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.
Senior Regulatory Affairs Specialist (Columbia, MD) Smith & Nephew PlcSenior Regulatory Affairs Specialist (Columbia, MD)Columbia, MD$101,500–$152,250 / yearThe Senior Regulatory Affairs Specialist will be responsible for projects by leading regulatory submissions and designing comprehensive regulatory strategies on Human Cells, Tissues, and Cellular and Tissue-Based products (HCT/P) projects as well as define regulatory strategies for new device-led combination products. Act as NPD regulatory lead on new device-biologics combination products and define regulatory strategy for FDA submissions including authoring FDA 510(k) submissions and FDA pre-submissions.
Regulatory Affairs Specialist (Innovation) Becton Dickinson and CoRegulatory Affairs Specialist (Innovation)MD$95,900–$153,400 / yearWaters collaborates with analytical laboratories around the world to advance the release of effective, high-quality medicines, assure the safety of food and water, and drive better patient outcomes by detecting diseases earlier, managing routine infections, and combatting growing antibiotic resistance. The Regulatory Affairs Specialist (Innovation) is responsible for providing regulatory guidance, developing regulatory strategies, and conducting risk assessments, to new product development (NPD) teams for in vitro diagnostic (IVD) products.
Regulatory Affairs Specialist, EHS, North America Henry Schein IncRegulatory Affairs Specialist, EHS, North AmericaMD$56,604–$88,443 / yearDevelop and deliver employee environmental, health, and safety (EHS) awareness and training programs to ensure compliance with applicable federal, state, and international regulations, including OSHA, OSHA State Plans (e.g., Cal/OSHA), DOT, IATA, IMO, and EPA requirements. Proficient in Microsoft Office applications, including PowerPoint, and experienced with project management methodologies and tools commonly used in the medical device or pharmaceutical industries.
Regulatory Specialist Stantec IncRegulatory SpecialistLaurel, MDThis position will be part of Stantec's Environmental Services team that provides the full range of expertise needed to address a variety of projects, including but not limited to supporting to public utilities, new electric transmission and rebuild projects, project access road planning and design, substation and battery storage facility design, solar due diligence and environmental permitting. Preparing technical reports for and managing coordination with the Maryland Department of the Environment (MDE), MD Department of Natural Resources (MD DNR), US Army Corps of Engineers (USACE), US Fish and Wildlife Service (USFWS), Environmental Protection Agency (EPA), and other federal, state, and local agencies.
Senior Reg Policy Specialist, Regulatory Financial Industry Regulatory Authority IncSenior Reg Policy Specialist, RegulatoryRockville, MDThe Senior Regulatory Policy Specialist provides high quality advice and support to OGC's Regulatory Policy and Capital Markets Group attorneys with respect to rulemaking and interpretive functions for the organization, and assists in providing legal and advisory support to other FINRA departments and committees, and interpretive guidance to FINRA members and others. FINRA employees are required to disclose to FINRA all brokerage accounts that they maintain, and those in which they control trading or have a financial interest (including any trust account of which they are a trustee or beneficiary and all accounts of a spouse, domestic partner or minor child who lives with the employee) and to authorize their broker-dealers to provide FINRA with duplicate statements for all of those accounts.
Sustaining & Compliance Projects Senior Manager, Regulatory Affairs Becton Dickinson and CoSustaining & Compliance Projects Senior Manager, Regulatory AffairsMD$149,600–$239,400 / yearWaters collaborates with analytical laboratories around the world to advance the release of effective, high-quality medicines, assure the safety of food and water, and drive better patient outcomes by detecting diseases earlier, managing routine infections, and combatting growing antibiotic resistance. Develops direct reports with regard to required competencies, including, but not limited to, regulatory knowledge and ability to apply this knowledge, effectiveness in team and one-to-one interactions, and verbal and written communications.
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.
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.
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.
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.
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 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).
Sr. 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.
