)Hanover, PARemote$115,000–$160,000 / yearInformation collected and processed as part of your Jobot candidate profile, and any job applications, resumes, or other information you choose to submit is subject to Jobot's Privacy Policy, as well as the Jobot California Worker Privacy Notice and Jobot Notice Regarding Automated Employment Decision Tools which are available at jobot.com/legal. Proven experience with 1031 Exchanges, tax planning, federal and state tax, income tax preparation, gift tax, S Corp, tax returns, and corporate tax returns.
NewProject Manager III - Contract TalentBurst, Inc.Project Manager III - ContractWalkersville, MD$39.22–$65.35 / hourManage the complete life cycle and value chain of the assigned product portfolio within (market, competition, customer, and application intelligence) in close cooperation with the marketing manager and strategy teams to deliver on customer commitments as well as on sales and profit targets. Drive the forecasting process to provide a vital link between sales forecasts and production quantities to address demand exceptions, forecast new products, inventory management, and assist with prioritization in the event of supply challenges.
NewPayroll Manager Kforce Inc.Payroll ManagerBethesda, MD$48–$55Position Overview: We are seeking a hands-on Payroll Manager to own and manage end-to-end payroll operations in a fast-paced, high-volume environment. This individual will oversee full-cycle, in-house payroll processing, ensure compliance with applicable regulations, and serve as the primary point of contact for payroll-related inquiries.
NewTravel Nurse RN - Case Manager - $40 to $45 per hour in Sterling, VA Conflux Systems IncTravel Nurse RN - Case Manager - $40 to $45 per hour in Sterling, VASterling, VA$40–$45Through the use of clinical tools and information/data review, conducts comprehensive assessments of referred member's needs/eligibility and determines approach to case resolution and/or meeting needs by evaluating member's benefit plan and available internal and external programs/services. Description The Case Manager utilizes a collaborative process of assessment, planning, facilitation and advocacy for options and services to meet an individual's benefit plan and/or health needs through communication and available resources to promote optimal, cost-effective outcomes.
NewENGINEERING MANAGER Phoenix MecanoENGINEERING MANAGERFrederick, MDHigh-visibility leadership role with meaningful interaction across operations, sales, production, quality, and senior leadership both domestic and international. An Engineering Manager who enjoys leading technical teams, improving processes, and driving successful product and project outcomes will excel at this role.
NewLCSW-C, Social Work Case Manager Silver Spring, MD Holy Cross (24hrs.) Kaiser PermanenteLCSW-C, Social Work Case Manager Silver Spring, MD Holy Cross (24hrs.)Silver Spring, MDJob Summary:For members of a defined population, responsible for collaborating with the members of the health care team to facilitate the coordination of appropriate, cost-effective services that are consistent with members plan of care, help achieve his/her optimal level of independence, and enhance quality of life. Essential Responsibilities:Responsibilities include, but are not limited to, problem identification, psychosocial assessment, financial counseling/referral, accessing community resources, placement for care, guiding the member through health-related legal processes, or consultation and support to other health care professionals.
NewLCSW-Case Manager, Social Work- In Patient III Gaithersburg, MD Gaithersburg Medical Ctr. (16hrs.) Kaiser PermanenteLCSW-Case Manager, Social Work- In Patient III Gaithersburg, MD Gaithersburg Medical Ctr. (16hrs.)Gaithersburg, MD$45.92–$45.92For members of a defined population, responsible for collaborating with the members of the health care team to facilitate the coordination of appropriate, cost-effective services that are consistent with members plan of care, help achieve his/her optimal level of independence, and enhance quality of life. Responsibilities include, but are not limited to, problem identification, psychosocial assessment, financial counseling/referral, accessing community resources, placement for care, guiding the member through health-related legal processes, or consultation and support to other health care professionals.
NewLMSW-Case Manager, Social Work- In Patient II Gaithersburg, MD Gaithersburg Medical Ctr. (16hrs.) Kaiser PermanenteLMSW-Case Manager, Social Work- In Patient II Gaithersburg, MD Gaithersburg Medical Ctr. (16hrs.)Gaithersburg, MD$42.20–$42.20For members of a defined population, responsible for collaborating with the members of the health care team to facilitate the coordination of appropriate, cost-effective services that are consistent with members plan of care, help achieve his/her optimal level of independence, and enhance quality of life. Responsibilities include, but are not limited to, problem identification, psychosocial assessment, financial counseling/referral, accessing community resources, placement for care, guiding the member through health-related legal processes, or consultation and support to other health care professionals.