Senior Regulatory Affairs Director - Oncology AstraZeneca PlcSenior Regulatory Affairs Director - OncologyGaithersburg, MD$211,581.60–$317,372.40 / 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. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
NewExecutive Director, Regulatory Affairs Strategy - Cell Therapy AstraZeneca PlcExecutive Director, Regulatory Affairs Strategy - Cell TherapyGaithersburg, MD$276,000–$414,000 / 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. GRST Leadership and Talent Development: Lead one or more Global Regulatory Strategy Teams focused on indications, programs, or franchise priorities; provide leadership, coaching, and performance feedback; line-manage 3-7 regulatory team members; contribute to succession planning, capability building, and development of senior regulatory talent.
Vice President, Global Head of Regulatory Affairs Qiagen NVVice President, Global Head of Regulatory AffairsGermantown, MDCreate practical solutions to complex regulatory challenges by setting policies and procedures, aligning cross-functional teams, and maintaining strong working relationships with government and non-government organizations that affect market access and distribution. Strategic experience and ability, having demonstrated success related to the development and implementation of pre-clinical and clinical strategies for clinical IVD products, implementation of regulatory systems, and assuring compliance to all applicable regulations.
Director Promotional Regulatory Affairs AstraZeneca PlcDirector Promotional Regulatory AffairsGaithersburg, MDDesirable Skills/Experience: • Advanced degree in life sciences, pharmacy, law, or a related discipline • 10 or more years of experience in US promotional regulatory affairs within biopharma, including direct OPDP/APLB interactions and resolution of advisory or enforcement matters • Experience leading or co-chairing MLR processes and operating within digital review systems such as AZAP or comparable platforms • Launch-to-lifecycle leadership across HCP and consumer promotions, managed markets materials, and omnichannel/digital campaigns • Proven ability to design and deliver effective regulatory training for commercial and medical stakeholders • Demonstrated influence at senior levels to shape departmental practices and operational plans • People leadership experience with a track record of coaching and building high-performing teams. Essential Skills/Experience: • Bachelor's degree in science • 3+ years' experience in promotional regulatory affairs, FDA (OPDP/APLB), or other equivalent experience in advertising and promotion review • 5+ years total experience in pharmaceutical/biotech industry, FDA, or equivalent experience • Strong knowledge of FDA promotional regulations and ability to apply such knowledge in review of diverse promotional materials and audiences • Knowledge of the drug development and labeling processes.
Senior Director, Regulatory Affairs Strategy - Cell and Gene Therapy AstraZeneca PlcSenior Director, Regulatory Affairs Strategy - Cell and Gene TherapyGaithersburg, MD$218,058–$327,087 / yearAccountabilities: Global Regulatory Leadership: Own the end-to-end global regulatory strategy for a high-complexity cell and gene therapy program, from current stage through BLA submission, ensuring an efficient route to approval with competitive labeling aligned to product attributes and patient, market and business needs. Cross-Functional Product Leadership: Represent Regulatory Affairs on Global Product Teams, shaping development and commercialization plans, contributing to governance presentations and aligning regulatory objectives with clinical, CMC, safety and commercial strategies.
Director of Regulatory Affairs,Tactical and Implementation Immunocore Holdings PlcDirector of Regulatory Affairs,Tactical and ImplementationGaithersburg, MD$157,500–$262,500 / yearExperience & knowledge Essential: • Solid track record in drug development and leadership within a dynamic project team • Emerging understanding of global regulatory requirements to be able to formulate tactical regulatory strategies • Ability to prepare and submit regulatory documentation to ensure regulatory compliance globally • Emerging ability to propose scientific regulatory strategies that are reviewed with line management for concurrence and approval • Excellent knowledge of US regulatory requirements and experience with submissions gained within drug development. The individual will also be assigned projects and regulatory activities by providing expertise to Immunocores development programs to include regulatory implementation of regulatory strategies, IND developments, submission, maintenance, tracking BLAs, BLA planning, submission, maintenance, tracking agency liaison for specific tactical assignments and regulatory intelligence for tactical process-related changes in requirements.
Associate Director Regulatory Affairs, Oncology GSK plcAssociate Director Regulatory Affairs, OncologyRockville, MD$138,750–$231,250 / yearThis role will ensure the development of appropriate global and/or regional regulatory strategy(s) and their execution for assigned asset(s) consistent with Medicines Development Strategy /Integrated Asset plan to ensure the development program meets the needs of the key markets identified and the Medicines Profile. Work with the Early/Medicine Development Team (EDT/MDT) or GRL, to ensure a robust regulatory strategy is in place to support the development program to meet the needs of the key markets identified in the Integrated Asset plan and the Medicine Profile.