NewLMSW-Case Manager, Social Work- In Patient II Gaithersburg, MD Gaithersburg Med. Ctr (40hrs.) Kaiser PermanenteLMSW-Case Manager, Social Work- In Patient II Gaithersburg, MD Gaithersburg Med. Ctr (40hrs.)Gaithersburg, MD$42.20–$42.20Job Summary:For members of a defined population, responsible for collaborating with the members of the health care team to facilitate the coordination of appropriate, cost-effective services that are consistent with members plan of care, help achieve his/her optimal level of independence, and enhance quality of life. Essential Responsibilities:Responsibilities include, but are not limited to, problem identification, psychosocial assessment, financial counseling/referral, accessing community resources, placement for care, guiding the member through health-related legal processes, or consultation and support to other health care professionals.
NewProject Manager - Installation CoolSysProject Manager - InstallationAshburn, VA$90,000–$130,000Responsibilities: The MEC Project Managerwill be responsible for overseeing the installation of products, equipment, or systems for clients, ensuring that projects are completed on time, within budget, and according to specifications. This role involves coordinating and managing the entire installation process, including logistics, scheduling, resource allocation, and communication between clients, vendors, and installation teams.
NewCapture Manager (Hybrid) 2026-1473 Managed Care AdvisorsCapture Manager (Hybrid) 2026-1473Bethesda, MD$130,000–$135,000 / yearAll resumes submitted by search firms to any employee at the Sedgwick Government Solutions without a valid written agreement and task order in place will be deemed the sole property of Sedgwick Government Solutions and no fee will be paid in the event that person is hired by Sedgwick Government Solutions. As a Capture Manager, you will lead the strategy and execution of federal opportunities driving capture efforts from initial identification through proposal submission and supporting SGS’s continued growth.
Marketing and Leasing Manager - Multi-Family Property Management Pratum CompaniesMarketing and Leasing Manager - Multi-Family Property ManagementGaithersburg, MD$75,000–$90,000 / yearFull timeFamiliarity with industry-relevant marketing and technology platforms is required, including Yardi PMS, EliseAI CRM, Google Ads and Ad Words, AI-supported marketing tools, Microsoft Office Suite, Adobe Creative Suite, Canva, Flipbook platforms, SurveyMonkey, reputation management monitoring software, website design software tools, Mailchimp, Loomly, and social media optimization tools. The Marketing and Leasing Manager at Pratum Companies is responsible for developing and executing a results-driven marketing and resident strategy that directly supports leasing performance, occupancy growth, and overall asset value across a diverse multifamily portfolio.
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 Pratum CompaniesAssistant Community ManagerBethesda, MDFull timeThis role is non-exempt and has an anticipated pay range from $26.44 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.
Assistant Property Manager (Affordable Housing) Pratum CompaniesAssistant Property Manager (Affordable Housing)Bethesda, MDFull timeThis role is non-exempt and has an anticipated pay range from $26.44 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.
Assistant Community Manager (Affordable Housing) Pratum CompaniesAssistant Community Manager (Affordable Housing)Silver Spring, MDFull timeThis role is non-exempt and has an anticipated pay range starting at $23.50 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.
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 AstraZeneca PlcRegulatory Affairs ManagerGaithersburg, MD$109,245–$163,867 / yearIntegrated Project Management: Develop, execute and maintain submission delivery plans and content plans; proactively provide status updates to stakeholders; coordinate input, maintenance and revisions in Planit project plans; highlight unforeseen changes in resource demand to the Lead RPM and line manager. Submission Leadership: Lead and contribute to planning, preparation (including authoring where relevant) and delivery of simple and, with experience, increasingly complex submissions throughout the product lifecycle from global and/or regional perspectives; connect immediate deliverables to future label and lifecycle opportunities.
NewScientific 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 US Advertising and Promotion - Immunology AbbVie IncSenior Manager Regulatory Affairs US Advertising and Promotion - ImmunologyRockville, MDApplicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.
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 Dentsply Sirona IncRegulatory Affairs ManagerYork, PADentsply Sirona develops, manufactures, and markets a comprehensive solutions offering including dental and oral health products as well as other consumable medical devices under a strong portfolio of world class brands. This role works closely with business partners for registrations in their respective countries to ensure compliance globally and acts as an internal champion for initiatives aimed at improving business systems and compliance.
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.
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.
Regulatory Risk & Quality Manager CiconixRegulatory Risk & Quality ManagerFort Detrick, MarylandProvide subject matter expertise and support for the development and implementation of in-house quality systems and procedures, to include the development/writing of new SOPs to support ORA compliance Survey personnel, review procedures, assess facilities, and write SOPs for entities conducting or assisting with non-clinical studies, clinical studies, or manufacturing test articles (Deliverable 60). Summary:CICONIX is seeking a Regulatory Risk & Quality Manager to support the Office of Regulated Activities (ORA) in support of the Defense Health Agency Research and Development Medical Research and Development Command (DHA R&D MRDC) team in Fort Detrick, MD. About the Role:Provide Knowledge Management and Regulatory Risk and Quality Management support for medical product development within the ORA.
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.
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.
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.
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.
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.
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.
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.
Strategy Lead, CMC Mature, Regulatory Affairs GSK plcStrategy Lead, CMC Mature, Regulatory AffairsRockville, MD$113,850–$189,750 / 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. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment.
Director, Regulatory Affairs Strategy - Cell and Gene Therapy AstraZeneca PlcDirector, Regulatory Affairs Strategy - Cell and Gene TherapyGaithersburg, MD$186,232–$279,349 / yearPartnering with senior leaders and global teams, you will lead strategy across key milestones-from expedited designations and Health Authority interactions through major submissions and post-approval maintenance-helping the business deliver transformative therapies at pace and with rigor. In this Director role, you will shape the regulatory path for programs that span oncology, immune-mediated and rare diseases-translating breakthrough science into timely approvals and competitive labeling that make a tangible difference to patients and markets.
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.
Senior Regulatory Affairs Specialist (Columbia, MD) Smith & Nephew PlcSenior Regulatory Affairs Specialist (Columbia, MD)Columbia, MD$101,500–$152,250 / yearThe Senior Regulatory Affairs Specialist will be responsible for projects by leading regulatory submissions and designing comprehensive regulatory strategies on Human Cells, Tissues, and Cellular and Tissue-Based products (HCT/P) projects as well as define regulatory strategies for new device-led combination products. Act as NPD regulatory lead on new device-biologics combination products and define regulatory strategy for FDA submissions including authoring FDA 510(k) submissions and FDA pre-submissions.
NewSr. Principal Scientist (Sr. Director) - Regulatory Liaison Merck & Co IncSr. Principal Scientist (Sr. Director) - Regulatory LiaisonRockville, MD$190,800–$300,300 / yearRequired Skills: Biological Sciences, Clinical Reporting, Drug Development, Global Health, In Vitro Diagnostics (IVD), Multiple Therapeutic Areas, Pharmaceutical Regulatory Affairs, Process Improvements, Product Approvals, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Communications, Regulatory Compliance, Regulatory Issues, Regulatory Strategies, 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.
Regulatory/Accreditation Nurse Coordinator Trinity HealthRegulatory/Accreditation Nurse CoordinatorGermantown, MD$33.73–$50.59 / yearHoly Cross Health earns numerous national awards, clinical designations and accreditations across a wide range of specialties for providing innovative, high-quality health care services.\n \nNewsweek Accolades: Voted one of America's Greatest Workplaces for Diversity and America's Greatest Workplaces for Parents and Families 2024\n \nOur Commitment \n \nRooted in our Mission and Core Values, we honor the dignity of every person and recognize the unique perspectives, experiences, and talents each colleague brings. Must be able to read, write, speak and comprehend the English language and communicate verbally, electronically and on hard copy.\n \nReports to: Manager, Accreditation and Regulatory Affairs\n \nPay Range: $33.73-$50.59\n
CMC REGULATORY AFFAIRS CONSULTANT (SENIOR-LEVEL) SciLucent LLCCMC REGULATORY AFFAIRS CONSULTANT (SENIOR-LEVEL)Herndon, VARemote$115,000–$215,000 / yearOur scientific/regulatory consulting team is expanding, and we are seeking a mid-level experienced scientific professional with a strong CMC Regulatory Affairs background to join our team of experienced professional consultants. We offer a congenial, supportive, and flexible work environment, the opportunity to work with knowledgeable consultants, and the ability to develop a tremendous amount of knowledge and expertise across many stages and areas of healthcare product development.
CLINICAL DEVELOPMENT & REGULATORY AFFAIRS ASSOCIATE (ENTRY LEVEL) SciLucent LLCCLINICAL DEVELOPMENT & REGULATORY AFFAIRS ASSOCIATE (ENTRY LEVEL)Herndon, VARemote$50,000–$80,000 / yearThe ideal candidate will have the following: • Bachelor's degree, in a relevant scientific discipline (e.g., biology, chemistry, biochemistry, clinical research, etc.) or equivalent relevant scientific/regulatory/quality experience, is required. We offer a congenial, supportive, and flexible work environment, the opportunity to work with knowledgeable consultants, and the ability to develop a tremendous amount of knowledge and expertise across many stages and areas of healthcare product development.