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.
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.
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).
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.
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.
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.
Senior Regulatory Affairs Scientist CiconixSenior Regulatory Affairs ScientistFort Detrick, MarylandThe 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. 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.
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 Global Regulatory Affairs LancesoftDirector Global Regulatory AffairsBaltimore, MDRemote$302This role serves as a strategic integrator within the US team of the Global Regulatory Policy and Innovation (GRPI) team, translating emerging external policy, regulatory, and scientific developments into actionable insights that shape R&D and portfolio decisions. The position is designed to move beyond monitoring activity to influencing how the organization anticipates and navigates change, partnering closely across R&D, Regulatory, and Public Affairs to drive aligned and informed decision-making.
Director, Regulatory Affairs, Competitive Markets John Staurulakis (jsitel.com)Director, Regulatory Affairs, Competitive MarketsGreenbelt, MarylandPosition Overview: As a Director, Regulatory Affairs, Competitive Markets , you will serve as the face of our firm to a significant portfolio of client accounts spanning CLECs, MVNOs, nationwide telecommunications providers, and aggregators — acting simultaneously as trusted advisor, dedicated account manager, expert regulatory consultant and business development driver. Team Leadership & Supervision: Provide active leadership, direct supervision, and day-to-day guidance to junior consultants and support staff assigned to client accounts — setting priorities, removing barriers, ensuring accountability, and helping the team deliver accurate, timely, high-quality work.
Consultant, Regulatory Affairs John Staurulakis (jsitel.com)Consultant, Regulatory AffairsGreenbelt, MarylandClient Leadership & Account Management: Serve as the primary client representative and account manager for a large, diverse portfolio of accounts — including CLECs, MVNOs, nationwide telecom providers, and aggregators — ensuring exceptional service delivery and long-term client retention. JSI invites you to join our team as a Consultant, Regulatory Affairs on our Regulatory team in our Maitland, FL , Greenbelt, MD , or Remote locations where you'll play a critical role in advancing broadband and telecommunications initiatives that expand connectivity and drive digital inclusion—while advancing your career within a mission-driven, growth-focused organization.
R0000030967 Senior / Vice President, Technical - Clinical Regulatory Affairs (home-based) Parexel International CorpR0000030967 Senior / Vice President, Technical - Clinical Regulatory Affairs (home-based)MDWe're currently seeking a highly experienced Clinical Regulatory Leader, Health Authority Medical Review Team Lead, Master/Senior Medical Review Officer who is looking to draw upon their wealth of experience in clinical trial design and drug development to join Parexel's highly recognized Regulatory Strategy team! Minimum Work Experience - 15+ years experience with expert level industry or regulatory knowledge experience in Clinical Development/Clinical Trial Design, Clinical Strategy, and authoring clinical sections of regulatory applications.
Senior / Vice President, Technical - Clinical Regulatory Affairs (home-based) ParexelSenior / Vice President, Technical - Clinical Regulatory Affairs (home-based)MarylandWe’re currently seeking a highly experienced Clinical Regulatory Leader, Health Authority Medical Review Team Lead, Master/Senior Medical Review Officer who is looking to draw upon their wealth of experience in clinical trial design and drug development to join Parexel’s highly recognized Regulatory Strategy team! Minimum Work Experience - 15+ years experience with expert level industry or regulatory knowledge experience in Clinical Development/Clinical Trial Design, Clinical Strategy, and authoring clinical sections of regulatory applications.
Executive Director, Enterprise Regulatory Policy Strategy Merck & Co IncExecutive Director, Enterprise Regulatory Policy StrategyRockville, MD$231,900–$365,000 / yearDoctorate degree and at least 5 years' experience with FDA or other health authority, either directly (working within a health authority) or indirectly (closely interacting with health authority) OR Master's degree and at least 8 years' experience with FDA or other health authority, either directly (working within a health authority) or indirectly (closely interacting with health authority) OR Bachelor's degree and at least 10 years' experience with FDA or other health authority, either directly (working within a health authority) or indirectly (closely interacting with health authority), with demonstrated senior level experience engaging health authorities. The Executive Director (ED) will be a strong subject matter expert in regulatory processes, policies, laws, and regulations, with a deep understanding of how regulatory policy is shaped and influenced, and the credibility, relationships, and strategic judgment required to drive alignment and advance regulatory policy priorities in direct support of our Research and Development (R&D) goals, including enabling timely filings and accelerating pipeline progression through consistent, high impact external policy engagement.
Commercial & Healthcare Regulatory Counsel Alto IncCommercial & Healthcare Regulatory CounselMDRemote$135,000–$185,000 / yearPhysical requirements for this role include the ability to work at a computer terminal with monitor, keyboard and mouse for extended periods of time, stoop, bend, and reach for equipment and supplies, make frequent repetitive motions required to operate a computer that include the wrists, hands and fingers, and lift, carry, push, pull, and move light objects up to 20 pounds. Issue-spot and provide practical guidance on applicable laws and regulations, such as the Anti-Kickback Statute (AKS), Stark Law, False Claims Act, FDA/DEA requirements relevant to pharmacy and telehealth operations, state pharmacy/professional licensing, PBM contracting/network participation, and HIPAA/HITECH.
Senior Analyst, Regulatory John Staurulakis (jsitel.com)Senior Analyst, RegulatoryGreenbelt, MarylandJSI invites you to join our team as a Senior Analyst on our Regulatory team in our Greenbelt, MD or Austin, TX office where you'll play a critical role in advancing broadband and telecommunications initiatives that expand connectivity and drive digital inclusion—while advancing your career within a mission-driven, growth-focused organization. With clients nationwide and a powerful presence in markets across the United States, JSI empowers rural and regional broadband providers to expand, evolve, and excel in a rapidly shifting digital world.
Regulatory Coordinator - II ( Onsite Calverton ) US Oncology IncRegulatory Coordinator - II ( Onsite Calverton )Calverton, MDCookies 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. We're sorry, but it looks like this job may be no longer available or does not exist.
Food Safety Program Manager - Regulatory Support Chewy IncFood Safety Program Manager - Regulatory SupportSalisbury, 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.
NewSr. Medical Writer (Regulatory) Syneos HealthSr. Medical Writer (Regulatory)MarylandInteracts and builds good working relations with clients, department head, and peers in data management, biostatistics, regulatory affairs, and medical affairs, as necessary, to produce writing deliverables. • We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
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.
Regulatory Monitoring & DSMB Ops - Future Opportunities Digital InfuzionRegulatory Monitoring & DSMB Ops - Future OpportunitiesRockville, MDFull timeSystems & Documentation: Strong capability with documentation platforms and tracking tools (e.g., SharePoint or similar repositories, dashboards, trackers); disciplined approach to version control and record integrity. These roles help ensure participant safety and regulatory compliance by leading or supporting Data and Safety Monitoring Boards (DSMBs), Safety Committees, and related oversight activities.
Regulatory Coordinator - I ( Onsite Calverton ) Maryland OncologyRegulatory Coordinator - I ( Onsite Calverton )Beltsville, Maryland$26.02–$40.03 / hourJob Profile Summary Under general supervision is responsible for supporting the regulatory team with coordinating the research regulatory and administrative activities of clinical trials for the practice. Facilitates collection of site training documents from study initiation visits as well as coordinates and collects ongoing amendment training documents.
Sr Extern Affairs Specialist - BGE Permitting ExelonSr Extern Affairs Specialist - BGE PermittingBALTIMORE, MDWe are a Fortune 200 company, 20,000 colleagues strong serving more than 10.7 million customers at six energy companies -- Atlantic City Electric (ACE), Baltimore Gas and Electric (BGE), Commonwealth Edison (ComEd), Delmarva Power & Light (DPL), PECO Energy Company (PECO), and Potomac Electric Power Company (Pepco). + Bachelor’s degree in political science, communications, business administration, and/or public relations AND 4-7 years related experience in governmental affairs, customer service, communications, or relevant utility experience OR, in lieu of a bachelor’s degree, 6-9 years relevant experience is required.