Senior Regulatory Affairs Scientist CiconixSenior Regulatory Affairs ScientistFort Detrick, MarylandSummary:CICONIX is seeking a Senior Regulatory Affairs Scientist to support the Office of Regulated Activities (ORA) in support of the Defense Health Agency Research and Development Medical Research and Development Command (DHA R&D MRDC) team in Fort Detrick, MD. About the Role:Ensure compliance with FDA Sponsor responsibilities, serve as a subject matter expert for regulatory strategy including identifying and mitigating risk, and providing support to integrated project teams and working groups for submissions to and communications with the Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, and Center for Devices and Radiological Health submissions. The target product profiles shall contain the indication and usage, dosage and administration, dose forms and strengths, contraindications, warning and precautions, safety adverse reactions and drug interactions, use in specific populations, drug abuse and dependence/overdose, description of drug, clinical/pharmaceutical, pre-clinical toxicology, clinical studies, references, storage and handling, patient counseling, risk evaluation mitigation strategy, and supporting documentation and/or templates as appropriate.
CMC Director, Regulatory Affairs AltimmuneCMC Director, Regulatory AffairsGaithersburg, MDFull timeJob Description: This individual will be responsible for providing global regulatory CMC support throughout the product lifecycle (e.g., regulatory strategies, preparing CMC filings and submissions to regulatory applications, regulatory submission timeline development, and regulatory intelligence). Responsible for the preparation of all CMC sections/information filed in support of global clinical trial and marketing applications; ensures all CMC regulatory filings are prepared accurately and completed in a timely manner .
Director US Regulatory Policy GSK plcDirector US Regulatory PolicyRockville, MD$156,000–$260,000 / 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. Working across global and US-based teams, this role develops science-driven policy strategies, engages with regulatory agencies and external stakeholders, and supports enterprise-level advocacy priorities.
Director RA Regulatory Policy & Intelligence AbbVie IncDirector RA Regulatory Policy & IntelligenceRockville, MDActively engages to shape the US & ICH scientific and regulatory policy in the regulatory CMC, product quality and supply chain management space, partnering with cross-functional experts, and leading regulatory advocacy through trade associations, external organizations, and guidance consultations. The Director, Regulatory Affairs, U.S. Regulatory Policy & Intelligence (RPI), utilizes knowledge of the scientific, regulatory, and business environment regarding how medicinal products and medical devices are developed, evaluated, authorized and monitored once marketed to support and guide product development strategy.
NewRegulatory Scientific Reviewer (Chemist) US Department of Health and Human ServicesRegulatory Scientific Reviewer (Chemist)Silver Spring, MD$57,736–$76,557 / 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. Foreign Education: If you are using education completed in foreign colleges or universities to meet the qualification requirements, you must show that the education credentials have been evaluated by a private organization that specializes in interpretation of foreign education programs and such education has been deemed equivalent to that gained in an accredited U.S. education program; or full credit has been given for the courses at a U.S. accredited college or university.
Senior Manager, Drug Safety and Medical Monitor Supernus Pharmaceuticals IncSenior Manager, Drug Safety and Medical MonitorRockville, MD$131,000–$155,000 / yearConduct medical reviews of Individual Case Safety Reports (ICSRs), including Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), Adverse Drug Reactions (ADRs), causality assessments, signal detection, case narratives, aggregate reports, and safety data listings, and communicate all applicable comments to the Pharmacovigilance Lead. Conduct medical reviews of clinical trial documents including clinical trial protocols, informed consent forms, Investigator's Brochure and other essential study documents and plans, and provide input to Clinical Development, Medical Writing, and Clinical Operations teams.
Senior Manager, Drug Safety and Medical Monitor Supernus PharmaceuticalsSenior Manager, Drug Safety and Medical MonitorRockville, MarylandConduct medical reviews of Individual Case Safety Reports (ICSRs), including Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), Adverse Drug Reactions (ADRs), causality assessments, signal detection, case narratives, aggregate reports, and safety data listings, and communicate all applicable comments to the Pharmacovigilance Lead. Conduct medical reviews of clinical trial documents including clinical trial protocols, informed consent forms, Investigator’s Brochure and other essential study documents and plans, and provide input to Clinical Development, Medical Writing, and Clinical Operations teams.