Associate Health & Safety Specialist/Health & Safety Specialist/Sr. Health & Safety Specialist Berkshire Hathaway Energy CoAssociate Health & Safety Specialist/Health & Safety Specialist/Sr. Health & Safety SpecialistMDThrough our liquefied natural gas facilities, multi-state pipeline systems, and storage operations we support a number of large customers, including major utilities, power plants, marine transportation and heavy-duty trucking, along with manufacturing. BHE GT&S is an interstate natural gas transmission and storage company that gives large customers more options in moving gas safely, reliably and efficiently.
Key Management Specialist CymertekKey Management SpecialistAnnapolis JunctionCryptographic Key Manager, Encryption Specialist, Data Protection Analyst, Information Security Specialist, Cybersecurity Analyst, Cryptography Engineer, Security Operations Specialist, Key Access Control Analyst, Identity and Access Management Specialist, IT Security Specialist, Secure Communications Analyst, Data Security Engineer, Network Security Specialist, Key Lifecycle Manager, Digital Security Specialist, Compliance and Risk Analyst, Secure Storage Engineer, Threat Intelligence Analyst, Security Systems Administrator, etc. Cybersecurity, Computer Science, Information Technology, Information Systems, Computer Engineering, Network Engineering, Data Science, Information Assurance, Cryptography, Security Management, Telecommunications, Applied Mathematics, Systems Engineering, Digital Forensics, Software Engineering, Risk Management, Artificial Intelligence, Secure Communications, Compliance and Regulatory Affairs, Electrical Engineering, etc.
PKI (Public Key Infrastructure) Specialist CymertekPKI (Public Key Infrastructure) SpecialistAnnapolis JunctionPKI Engineer, Certificate Management Specialist, Cryptography Specialist, Encryption Engineer, Identity and Access Management Specialist, Cybersecurity Engineer, Security Operations Specialist, Key Management Specialist, Information Security Analyst, Cryptographic Systems Administrator, Secure Communications Specialist, IT Security Engineer, Authentication Systems Specialist, Digital Certificate Manager, Secure Infrastructure Engineer, Compliance and Risk Analyst, Network Security Specialist, Security Systems Administrator, Secure Software Specialist, etc. Cybersecurity, Computer Science, Information Technology, Information Systems, Computer Engineering, Network Engineering, Information Assurance, Cryptography, Data Science, Telecommunications, Applied Mathematics, Software Engineering, Systems Engineering, Security Management, Digital Forensics, Risk Management, Secure Communications, Electrical Engineering, Compliance and Regulatory Affairs, Artificial Intelligence, etc.
Specialist, Medical Affairs Becton Dickinson and CoSpecialist, Medical AffairsSparks, MD$75,800–$121,300 / yearWaters collaborates with analytical laboratories around the world to advance the release of effective, high-quality medicines, assure the safety of food and water, and drive better patient outcomes by detecting diseases earlier, managing routine infections, and combatting growing antibiotic resistance. This role provides insight on intended use, laboratory workflows, and patient impact/clinical unmet needs to help ensure alignment with real-world clinical practice while partnering with other Medical Affairs functions, as well as R&D, Quality, Regulatory, and Commercial teams.
NewQuality Control Specialist Actalent IncQuality Control SpecialistBaltimore, MDThe role collaborates closely with QC Microbiology, Manufacturing, Quality Assurance, Regulatory Affairs, Supply Chain, and Biologics Process Development teams to ensure timely analysis, inspection readiness, and robust data integrity across all QC activities. The specialist works hands-on in the Quality Control unit, coordinating QC samples for routine and qualification testing, supporting qualification studies through detailed report writing, and providing backup testing as needed.
Clinical Trial Specialist (Hybrid) Zp Group LlcClinical Trial Specialist (Hybrid)Bethesda, MD$50,000–$70,000 / yearThis role is hybrid (2 days on-site) and will play a key role in supporting clinical trial operations by ensuring the TMF is accurate, compliant and audit-ready. Qualifications of the Clinical Trial Specialist: 1-3+ years of regulatory submission/IRB experience working for a CRO, pharmaceutical/biotech, or research institution.